Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081250
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2004-04-07
Brief Title:
Creatine in Treating Patients With Cancer-Associated Weight Loss
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
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 andor 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 andor 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:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-02584 | REGISTRY | None | None |
| CDR0000360798 | REGISTRY | PDQ Physician Data Query | None |