Creatine in Treating Patients With Cancer-Associated Weight Loss (NCT00081250) | Clinical Trial Compass
CompletedPhase 3
Creatine in Treating Patients With Cancer-Associated Weight Loss
United States300 participantsStarted 2004-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested creatine specifically for cancer-related weight loss and muscle wasting — given my particular type of cancer and how much weight I've lost so far, do you think creatine supplementation is something worth considering for my situation?
2Since this was a Phase 3 trial that has now completed, have the final results been published, and did patients who took creatine actually gain meaningful weight compared to those who didn't?
3The trial focused on weight gain over just one month as its main measurement — does a one-month timeframe tell us enough about whether creatine has lasting benefits for cancer cachexia, or is the evidence still limited?
4Are there any safety concerns about taking creatine alongside my current cancer treatments, such as interactions with chemotherapy or effects on my kidneys, that the trial results might have flagged?
5Before considering something like creatine supplementation, are there standard nutritional or medical approaches to cancer-related weight loss that you'd recommend I try first, and how do they compare to what this trial was testing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients who gain weight over 1 month