Creatine in Treating Patients With Cancer-Associated Weight Loss

Phase 3

Completed

• Conditions: Anorexia; Cachexia; Unspecified Adult Solid Tumor, Protocol Specific; Weight Changes

• Registration Number: NCT00081250
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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 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.

Study Timeline

• Study First Submitted: 2004-04-07
• Study First Submitted QC: 2004-04-07
• Study First Posted: 2004-04-08
• Study Start: 2004-12
• Primary Completion: 2007-12
• Study Completion: 2017-07
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percentage of patients who gain weight over 1 month	1 month

Secondary Outcome Measures

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

Trial Locations

Locations (217)

Mobile Infirmary Medical Center; 🇺🇸 Mobile, Alabama, United States

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

Aurora Presbyterian Hospital; 🇺🇸 Aurora, Colorado, United States

Boulder Community Hospital; 🇺🇸 Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital; 🇺🇸 Colorado Springs, Colorado, United States

St. Anthony Central Hospital; 🇺🇸 Denver, Colorado, United States

Porter Adventist Hospital; 🇺🇸 Denver, Colorado, United States

Presbyterian - St. Luke's Medical Center; 🇺🇸 Denver, Colorado, United States

St. Joseph Hospital; 🇺🇸 Denver, Colorado, United States

Rose Medical Center; 🇺🇸 Denver, Colorado, United States

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