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Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer (CoQ10)

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: NCT00096356
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : December 29, 2014
Last Update Posted : September 29, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Breast Cancer
Fatigue
Interventions Dietary Supplement: CoQ10 & Vitamin E
Dietary Supplement: Placebo & Vitamin E
Enrollment 236
Recruitment Details Recruitment occurred in medical clinics
Pre-assignment Details There was no run-in period. Everyone enrolled was randomized.
Arm/Group Title Arm 1 - CoQ10 + Vitamin E Arm 2 - Placebo + Vitamin E
Hide Arm/Group Description CoQ10 + Vitamin E 100mg/day in 3 doses Placebo + Vitamin E 100mg/day in 3 doses
Period Title: Overall Study
Started 122 114
Completed 78 61
Not Completed 44 53
Reason Not Completed
Adverse Event             11             9
Physician Decision             5             3
Withdrawal by Subject             17             23
Lack of Efficacy             1             0
multiple reasons             10             18
Arm/Group Title Arm 1 - CoQ10 & Vitamin E Arm 2 - Placebo & Vitamin E Total
Hide Arm/Group Description CoQ10 plus Vitamin E 100mg/day in 3 doses Placebo plus Vitamin E 100mg/day in 3 doses Total of all reporting groups
Overall Number of Baseline Participants 122 114 236
Hide Baseline Analysis Population Description
All participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 114 participants 236 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
108
  88.5%
104
  91.2%
212
  89.8%
>=65 years
14
  11.5%
10
   8.8%
24
  10.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 122 participants 114 participants 236 participants
52.7  (9.4) 50.9  (9.7) 51.8  (9.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 122 participants 114 participants 236 participants
Female
122
 100.0%
114
 100.0%
236
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 122 participants 114 participants 236 participants
Hispanic 3 1 4
African-American 15 11 26
Caucasian 104 102 206
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 122 participants 114 participants 236 participants
122 114 236
1.Primary Outcome
Title Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
Hide Description POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - CoQ10 & Vitamin E Arm 2 - Placebo & Vitamin E
Hide Arm/Group Description:
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
Placebo-Vitamin E 100 mg/day in 3 doses
Overall Number of Participants Analyzed 122 114
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
6.96  (0.71) 8.33  (0.79)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 - CoQ10 & Vitamin E, Arm 2 - Placebo & Vitamin E
Comments Constrained repeated measures analysis of variance - constrained such that baseline fatigue was the same in both groups and unadjusted for any baseline covariates.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1815
Comments The a priori significance level was 0.05 for the primary outcome; there is no adjustment for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.37
Confidence Interval (2-Sided) 95%
-3.39 to 0.64
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.03
Estimation Comments This is the estimate of the difference in arms (Co-Q10 minus placebo). Lower is better for this outcome.
2.Secondary Outcome
Title Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization
Hide Description FACT-B stands for Functional Assessment of Cancer Therapy - Breast. It measures quality of life. It is the total of the FACT subscales (emotional, social, functional, and physical) and the Breast subscale. Scores range from 0 to 144; higher scores reflect better overall quality of life.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - CoQ10 & Vitamin E Arm 2 - Placebo & Vitamin E
Hide Arm/Group Description:
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
Placebo-Vitamin E 100 mg/day in 3 doses
Overall Number of Participants Analyzed 122 114
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
111.8  (1.81) 109.8  (1.96)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1 - CoQ10 & Vitamin E, Arm 2 - Placebo & Vitamin E
Comments Constrained repeated measures analysis of variance - constrained to have equal means at baseline, unadjusted for other covariates
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .3903
Comments 0.05 significance level; no multiple comparison adjustment
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
-2.56 to 6.53
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.31
Estimation Comments This is the difference in treatment groups at 24 weeks (Co-Q10 minus Placebo). Higher is better for this outcome.
3.Secondary Outcome
Title Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization
Hide Description CES-D is the Center for Epidemiologic Studies Depression Form. It consists of 20 questions. The total score ranges from 0 to 60. Higher scores indicate greater depression.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1- CoQ10 & Vitamin E Arm 2 - Placebo & Vitamin E
Hide Arm/Group Description:
CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
Placebo-Vitamin E 100 mg/day in 3 doses
Overall Number of Participants Analyzed 122 114
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
11.7  (0.96) 12.4  (1.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1- CoQ10 & Vitamin E, Arm 2 - Placebo & Vitamin E
Comments Constrained repeated measures analysis of variance, constrained such that the baseline means are equal, unadjusted of other covariates
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .6014
Comments 0.05 significance level, unadjusted for multiple comparisons
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.68
Confidence Interval (2-Sided) 95%
-3.25 to 1.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.31
Estimation Comments This is the difference between treatment groups at 24 weeks (Co-Q10 minus Placebo). Lower is better for this outcome.
Time Frame 28 weeks
Adverse Event Reporting Description One month past the end of treatment
 
Arm/Group Title Arm 1 - CoQ10 & Vitamin E Arm 2 - Placebo & Vitamin E
Hide Arm/Group Description CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day. Placebo-Vitamin E 100 mg/day in 3 doses
All-Cause Mortality
Arm 1 - CoQ10 & Vitamin E Arm 2 - Placebo & Vitamin E
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Arm 1 - CoQ10 & Vitamin E Arm 2 - Placebo & Vitamin E
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/100 (22.00%)      15/93 (16.13%)    
Blood and lymphatic system disorders     
ANC  1  11/100 (11.00%)  12 4/93 (4.30%)  4
WBC  1  4/100 (4.00%)  4 2/93 (2.15%)  2
anemia  1  1/100 (1.00%)  1 0/93 (0.00%)  0
Cardiac disorders     
hypotension  1  1/100 (1.00%)  1 0/93 (0.00%)  0
L vent sy d  1  0/100 (0.00%)  0 1/93 (1.08%)  1
chest pain  1  0/100 (0.00%)  0 1/93 (1.08%)  1
Gastrointestinal disorders     
constipation  1  1/100 (1.00%)  1 1/93 (1.08%)  1
diarrhea  1  3/100 (3.00%)  3 2/93 (2.15%)  2
ileus  1  1/100 (1.00%)  1 0/93 (0.00%)  0
vomiting  1  1/100 (1.00%)  1 1/93 (1.08%)  1
abd pain  1  0/100 (0.00%)  0 1/93 (1.08%)  1
nausea  1  1/100 (1.00%)  1 3/93 (3.23%)  3
General disorders     
allergic reaction  1  1/100 (1.00%)  1 0/93 (0.00%)  0
fatigue  1  1/100 (1.00%)  1 3/93 (3.23%)  4
fever  1  2/100 (2.00%)  2 1/93 (1.08%)  1
pain  1  1/100 (1.00%)  1 2/93 (2.15%)  3
hot flashes  1  0/100 (0.00%)  0 2/93 (2.15%)  4
headache  1  1/100 (1.00%)  1 0/93 (0.00%)  0
insomnia  1  0/100 (0.00%)  0 1/93 (1.08%)  1
Infections and infestations     
infection  1  2/100 (2.00%)  2 3/93 (3.23%)  4
Metabolism and nutrition disorders     
dehydration  1  3/100 (3.00%)  4 2/93 (2.15%)  2
Nervous system disorders     
dizziness  1  1/100 (1.00%)  1 0/93 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
bronchitis  1  1/100 (1.00%)  1 0/93 (0.00%)  0
Skin and subcutaneous tissue disorders     
cellulitis  1  2/100 (2.00%)  2 0/93 (0.00%)  0
rash  1  2/100 (2.00%)  2 1/93 (1.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm 1 - CoQ10 & Vitamin E Arm 2 - Placebo & Vitamin E
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   89/100 (89.00%)      84/93 (90.32%)    
General disorders     
alopecia  1  8/100 (8.00%)  16 11/93 (11.83%)  19
anorexia  1  11/100 (11.00%)  13 5/93 (5.38%)  7
arthralgia  1  6/100 (6.00%)  10 2/93 (2.15%)  3
constipation  1  13/100 (13.00%)  18 5/93 (5.38%)  7
cough  1  1/100 (1.00%)  1 6/93 (6.45%)  8
diarrhea  1  13/100 (13.00%)  17 17/93 (18.28%)  22
dizziness  1  13/100 (13.00%)  15 14/93 (15.05%)  15
edema  1  4/100 (4.00%)  4 10/93 (10.75%)  13
fatigue  1  48/100 (48.00%)  83 47/93 (50.54%)  80
fever  1  2/100 (2.00%)  2 5/93 (5.38%)  5
headache  1  16/100 (16.00%)  23 23/93 (24.73%)  31
heartburn  1  30/100 (30.00%)  48 27/93 (29.03%)  31
hot flashes  1  5/100 (5.00%)  6 7/93 (7.53%)  9
infection  1  4/100 (4.00%)  6 5/93 (5.38%)  5
insomnia  1  34/100 (34.00%)  53 26/93 (27.96%)  44
irritability  1  13/100 (13.00%)  16 13/93 (13.98%)  21
mucositis  1  11/100 (11.00%)  12 6/93 (6.45%)  7
myalgia  1  5/100 (5.00%)  5 5/93 (5.38%)  7
nausea  1  59/100 (59.00%)  75 52/93 (55.91%)  71
neuropathy  1  13/100 (13.00%)  19 10/93 (10.75%)  15
pain  1  15/100 (15.00%)  22 13/93 (13.98%)  20
rash  1  12/100 (12.00%)  15 19/93 (20.43%)  27
tachycardia  1  1/100 (1.00%)  1 5/93 (5.38%)  5
vomiting  1  9/100 (9.00%)  9 10/93 (10.75%)  10
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Glenn Lesser
Organization: Wake Forest University Comprehensive Cancer Center
Phone: (336) 713-5440
EMail: glesser@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00096356    
Other Study ID Numbers: REBACCCWFU-97202
U10CA081851 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: September 8, 2014
Results First Posted: December 29, 2014
Last Update Posted: September 29, 2021