Phase 1
Completed N=236
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Source: ClinicalTrials.gov NCT00096356 ↗Enrolled (actual)
236
Serious AEs
19.2%
Results posted
Dec 2014
Primary outcomePrimary: Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization — 6.96; 8.33 units on a scale — p=0.1815
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization |
6.96; 8.33 | 0.1815 |
| SECONDARY Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization |
111.8; 109.8 | .3903 |
| SECONDARY Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization |
11.7; 12.4 | .6014 |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00096356). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.