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Magnesium Oxide in Treating Postmenopausal Women With Hot Flashes and a History of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01439945
Recruitment Status : Completed
First Posted : September 23, 2011
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Cancer Survivor
Hot Flashes
Interventions Drug: magnesium oxide
Other: placebo
Enrollment 289
Recruitment Details  
Pre-assignment Details After the double blind phase patient were allowed to re-registered on the Optional Continuation Phase of the study. This phase lasted up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.
Arm/Group Title Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Low Dose Placebo High Dose Placebo
Hide Arm/Group Description

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two placebo tablets daily (QD).

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take three placebo tablets daily (QD).

Period Title: Double-Blind Treatment Phase
Started 97 96 48 48
Completed 93 91 45 46
Not Completed 4 5 3 2
Reason Not Completed
Withdrawal by Subject             3             3             3             1
Ineligible             1             2             0             1
Period Title: Optional Continuation Phase
Started 72 44 0 0
Completed 72 44 0 0
Not Completed 0 0 0 0
Arm/Group Title Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo Total
Hide Arm/Group Description

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two or three placebo tablets daily (QD).

Total of all reporting groups
Overall Number of Baseline Participants 93 91 91 275
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age Group Number Analyzed 93 participants 91 participants 91 participants 275 participants
18-49 years
15
  16.1%
15
  16.5%
15
  16.5%
45
  16.4%
>=50
78
  83.9%
76
  83.5%
76
  83.5%
230
  83.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 91 participants 91 participants 275 participants
Female
93
 100.0%
91
 100.0%
91
 100.0%
275
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 93 participants 91 participants 91 participants 275 participants
93 91 91 275
1.Primary Outcome
Title The Intra-patient Changes of Weekly Hot Flash Activity From Baseline During the Treatment Period.
Hide Description

The primary endpoint is the intra-patient changes of weekly hot flash activity from baseline during the treatment period. The hot flash activity will be measured by the weekly average hot flash score, which is a composite entity of both frequency and severity of hot flashes.

The hot flash severity is graded from 1 to 4 (1=mild, 2=moderate, 3=severe, and 4=very severe). The daily hot flash score is computed by multiplying the mean grade of severity by the frequency during every 24 hour period. Therefore, a score of zero is the lowest possible score and can be interpreted as having no hot flashes. The weekly hot flash score was calculated by adding all scores for the week.

The mean Hot Flash Score for each week for each group is reported and a repeated measures analysis is reported comparing each dose level group to the Placebo group.

Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.
Arm/Group Title Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo
Hide Arm/Group Description:

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two or three placebo tablets daily (QD).

Overall Number of Participants Analyzed 88 88 91
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 81 participants 81 participants 83 participants
16.02  (9.62) 15.35  (10.53) 17.28  (10.84)
Week 1 Number Analyzed 81 participants 78 participants 86 participants
14.28  (9.26) 14.47  (11.10) 15.52  (10.51)
Week 2 Number Analyzed 79 participants 78 participants 85 participants
12.68  (8.87) 12.59  (10.01) 13.29  (9.46)
Week 3 Number Analyzed 78 participants 76 participants 83 participants
12.29  (9.79) 11.32  (10.72) 12.34  (9.98)
Week 4 Number Analyzed 78 participants 73 participants 82 participants
11.73  (10.35) 10.14  (8.61) 12.02  (9.57)
Week 5 Number Analyzed 75 participants 67 participants 79 participants
11.77  (10.86) 9.73  (9.19) 11.63  (9.61)
Week 6 Number Analyzed 71 participants 67 participants 79 participants
11.61  (10.46) 9.44  (8.99) 11.17  (8.78)
Week 7 Number Analyzed 71 participants 67 participants 78 participants
11.92  (11.26) 9.37  (9.24) 10.71  (8.68)
Week 8 Number Analyzed 69 participants 66 participants 79 participants
12.17  (10.88) 9.06  (8.87) 11.42  (10.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose Magnesium Oxide (800 mg/Day), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method ANOVA
Comments Weekly hot flash score was treated as a repeated measure for each patient.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Dose Magnesium Oxide (1200 mg/Day), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method ANOVA
Comments Weekly hot flash score was treated as a repeated measure for each patient.
2.Secondary Outcome
Title Weekly Frequency of Hot Flashes as Measured by the Hot Flash Diary During the Treatment Period
Hide Description As part of the Hot Flash Diary, the number of hot flashes was recorded for each patient for each week. For this endpoint, the mean number of hot flashes for each group is reported. A repeated measure analysis comparing each dose level group and the Placebo is reported.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began protocol treatment and completed the Hot Flash Diary were included in this analysis.
Arm/Group Title Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo
Hide Arm/Group Description:

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two or three placebo tablets daily (QD).

Overall Number of Participants Analyzed 88 88 91
Mean (Standard Deviation)
Unit of Measure: number of hot flashes
Baseline Number Analyzed 81 participants 81 participants 83 participants
8.48  (4.34) 7.55  (3.89) 8.89  (4.52)
Week 1 Number Analyzed 81 participants 78 participants 86 participants
7.83  (4.34) 7.15  (4.13) 8.04  (4.59)
Week 2 Number Analyzed 79 participants 78 participants 85 participants
7.12  (4.18) 6.51  (4.19) 7.26  (4.65)
Week 3 Number Analyzed 78 participants 76 participants 83 participants
6.73  (4.41) 5.87  (4.21) 6.97  (4.82)
Week 4 Number Analyzed 78 participants 73 participants 82 participants
6.39  (4.51) 5.34  (3.76) 6.73  (4.44)
Week 5 Number Analyzed 75 participants 67 participants 79 participants
6.31  (4.70) 5.15  (4.00) 6.45  (4.33)
Week 6 Number Analyzed 71 participants 67 participants 79 participants
6.34  (4.56) 4.95  (4.04) 6.37  (4.30)
Week 7 Number Analyzed 71 participants 67 participants 78 participants
6.43  (4.68) 4.92  (4.13) 6.18  (4.23)
Week 8 Number Analyzed 69 participants 66 participants 79 participants
6.61  (4.58) 4.88  (4.02) 6.38  (4.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose Magnesium Oxide (800 mg/Day), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method ANOVA
Comments Weekly number of hot flashes were treated as a repeated measure for each patient.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Dose Magnesium Oxide (1200 mg/Day), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments Weekly number of hot flashes were treated as a repeated measure for each patient.
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Frequency and Maximum Grade of Adverse Events Reported Via the CTCAE 4.0 During the Treatment Period.
Hide Description Frequency and severity of adverse events reported by patients in weekly Symptom Experience Questionnaire and evaluated through clinical assessment by NCI CTCAE v3.0. The number of patients reporting grade 3 or higher events are reported in this outcome measure. For a full list of all events, please refer to the Adverse Events section of this report.
Time Frame Baseline to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that started protocol treatment and were evaluated for adverse events are included in this analysis.
Arm/Group Title Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo
Hide Arm/Group Description:

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two or three placebo tablets daily (QD).

Overall Number of Participants Analyzed 92 93 92
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3+ Adverse Event
5
   5.4%
1
   1.1%
2
   2.2%
Grade 4+ Adverse Event
0
   0.0%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title The Change of Severity of Symptoms as Measured the Symptom Experience Questionnaire From Baseline to Treatment Termination
Hide Description We will use the Symptom Experience Questionnaire (SEQ) to evaluate the specific impact of the study treatment on the effect hot flashes have on various life activities such as work, social, leisure and relationships. The questionnaire is 14 questions and is based on a 0="Not at all" to 10="As bad as it can be" scale. The change of severity of symptoms as measured by the SEQ from baseline to treatment termination will be first summarized by descriptive statistics as a percent change from baseline.
Time Frame Baseline to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that started treatment and completed the Symptom Experience Questionnaire at baseline and Cycle 9 were included in this analysis.
Arm/Group Title Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo
Hide Arm/Group Description:

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two or three placebo tablets daily (QD).

Overall Number of Participants Analyzed 79 80 82
Median (Full Range)
Unit of Measure: percentage change
Stomach Pain
0
(-40 to 60)
0
(-30 to 30)
0
(-60 to 40)
Diarrhea
0
(-50 to 20)
-5
(-90 to 50)
0
(-80 to 50)
Nausea
0
(-50 to 70)
0
(-70 to 50)
0
(-60 to 50)
Dizziness
0
(-20 to 50)
0
(-80 to 50)
0
(-30 to 20)
Decreased Appetite
0
(-10 to 50)
0
(-20 to 20)
0
(-40 to 30)
Fatigue
0
(-100 to 70)
0
(-40 to 70)
0
(-30 to 80)
Muscle Weakness
0
(-80 to 50)
0
(-50 to 70)
0
(-60 to 30)
Abnormal Sweating
10
(-80 to 90)
10
(-50 to 80)
10
(-80 to 80)
Constipation
0
(-70 to 70)
0
(-50 to 100)
0
(-50 to 70)
Muscle/Joint Aches
5
(-90 to 80)
10
(-80 to 60)
0
(-30 to 50)
Trouble Sleeping
10
(-40 to 80)
40
(-50 to 70)
10
(-40 to 100)
Negative mood change
0
(-50 to 50)
0
(-30 to 60)
0
(-70 to 80)
Trouble Concentrating
0
(-50 to 60)
0
(-30 to 50)
0
(-40 to 70)
Distress
10
(-60 to 100)
20
(-60 to 70)
10
(-60 to 80)
5.Secondary Outcome
Title The Change of Daily Interference as Measured by the Hot Flash Related Daily Interference Scale (HFRDIS) From Baseline to Treatment Termination.
Hide Description We will use the Hot Flash Related Daily Interference Scale (HFRDIS) (SEQ) to evaluate the specific effect of hot flashes have on various life activities such as work, social, leisure and relationships while receiving treatment. The questionnaire is 10 questions and is based on a 0="Do not interfere" to 10="Completely interfere" scale. The weekly score is the summation of these 10 questions and therefore ranges from 0 to 100. The total change in severity of symptoms is calculated by subtracting the week 8 score from the baseline. Therefore, values below zero indicate a worsening of symptoms and values above zero indicate an improvement and has a maximum range of -100 to 100. A gatekeeper procedure, following a fixed-sequence hypothesis testing method, was used to examine the higher dose of magnesium vs. placebo first and then the lower dose of magnesium vs. placebo, if the former was statistically significant.
Time Frame Baseline to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that began treatment and completed the HFRDI questionnaire at baseline and week 8 were used in this analysis.
Arm/Group Title High Dose Magnesium Oxide (1200 mg/Day) Placebo
Hide Arm/Group Description:

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two or three placebo tablets daily (QD).

Overall Number of Participants Analyzed 73 74
Median (Full Range)
Unit of Measure: units on a scale
7
(-26 to 45)
8.5
(-41 to 74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Magnesium Oxide (1200 mg/Day), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title The Intra-patient Changes of Magnesium Level From Baseline to the End of Treatment Period Between Magnesium Oxide and Placebo Arms.
Hide Description

The intra-patient changes of magnesium level from baseline to the end of treatment period between magnesium oxide and placebo arms will be compared using a repeated measures model.

Serum magnesium concentrations will be performed prior to study medication usage and during the last week of blinded study use. These will be obtained in the first 150 patients. Mean change in serum magnesium concentrations will be compared between the 3 study arms to determine whether there are any apparent changes in the patients receiving placebos vs the two magnesium doses.

Time Frame Baseline to week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All patients that started protocol treatment and had serum magnesium levels obtained at baseline and week 9 were included in this analysis.
Arm/Group Title Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo
Hide Arm/Group Description:

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two or three placebo tablets daily (QD).

Overall Number of Participants Analyzed 69 74 72
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.0  (0.2) 0.1  (0.2) 0.0  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose Magnesium Oxide (800 mg/Day), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection High Dose Magnesium Oxide (1200 mg/Day), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description All patients that began treatment and were assessed for adverse events (AEs) are reported. In the Low Dose arm, 97 patients were randomized, 5 were never assessed for AEs. In the High Dose arm, 96 patients were randomized, 3 patients were never assessed for AEs. In the placebo arms, 96 patients were randomized, 4 were never assessed for AEs. This leaves 92, 93, and 92 patients on Low Dose, High Dose and Placebo arms respectively assessed for Adverse events.
 
Arm/Group Title Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo Optional Continuation Phase
Hide Arm/Group Description

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 2:

Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Week 3:

Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Weeks 4-9:

Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD).

Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.

Week 2:

Patients take one placebo tablets orally (PO) daily (QD).

Week 3:

Patients take two placebo tablets daily (QD).

Weeks 4-9:

Patients take two or three placebo tablets daily (QD).

After the double blind phase patient questionnaire booklet has been completed and returned to the investigator, the patient will be told whether she was on magnesium or placebo. If the patient wishes to continue or start the magnesium, and healthcare provider approves that this is an appropriate option, she may be registered on the Optional Continuation Phase of the study. This phase will last up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.
All-Cause Mortality
Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo Optional Continuation Phase
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo Optional Continuation Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/92 (0.00%)      1/93 (1.08%)      0/92 (0.00%)      0/116 (0.00%)    
Gastrointestinal disorders         
Diarrhea  1  0/92 (0.00%)  0 1/93 (1.08%)  1 0/92 (0.00%)  0 0/116 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose Magnesium Oxide (800 mg/Day) High Dose Magnesium Oxide (1200 mg/Day) Placebo Optional Continuation Phase
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   67/92 (72.83%)      40/93 (43.01%)      31/92 (33.70%)      40/116 (34.48%)    
Cardiac disorders         
Chest pain - cardiac  1  0/92 (0.00%)  0 1/93 (1.08%)  1 0/92 (0.00%)  0 0/116 (0.00%)  0
Ear and labyrinth disorders         
Tinnitus  1  0/92 (0.00%)  0 1/93 (1.08%)  5 0/92 (0.00%)  0 0/116 (0.00%)  0
Endocrine disorders         
Endocrine disorders - Other, specify  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  1 0/116 (0.00%)  0
Eye disorders         
Blurred vision  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  1 0/116 (0.00%)  0
Eye disorders - Other, specify  1  0/92 (0.00%)  0 1/93 (1.08%)  5 0/92 (0.00%)  0 1/116 (0.86%)  2
Gastrointestinal disorders         
Abdominal distension  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Abdominal pain  1  5/92 (5.43%)  7 2/93 (2.15%)  3 3/92 (3.26%)  3 1/116 (0.86%)  2
Bloating  1  2/92 (2.17%)  3 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Constipation  1  2/92 (2.17%)  13 1/93 (1.08%)  1 1/92 (1.09%)  2 1/116 (0.86%)  4
Diarrhea  1  52/92 (56.52%)  137 26/93 (27.96%)  66 21/92 (22.83%)  37 32/116 (27.59%)  52
Dry mouth  1  1/92 (1.09%)  1 0/93 (0.00%)  0 1/92 (1.09%)  1 0/116 (0.00%)  0
Dyspepsia  1  1/92 (1.09%)  1 3/93 (3.23%)  5 2/92 (2.17%)  5 0/116 (0.00%)  0
Dysphagia  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  1 0/116 (0.00%)  0
Flatulence  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  5 0/116 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  0/92 (0.00%)  0 1/93 (1.08%)  1 0/92 (0.00%)  0 1/116 (0.86%)  1
Gastrointestinal pain  1  0/92 (0.00%)  0 1/93 (1.08%)  2 0/92 (0.00%)  0 1/116 (0.86%)  1
Hemorrhoidal hemorrhage  1  0/92 (0.00%)  0 1/93 (1.08%)  1 0/92 (0.00%)  0 0/116 (0.00%)  0
Hemorrhoids  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Lip pain  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  2 0/116 (0.00%)  0
Mucositis oral  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  2 0/116 (0.00%)  0
Nausea  1  10/92 (10.87%)  21 6/93 (6.45%)  7 3/92 (3.26%)  4 4/116 (3.45%)  7
Oral pain  1  1/92 (1.09%)  2 0/93 (0.00%)  0 1/92 (1.09%)  2 0/116 (0.00%)  0
Stomach pain  1  2/92 (2.17%)  2 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Vomiting  1  1/92 (1.09%)  1 1/93 (1.08%)  1 0/92 (0.00%)  0 0/116 (0.00%)  0
General disorders         
Fatigue  1  2/92 (2.17%)  11 1/93 (1.08%)  1 3/92 (3.26%)  5 2/116 (1.72%)  5
Immune system disorders         
Autoimmune disorder  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Infections and infestations         
Infections and infestations - Other, specify  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Papulopustular rash  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  2 0/116 (0.00%)  0
Upper respiratory infection  1  0/92 (0.00%)  0 1/93 (1.08%)  1 0/92 (0.00%)  0 0/116 (0.00%)  0
Injury, poisoning and procedural complications         
Bruising  1  1/92 (1.09%)  2 0/93 (0.00%)  0 0/92 (0.00%)  0 1/116 (0.86%)  1
Injury, poisoning and procedural complications - Other, specify  1  1/92 (1.09%)  2 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Metabolism and nutrition disorders         
Anorexia  1  0/92 (0.00%)  0 2/93 (2.15%)  2 1/92 (1.09%)  2 0/116 (0.00%)  0
Metabolism and nutrition disorders - Other, specify  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  2/92 (2.17%)  8 1/93 (1.08%)  1 1/92 (1.09%)  1 0/116 (0.00%)  0
Arthritis  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Back pain  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  1 0/116 (0.00%)  0
Generalized muscle weakness  1  0/92 (0.00%)  0 2/93 (2.15%)  2 0/92 (0.00%)  0 0/116 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, specify  1  1/92 (1.09%)  1 0/93 (0.00%)  0 1/92 (1.09%)  1 0/116 (0.00%)  0
Myalgia  1  1/92 (1.09%)  1 5/93 (5.38%)  10 0/92 (0.00%)  0 1/116 (0.86%)  2
Pain in extremity  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  2 0/116 (0.00%)  0
Nervous system disorders         
Dizziness  1  2/92 (2.17%)  14 1/93 (1.08%)  1 0/92 (0.00%)  0 2/116 (1.72%)  5
Headache  1  4/92 (4.35%)  6 2/93 (2.15%)  2 3/92 (3.26%)  3 1/116 (0.86%)  2
Psychiatric disorders         
Agitation  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Anxiety  1  1/92 (1.09%)  2 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Depression  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Insomnia  1  0/92 (0.00%)  0 2/93 (2.15%)  7 3/92 (3.26%)  4 0/116 (0.00%)  0
Renal and urinary disorders         
Cystitis noninfective  1  0/92 (0.00%)  0 1/93 (1.08%)  4 0/92 (0.00%)  0 0/116 (0.00%)  0
Reproductive system and breast disorders         
Dysmenorrhea  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Uterine pain  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Skin and subcutaneous tissue disorders         
Alopecia  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Pruritus  1  0/92 (0.00%)  0 0/93 (0.00%)  0 1/92 (1.09%)  2 0/116 (0.00%)  0
Rash acneiform  1  1/92 (1.09%)  3 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Vascular disorders         
Hot flashes  1  2/92 (2.17%)  2 1/93 (1.08%)  1 2/92 (2.17%)  8 0/116 (0.00%)  0
Hypertension  1  1/92 (1.09%)  1 0/93 (0.00%)  0 0/92 (0.00%)  0 0/116 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles Lawrence Loprinzi, M.D.
Organization: Mayo Clinic
EMail: cloprinzi@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01439945     History of Changes
Other Study ID Numbers: NCCTG-N10C2
NCCTG-N10C2
CDR0000711021 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2011-03537 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
First Submitted: September 22, 2011
First Posted: September 23, 2011
Results First Submitted: December 8, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017