Completed

Creatine in Treating Patients With Cancer-Associated Weight Loss

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What is being tested

creatine monohydrate

+ placebo
Dietary Supplement
Other
Who is being recruted

Anorexia
+1

+ Cachexia
+ Unspecified Adult Solid Tumor, Protocol Specific
Over 18 Years
How is the trial designed

Supportive Care Study

Placebo-Controlled
Phase 3
Interventional
Study Start: December 2004

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: April 29, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitlePhase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss 
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: April 29, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
300 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled
: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Anorexia
Cachexia
Unspecified Adult Solid Tumor, Protocol Specific
Weight Changes
Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed cancer other than primary brain cancer * Considered incurable with available therapies * History of weight loss ≥ 5 lbs in 2 months or fewer AND/OR estimated intake of \< 20 cal/kg daily * Determination by attending physician that weight gain would benefit patient * Perception by patient that weight loss is a problem * No symptomatic or untreated brain metastases * No clinical evidence of ascites PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 3 months Renal * Creatinine normal Cardiovascular * No poorly controlled congestive heart failure * No poorly controlled hypertension Other * Able to reliably receive oral medication * Must be alert and mentally competent * No known obstruction of the alimentary tract, malabsorption, or intractable vomiting * No diabetes that is controlled by insulin * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Chemotherapy * Concurrent chemotherapy allowed Endocrine therapy * No other concurrent adrenal corticosteroids, androgens, or progestational agents within 30 days after study entry * Concurrent short-term dexamethasone for chemotherapy-associated emesis is allowed * Concurrent inhalant, topical, or optical steroids allowed Radiotherapy * No concurrent radiotherapy to the bowel or stomach * Other concurrent radiotherapy allowed Other * No prior creatine use * No concurrent tube feedings or parenteral nutrition


Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Patients receive oral creatine daily.
Group II
Placebo
Patients receive oral placebo daily.
Study Objectives
Primary Objectives

Secondary Objectives


Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 220 locations
Suspended
Mobile Infirmary Medical CenterMobile, United StatesSee the location
Suspended
Mayo Clinic ScottsdaleScottsdale, United States
Suspended
Aurora Presbyterian HospitalAurora, United States
Suspended
Boulder Community HospitalBoulder, United States

Completed220 Study Centers