Clinical trial · Interventional
Creatine in Treating Patients With Cancer-Associated Weight Loss
Phase III Double-Blind, Placebo-Controlled Randomized Comparison of Creatine for Cancer-Associated Weight Loss
NCT00081250CI-TRIAL-00044901completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
| Cachexia | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
| Weight Changes | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| creatine monohydrate | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral creatine daily.
- interventionNames
- Dietary Supplement: creatine monohydrate
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo daily.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Percentage of patients who gain weight over 1 month
- timeFrame
- 1 month
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.