Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer (CoQ10)
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|ClinicalTrials.gov Identifier: NCT00096356|
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : December 29, 2014
Last Update Posted : September 29, 2021
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|
- Determine the effect of coenzyme Q_10 on cancer treatment-related fatigue in women with breast cancer.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||236 participants|
|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 :||August 27, 2004|
|Actual Primary Completion Date :||August 31, 2009|
|Actual Study Completion Date :||August 31, 2009|
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 Name: 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
- Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization [ Time Frame: 24 weeks ]POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.
- Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization [ Time Frame: 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.
- Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096356
|Principal Investigator:||Glenn J. Lesser, MD||Wake Forest University Health Sciences|