Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096356
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2004-11-09
Brief Title:
Coenzyme Q10 in Relieving Treatment-Related Fatigue in Women With Breast Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CoQ10
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA081851 | NIH | None | httpsreporternihgovquickSearchU10CA081851 |