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Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Phase 1 trial testing CoQ10 & Vitamin E in Breast Cancer in 236 participants. Completed in 31 August 2009.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 236 |
| Start date | 27 August 2004 |
| Primary completion | 31 August 2009 |
| Estimated completion | 31 August 2009 |
| Sites | 31 locations across United States |
Wake Forest University Health Sciences
18 and older, female only, with Breast Cancer or Fatigue. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
POMS-F is the Profile of Mood States - fatigue scale. It ranges from 0 to 28; higher values indicate greater fatigue.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 - CoQ10 & Vitamin E | 6.96 | ± 0.71 |
| Arm 2 - Placebo & Vitamin E | 8.33 | ± 0.79 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1 - CoQ10 & Vitamin E | 111.8 | ± 1.81 |
| Arm 2 - Placebo & Vitamin E | 109.8 | ± 1.96 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Arm 1- CoQ10 & Vitamin E | 11.7 | ± 0.96 |
| Arm 2 - Placebo & Vitamin E | 12.4 | ± 1.05 |
Time frame: 28 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm 1 - CoQ10 & Vitamin E | Arm 2 - Placebo & Vitamin E |
|---|---|---|---|
| ANC | Blood and lymphatic system disorders | — | — |
| WBC | Blood and lymphatic system disorders | — | — |
| dehydration | Metabolism and nutrition disorders | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
| fatigue | General disorders | — | — |
| infection | Infections and infestations | — | — |
| nausea | Gastrointestinal disorders | — | — |
| cellulitis | Skin and subcutaneous tissue disorders | — | — |
| fever | General disorders | — | — |
| pain | General disorders | — | — |
| hot flashes | General disorders | — | — |
| rash | Skin and subcutaneous tissue disorders | — | — |
| allergic reaction | General disorders | — | — |
| anemia | Blood and lymphatic system disorders | — | — |
| bronchitis | Respiratory, thoracic and mediastinal disorders | — | — |
| constipation | Gastrointestinal disorders | — | — |
| dizziness | Nervous system disorders | — | — |
| hypotension | Cardiac disorders | — | — |
| ileus | Gastrointestinal disorders | — | — |
| vomiting | Gastrointestinal disorders | — | — |
| L vent sy d | Cardiac disorders | — | — |
| abd pain | Gastrointestinal disorders | — | — |
| chest pain | Cardiac disorders | — | — |
| headache | General disorders | — | — |
| insomnia | General disorders | — | — |
| Reaction | System | Arm 1 - CoQ10 & Vitamin E | Arm 2 - Placebo & Vitamin E |
|---|---|---|---|
| nausea | General disorders | — | — |
| fatigue | General disorders | — | — |
| insomnia | General disorders | — | — |
| heartburn | General disorders | — | — |
| headache | General disorders | — | — |
| rash | General disorders | — | — |
| diarrhea | General disorders | — | — |
| pain | General disorders | — | — |
| dizziness | General disorders | — | — |
| constipation | General disorders | — | — |
| irritability | General disorders | — | — |
| neuropathy | General disorders | — | — |
| alopecia | General disorders | — | — |
| anorexia | General disorders | — | — |
| mucositis | General disorders | — | — |
| edema | General disorders | — | — |
| vomiting | General disorders | — | — |
| hot flashes | General disorders | — | — |
| arthralgia | General disorders | — | — |
| cough | General disorders | — | — |
| fever | General disorders | — | — |
| infection | General disorders | — | — |
| myalgia | General disorders | — | — |
| tachycardia | General disorders | — | — |
Most-reported serious reactions: ANC, WBC, dehydration, diarrhea, fatigue, infection, nausea, cellulitis.
Data from ClinicalTrials.gov NCT00096356 adverse events section.
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.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing