Clinical trial · Interventional
Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer
Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated due to slow accrual.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyproheptadine hydrochloride | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I cyproheptadine hydrochloride
- description
- Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
- interventionNames
- Drug: cyproheptadine hydrochloride
- type
- PLACEBO_COMPARATOR
- label
- Arm II placebo
- description
- Patients receive an oral placebo twice daily for 8 weeks.
- interventionNames
- Other: placebo
Primary outcomes (2)
- measure
- Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
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 receiving steroids for \>7 days as part of their cancer treatment regimen are excluded from participation. However, intermittent steroid use in an antiemetic regimen is allowed during the study * Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (Prozac), or paroxetine (Paxil) * Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease, or GI/GU obstruction * Allergy to cyproheptadine HCl * Females of childbearing age must not be pregnant. * Female patients who are lactating must agree to stop breast-feeding.
References
Publications (0)
Data not yet available