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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)
[Not Specified]
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
Publications of Results:
Lesser GJ, Case D, Stark N, Williford S, Giguere J, Garino LA, Naughton MJ, Vitolins MZ, Lively MO, Shaw EG; Wake Forest University Community Clinical Oncology Program Research Base. A randomized, double-blind, placebo-controlled study of oral coenzyme Q10 to relieve self-reported treatment-related fatigue in newly diagnosed patients with breast cancer. J Support Oncol. 2013 Mar;11(1):31-42. doi: 10.1016/j.suponc.2012.03.003.
Other Publications:
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