Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer (NCT01132547) | Clinical Trial Compass
TerminatedPhase 3
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
Stopped: The study was terminated due to slow accrual.
United States22 participantsStarted 2010-06
Plain-language summary
RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer.
PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.
Who can participate
Age range2 Years – 21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA:
* ≥ 2 years and ≤ 21 years of age at the time of study entry
* Scheduled to receive chemotherapy for:
* Newly diagnosed:
* Non-rhabdo soft tissue sarcomas, scheduled to receive chemotherapy, as well as intermediate or high-risk rhabdomyosarcoma, any stage osteosarcoma and any stage Ewing's sarcoma
* Intermediate or high-risk neuroblastoma
* Wilms' tumor (Stage III/IV)
* Hepatoblastoma (Stage III/IV)
* Germ cell tumors (Stage III/IV)
* Brain tumors, including medulloblastoma, PNET and ependymomas
* AML
* Relapsed/recurrent disease (any patient)
* Able to register and randomize within 28 days of starting chemotherapy (registration /randomization and start of study agent may occur at anytime up to and including Day 28 after the initiation of chemotherapy)
EXCLUSION CRITERIA:
* ≥ 29 days after starting chemotherapy
* Documented history of unintended weight loss ≥ 5% presumed secondary to cancer within 3 months of study entry
* Currently taking cyproheptadine HCl (or have taken cyproheptadine HCl within 3 weeks of study registration)
* History of anorexia nervosa or bulimia
* Taking other appetite-stimulating medications, i.e. dronabinol (Marinol) during the past three weeks.
* Initiation of other appetite enhancing agents, including steroids prescribed for the intent of weight gain, i.e. Megace. Note: Other forms of nutrition therapies, e.g. appetite-stimulating medications, TPN or enteral tube feedings are not allowed during this study.
* Children receivin…
What they're measuring
1
Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline