Clinical trial · Interventional
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
A Randomized Double-Blind Placebo-Controlled Study Of Oral Coenzyme Q10 To Relieve Self-Reported Cancer Treatment Related Fatigue In Breast Cancer Patients
NCT00096356CI-TRIAL-00054153CoQ10completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Fatigue | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CoQ10 & Vitamin E | Dietary Supplement | — | UNRESOLVED |
| Placebo & Vitamin E | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 - CoQ10 & Vitamin E
- description
- CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
- interventionNames
- Dietary Supplement: CoQ10 & Vitamin E
- Dietary Supplement: Placebo & Vitamin E
- type
- PLACEBO_COMPARATOR
- label
- Arm 2 - Placebo & Vitamin E
- description
- Placebo-Vitamin E 100 mg/day in 3 doses
- interventionNames
- Dietary Supplement: Placebo & Vitamin E
Primary outcomes (1)
- measure
- Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDVitolins 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. PMID 29731611
- RESULTLesser 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. PMID 22682875