A Phase 3 interventional study of cyproheptadine hydrochloride and placebo in Cancer, sponsored by University of South Florida. Terminated at 14 sites in United States. Open to participants aged 2 Years to 21 Years. Per ClinicalTrials.gov, last updated 2015-07-02.
Sponsored by University of South Florida · Phase 3, Interventional, and Supportive care
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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to enrolling center and steroid use with cancer treatment (yes vs no). Study agent can start anytime up to and including day 28 after the first dose of chemotherapy.
Patients undergo weight and height measurements at baseline and at each follow-up visit in weeks 4 and 8 to evaluate the effect of cyproheptadine hydrochloride and duration of response. Patients or parents complete medicine logs at each follow-up visit in weeks 4 and 8 to evaluate drug compliance and tolerance. Patients also undergo measures of nutrition; and measures of body composition, lean body mass, and fat percentage using standardized equipment and procedures for measuring triceps skin fold and mid-arm muscle circumference at baseline and at the end of the study.
Patients undergo blood sample collection at baseline and at the end of the study for biomarker studies. Samples are analyzed for pre-albumin levels.
1,767 studies on the registry are indexed under Weight Loss; 278 are open to participants now.
This study's enrollment of 22 is below the median of 73 across 1,497 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
Drug: cyproheptadine hydrochloride
Patients receive an oral placebo twice daily for 8 weeks.
Other: placebo
Given orally
Also known as: cyproheptadine HCl
Given orally
Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
Time frame: 8 weeks
Severity of Weight Loss
Change from Baseline in Weight Z score
Time frame: Baseline and 8 weeks
Pattern of Weight in the Study Population
Change from Baseline in Weight
Time frame: Baseline and 8 weeks
| Milestone | Arm I Cyproheptadine Hydrochloride | Arm II Placebo |
|---|---|---|
| Started | 9 | 13 |
| Completed | 5 | 12 |
| Not completed | 4 | 1 |
| Withdrew: Withdrawal by subject | 3 | 1 |
| Withdrew: Death | 1 | 0 |
| participants | Arm I Cyproheptadine Hydrochloride | Arm II Placebo |
|---|---|---|
| Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline | 0 | 2 |
Change from Baseline in Weight Z score
| Z score | Arm I Cyproheptadine Hydrochloride | Arm II Placebo |
|---|---|---|
| Severity of Weight Loss | 0.12 ± 1.15 | -0.02 ± 0.30 |
Change from Baseline in Weight
| Kilograms | Arm I Cyproheptadine Hydrochloride | Arm II Placebo |
|---|---|---|
| Pattern of Weight in the Study Population | 0.18 ± 0.79 | -0.32 ± 3.13 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I Cyproheptadine Hydrochloride | — | 3/9 (33.3%) | 4/9 (44.4%) |
| Arm II Placebo | — | 0/13 (0%) | 4/13 (30.8%) |
| Event | Arm I Cyproheptadine Hydrochloride | Arm II Placebo |
|---|---|---|
| Platelet count decreaseInvestigations | 2/9 | 0/13 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 2/9 | 0/13 |
| Intracranial hemorrhageNervous system disorders | 1/9 | 0/13 |
| Neutrophil count decreaseInvestigations | 1/9 | 0/13 |
| Event | Arm I Cyproheptadine Hydrochloride | Arm II Placebo |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 2/9 | 0/13 |
| Skin and Subcutaneous tissue disorders otherSkin and subcutaneous tissue disorders | 2/9 | 1/13 |
| FeverGeneral disorders | 2/9 | 0/13 |
| Febrile neutropeniaBlood and lymphatic system disorders | 1/9 | 0/13 |
| Abdominal painGastrointestinal disorders | 1/9 | 1/13 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 1/9 | 0/13 |
| HeadacheNervous system disorders | 1/9 | 1/13 |
| Allergic reactionImmune system disorders | 1/9 | 0/13 |
| HypertensionVascular disorders | 1/9 | 0/13 |
| Mucositis oralGastrointestinal disorders | 1/9 | 0/13 |
| Age, Continuous(years) | Arm I Cyproheptadine Hydrochloride | Arm II Placebo | Total |
|---|---|---|---|
| Mean | 10.2 ± 5.7 | 12.0 ± 4.7 | 11.2 ± 5.1 |
| Sex: Female, Male(Participants) | Arm I Cyproheptadine Hydrochloride | Arm II Placebo | Total |
|---|---|---|---|
| Female | 3 | 10 | 13 |
| Male | 6 | 3 | 9 |
| Region of Enrollment(participants) | Arm I Cyproheptadine Hydrochloride | Arm II Placebo | Total |
|---|---|---|---|
| United States | 9 | 13 | 22 |
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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