Breast Cancer, Fatigue
Conditions
Keywords
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
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.
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.
Interventions
DIETARY_SUPPLEMENTPlacebo & Vitamin E
DIETARY_SUPPLEMENTCoQ10 & Vitamin E
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred in medical clinics
Pre-assignment details
There was no run-in period. Everyone enrolled was randomized.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 - CoQ10 & Vitamin E CoQ10 plus Vitamin E 100mg/day in 3 doses | 122 |
| Arm 2 - Placebo & Vitamin E Placebo plus Vitamin E 100mg/day in 3 doses | 114 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 9 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | multiple reasons | 10 | 18 |
| Overall Study | Physician Decision | 5 | 3 |
| Overall Study | Withdrawal by Subject | 17 | 23 |
Baseline characteristics
| Characteristic | Total | Arm 1 - CoQ10 & Vitamin E | Arm 2 - Placebo & Vitamin E |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 24 Participants | 14 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 212 Participants | 108 Participants | 104 Participants |
| Age, Continuous | 51.8 years STANDARD_DEVIATION 9.8 | 52.7 years STANDARD_DEVIATION 9.4 | 50.9 years STANDARD_DEVIATION 9.7 |
| Race/Ethnicity, Customized African-American | 26 participants | 15 participants | 11 participants |
| Race/Ethnicity, Customized Caucasian | 206 participants | 104 participants | 102 participants |
| Race/Ethnicity, Customized Hispanic | 4 participants | 3 participants | 1 participants |
| Region of Enrollment United States | 236 participants | 122 participants | 114 participants |
| Sex: Female, Male Female | 236 Participants | 122 Participants | 114 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 89 / 100 | 84 / 93 |
| serious Total, serious adverse events | 22 / 100 | 15 / 93 |
Outcome results
Primary
Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - CoQ10 & Vitamin E | Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization | 6.96 units on a scale | Standard Error 0.71 |
| Arm 2 - Placebo & Vitamin E | Effects of Coenzyme Q10 on Fatigue (as Measured by POMS-F) 24 Weeks Following Randomization | 8.33 units on a scale | Standard Error 0.79 |
Comparison: Constrained repeated measures analysis of variance - constrained such that baseline fatigue was the same in both groups and unadjusted for any baseline covariates.p-value: 0.181595% CI: [-3.39, 0.64]Mixed Models Analysis
Secondary
Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - CoQ10 & Vitamin E | Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization | 11.7 units on a scale | Standard Error 0.96 |
| Arm 2 - Placebo & Vitamin E | Effects of Coenzyme Q10 on Depression (as Measured by CES-D Short-form) 24 Weeks Following Randomization | 12.4 units on a scale | Standard Error 1.05 |
Comparison: Constrained repeated measures analysis of variance, constrained such that the baseline means are equal, unadjusted of other covariatesp-value: 0.601495% CI: [-3.25, 1.88]Mixed Models Analysis
Secondary
Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization
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
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 - CoQ10 & Vitamin E | Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization | 111.8 units on a scale | Standard Error 1.81 |
| Arm 2 - Placebo & Vitamin E | Effects of Coenzyme Q10 on Quality of Life (as Measured by FACT-B) 24 Weeks Following Randomization | 109.8 units on a scale | Standard Error 1.96 |
Comparison: Constrained repeated measures analysis of variance - constrained to have equal means at baseline, unadjusted for other covariatesp-value: 0.390395% CI: [-2.56, 6.53]Mixed Models Analysis