Clinical Trial: Creatine in Treating Patients With Cancer-Associated Weight Loss

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss

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.


Detailed Summary:

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.


Sponsor: Alliance for Clinical Trials in Oncology

Current Primary Outcome: Percentage of patients who gain weight over 1 month [ Time Frame: 1 month ]

Original Primary Outcome:

Current Secondary Outcome:

  • Percentage of patients who manifest weight stability (i.e., weight within 5% of baseline) at 1 month [ Time Frame: 1 month ]
  • Percentage of patients who manifest stability in appetite [ Time Frame: Up to 5 years ]
  • Overall survival [ Time Frame: Up to 5 years ]
  • Incidence of treatment-related toxicity [ Time Frame: Up to 5 years ]
  • Quality of life [ Time Frame: Up to 5 years ]


Original Secondary Outcome:

Information By: Alliance for Clinical Trials in Oncology

Dates:
Date Received: April 7, 2004
Date Started: December 2004
Date Completion:
Last Updated: July 1, 2016
Last Verified: July 2016