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

• Sponsor: Wake Forest University Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT00096356
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 236
• Locations: 31
• Arms: 2
• Actual Duration (Months): 60.1
• Patients Per Site: 7.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

RATIONALE: Coenzyme Q10 is a vitamin that may be effective in relieving fatigue and depression in women who are undergoing chemotherapy for breast cancer.

PURPOSE: This randomized clinical trial is studying how well coenzyme Q10 works in relieving treatment-related fatigue in women with breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Fatigue	Dietary Supplement: CoQ10 & Vitamin E; Dietary Supplement: Placebo & Vitamin E	Phase 1

Detailed Description

OBJECTIVES:

Primary

• Determine the effect of coenzyme Q_10 on cancer treatment-related fatigue in women with breast cancer.

Secondary

• Determine the effect of this drug on overall quality of life of these patients.

• Determine the effect of this drug on depression in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to planned radiotherapy (yes vs no) and type of chemotherapy (anthracycline vs non-anthracycline). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Beginning on the first day of chemotherapy treatment, patients receive oral coenzyme Q_10 and oral vitamin E three times daily.

• Arm II: Beginning on the first day of chemotherapy treatment, patients receive oral vitamin E and an oral placebo three times daily.

Treatment in both arms continues for 24 weeks in the absence of unacceptable toxicity.

Quality of life, fatigue, and depression are assessed at baseline and at 8, 16, and 24 weeks.

PROJECTED ACCRUAL: A total of 101-236 patients will be accrued for this study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 236 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients
• Actual Study Start Date: Aug 27, 2004
• Actual Primary Completion Date: Aug 31, 2009
• Actual Study Completion Date: Aug 31, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 - CoQ10 & Vitamin E CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.	Dietary Supplement: CoQ10 & Vitamin E; Other Names: CoenzymeQ10 ; Dietary Supplement: Placebo & Vitamin E
Placebo Comparator: Arm 2 - Placebo & Vitamin E Placebo-Vitamin E 100 mg/day in 3 doses	Dietary Supplement: Placebo & Vitamin E

Outcome Measures

Primary Outcome Measures

1. Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization [24 weeks]

   POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.

Secondary Outcome Measures

1. Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization [24 weeks]

   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.

2. Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization [24 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed consent

• Hg > 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be utilized to assist with maintaining Hgb levels

• Total cholesterol > 160mg/dL.

• Female with primary cancer diagnosis (breast)

• Planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded)

• KPS > 60

• Bilirubin < 1.5 x ULN

• SGOT < 2.5 x ULN

• SGPT < 2.5 x ULN

Exclusion Criteria:

• Recent involuntary weight loss (> 5% of body weight in the past 3 months)

• Statin therapy - current or planned during study. Below is a list of some commonly used statin drugs.(Note: This is a helpful guide, not a complete list.)

• Atorvastatin (Lipitor)

• Cerivastatin

• Fluvastatin (Lescol)

• Lovastatin (Mevacor, Altocor, Advicor)

• Mevastatin

• Pravastatin (Pravachol)

• Rosuvastatin

• Simvastatin (Zocor)

• Current or planned use of the following medications for fatigue

• Corticosteroids (intermittent use as part of chemotherapy regimen is allowed)

• Amphetamines or other stimulants including methylphenidate (Ritalin)or modafinil (Provigil)

• Patients diagnosed with uncontrolled hypertension

• Breast cancer patients who are male

• Pregnant women are excluded from participation in this study. A Serum pregnancy test is required within 1 week of registration if the patient is a woman of childbearing potential.

• Anticoagulant therapy - current or planned during study (except for maintenance of catheter patency)

• Patients with uncontrolled thyroid dysfunction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CCOP - Western Regional, Arizona	Phoenix	Arizona	United States	85006-2726
2	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California	United States	95403
3	CCOP - Christiana Care Health Services	Newark	Delaware	United States	19713
4	Helen F. Graham Cancer Center at Christiana Hospital	Newark	Delaware	United States	19713
5	MBCCOP - Howard University Cancer Center	Washington	District of Columbia	United States	20060
6	CCOP - Mount Sinai Medical Center	Miami Beach	Florida	United States	33140
7	MBCCOP - JHS Hospital of Cook County	Chicago	Illinois	United States	60612
8	CCOP - Central Illinois	Decatur	Illinois	United States	62526
9	CCOP - Northern Indiana CR Consortium	South Bend	Indiana	United States	46601
10	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403
11	MBCCOP - LSU Health Sciences Center	New Orleans	Louisiana	United States	70112
12	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
13	CCOP - Beaumont	Royal Oak	Michigan	United States	48073-6769
14	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
15	CCOP - Heartland Research Consortium	Saint Louis	Missouri	United States	63131
16	Missouri Baptist Cancer Center	Saint Louis	Missouri	United States	63131
17	CCOP - St. Louis-Cape Girardeau	Saint Louis	Missouri	United States	63141
18	CCOP - Cancer Research for the Ozarks	Springfield	Missouri	United States	65804
19	Alamance Cancer Center at Alamance Regional Medical Center	Burlington	North Carolina	United States	27216
20	Southeastern Medical Oncology Center - Goldsboro	Goldsboro	North Carolina	United States	27534
21	Pardee Memorial Hospital	Hendersonville	North Carolina	United States	28791
22	High Point Regional Hospital	High Point	North Carolina	United States	27261
23	Caldwell Memorial Hospital	Lenoir	North Carolina	United States	28645
24	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
25	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina	United States	27157-1030
26	CCOP - Columbus	Columbus	Ohio	United States	43215
27	Cancer Centers of the Carolinas - Eastside	Greenville	South Carolina	United States	29615
28	South Carolina Cancer Specialists, PA at Hilton Head Medical Center	Hilton Head Island	South Carolina	United States	29925
29	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
30	Danville Regional Medical Center	Danville	Virginia	United States	24541
31	Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County	Martinsville	Virginia	United States	24115-4788

Sponsors and Collaborators

• Wake Forest University Health Sciences
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Glenn J. Lesser, MD, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

• Vitolins MZ, Case LD, Rapp SR, Lively MO, Shaw EG, Naughton MJ, Giguere J, Lesser GJ. Self-reported adherence and biomarker levels of CoQ10 and alpha-tocopherol. Patient Prefer Adherence. 2018 Apr 24;12:637-646. doi: 10.2147/PPA.S158682. eCollection 2018.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT00096356
• Other Study ID Numbers: REBACCCWFU-97202; U10CA081851
• First Posted: Nov 9, 2004
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Wake Forest University Health Sciences: fatigue; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer
• Additional relevant MeSH terms: Breast Neoplasms; Fatigue; Vitamins; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol

Study Results

Participant Flow

Recruitment Details	Recruitment occurred in medical clinics
Pre-assignment Detail	There was no run-in period. Everyone enrolled was randomized.

Arm/Group Title	Arm 1 - CoQ10 + Vitamin E	Arm 2 - Placebo + Vitamin E
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

Baseline Characteristics

Arm/Group Title	Arm 1 - CoQ10 & Vitamin E	Arm 2 - Placebo & Vitamin E	Total
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 Participants	122	114	236
Age (Count of Participants)
<=18 years	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 (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.7 (9.4)	50.9 (9.7)	51.8 (9.8)
Sex: Female, Male (Count of Participants)
Female	122 100%	114 100%	236 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (participants) [Number]
Hispanic	3 2.5%	1 0.9%	4 1.7%
African-American	15 12.3%	11 9.6%	26 11%
Caucasian	104 85.2%	102 89.5%	206 87.3%
Region of Enrollment (participants) [Number]
United States	122 100%	114 100%	236 100%

Outcome Measures

1. Primary Outcome

Title	Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 - CoQ10 & Vitamin E	Arm 2 - Placebo & Vitamin E
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
Measure Participants	122	114
Least Squares Mean (Standard Error) [units on a scale]	6.96 (0.71)	8.33 (0.79)

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
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
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1 - CoQ10 & Vitamin E	Arm 2 - Placebo & Vitamin E
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
Measure Participants	122	114
Least Squares Mean (Standard Error) [units on a scale]	111.8 (1.81)	109.8 (1.96)

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
Statistical Test of Hypothesis	p-Value	.3903
	Comments	0.05 significance level; no multiple comparison adjustment
	Method	Mixed Models Analysis
	Comments
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1- CoQ10 & Vitamin E	Arm 2 - Placebo & Vitamin E
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
Measure Participants	122	114
Least Squares Mean (Standard Error) [units on a scale]	11.7 (0.96)	12.4 (1.05)

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
Statistical Test of Hypothesis	p-Value	.6014
	Comments	0.05 significance level, unadjusted for multiple comparisons
	Method	Mixed Models Analysis
	Comments
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.

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
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%)		15/93 (16.1%)
Blood and lymphatic system disorders
ANC	11/100 (11%)	12	4/93 (4.3%)	4
WBC	4/100 (4%)	4	2/93 (2.2%)	2
anemia	1/100 (1%)	1	0/93 (0%)	0
Cardiac disorders
hypotension	1/100 (1%)	1	0/93 (0%)	0
L vent sy d	0/100 (0%)	0	1/93 (1.1%)	1
chest pain	0/100 (0%)	0	1/93 (1.1%)	1
Gastrointestinal disorders
constipation	1/100 (1%)	1	1/93 (1.1%)	1
diarrhea	3/100 (3%)	3	2/93 (2.2%)	2
ileus	1/100 (1%)	1	0/93 (0%)	0
vomiting	1/100 (1%)	1	1/93 (1.1%)	1
abd pain	0/100 (0%)	0	1/93 (1.1%)	1
nausea	1/100 (1%)	1	3/93 (3.2%)	3
General disorders
allergic reaction	1/100 (1%)	1	0/93 (0%)	0
fatigue	1/100 (1%)	1	3/93 (3.2%)	4
fever	2/100 (2%)	2	1/93 (1.1%)	1
pain	1/100 (1%)	1	2/93 (2.2%)	3
hot flashes	0/100 (0%)	0	2/93 (2.2%)	4
headache	1/100 (1%)	1	0/93 (0%)	0
insomnia	0/100 (0%)	0	1/93 (1.1%)	1
Infections and infestations
infection	2/100 (2%)	2	3/93 (3.2%)	4
Metabolism and nutrition disorders
dehydration	3/100 (3%)	4	2/93 (2.2%)	2
Nervous system disorders
dizziness	1/100 (1%)	1	0/93 (0%)	0
Respiratory, thoracic and mediastinal disorders
bronchitis	1/100 (1%)	1	0/93 (0%)	0
Skin and subcutaneous tissue disorders
cellulitis	2/100 (2%)	2	0/93 (0%)	0
rash	2/100 (2%)	2	1/93 (1.1%)	1
Other (Not Including Serious) Adverse Events
	Arm 1 - CoQ10 & Vitamin E		Arm 2 - Placebo & Vitamin E
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	89/100 (89%)		84/93 (90.3%)
General disorders
alopecia	8/100 (8%)	16	11/93 (11.8%)	19
anorexia	11/100 (11%)	13	5/93 (5.4%)	7
arthralgia	6/100 (6%)	10	2/93 (2.2%)	3
constipation	13/100 (13%)	18	5/93 (5.4%)	7
cough	1/100 (1%)	1	6/93 (6.5%)	8
diarrhea	13/100 (13%)	17	17/93 (18.3%)	22
dizziness	13/100 (13%)	15	14/93 (15.1%)	15
edema	4/100 (4%)	4	10/93 (10.8%)	13
fatigue	48/100 (48%)	83	47/93 (50.5%)	80
fever	2/100 (2%)	2	5/93 (5.4%)	5
headache	16/100 (16%)	23	23/93 (24.7%)	31
heartburn	30/100 (30%)	48	27/93 (29%)	31
hot flashes	5/100 (5%)	6	7/93 (7.5%)	9
infection	4/100 (4%)	6	5/93 (5.4%)	5
insomnia	34/100 (34%)	53	26/93 (28%)	44
irritability	13/100 (13%)	16	13/93 (14%)	21
mucositis	11/100 (11%)	12	6/93 (6.5%)	7
myalgia	5/100 (5%)	5	5/93 (5.4%)	7
nausea	59/100 (59%)	75	52/93 (55.9%)	71
neuropathy	13/100 (13%)	19	10/93 (10.8%)	15
pain	15/100 (15%)	22	13/93 (14%)	20
rash	12/100 (12%)	15	19/93 (20.4%)	27
tachycardia	1/100 (1%)	1	5/93 (5.4%)	5
vomiting	9/100 (9%)	9	10/93 (10.8%)	10

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT 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.