Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-30 @ 3:51 PM
Study NCT ID:
NCT00081250
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2004-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creatine in Treating Patients With Cancer-Associated Weight Loss
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
Status:
COMPLETED
Status Verified Date:
2020-04
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:
None
Brief Summary:
RATIONALE: It is not yet known whether the supplement creatine is effective in increasing weight and improving appetite and quality of life in patients who have cancer.
PURPOSE: This randomized phase III trial is studying how well creatine works in increasing weight and improving appetite and quality of life in patients with weight loss caused by cancer.
PURPOSE: This randomized phase III trial is studying how well creatine works in increasing weight and improving appetite and quality of life in patients with weight loss caused by cancer.
Detailed Description:
OBJECTIVES:
* Compare weight-gain effects of creatine vs placebo in patients with cancer-associated weight loss and/or anorexia.
* Determine the effect of these regimens on quality of life in these patients.
* Compare the toxic effects of these regimens in these patients.
* Compare survival rates of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to primary cancer type (lung vs gastrointestinal vs other), weight loss severity (\< 10 lbs vs ≥10 lbs), age (\< 50 years vs ≥ 50 years), planned concurrent chemotherapy (yes vs no), gender, and prognosis. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral creatine daily.
* Arm II: Patients receive oral placebo daily. In both arms, treatment continues in the absence of unacceptable toxicity as long as treatment is considered beneficial.
Patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
* Compare weight-gain effects of creatine vs placebo in patients with cancer-associated weight loss and/or anorexia.
* Determine the effect of these regimens on quality of life in these patients.
* Compare the toxic effects of these regimens in these patients.
* Compare survival rates of patients treated with these regimens.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to primary cancer type (lung vs gastrointestinal vs other), weight loss severity (\< 10 lbs vs ≥10 lbs), age (\< 50 years vs ≥ 50 years), planned concurrent chemotherapy (yes vs no), gender, and prognosis. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral creatine daily.
* Arm II: Patients receive oral placebo daily. In both arms, treatment continues in the absence of unacceptable toxicity as long as treatment is considered beneficial.
Patients are followed every 6 months for up to 5 years.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: