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NCT01132547 · REGISTRY CONDITION SEARCH

Cyproheptadine in Preventing Weight Loss in Children Receiving Chemotherapy for Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
TERMINATED
Registry last update
2015-07-02

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline

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outcome · POSTED

Severity of Weight Loss

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outcome · POSTED

Pattern of Weight in the Study Population

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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.
healthy Volunteers
false
maximum Age
21 Years
minimum Age
2 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
    intervention Names
    1. Drug: cyproheptadine hydrochloride
    label
    Arm I cyproheptadine hydrochloride
    type
    EXPERIMENTAL
  2. description
    Patients receive an oral placebo twice daily for 8 weeks.
    intervention Names
    1. Other: placebo
    label
    Arm II placebo
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm I cyproheptadine hydrochloride
    description
    Given orally
    name
    cyproheptadine hydrochloride
    other Names
    1. cyproheptadine HCl
    type
    DRUG
  2. arm Group Labels
    1. Arm II placebo
    description
    Given orally
    name
    placebo
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
22
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
    time Frame
    8 weeks
  2. description
    Change from Baseline in Weight Z score
    measure
    Severity of Weight Loss
    time Frame
    Baseline and 8 weeks
secondary Outcomes
  1. description
    Change from Baseline in Weight
    measure
    Pattern of Weight in the Study Population
    time Frame
    Baseline and 8 weeks
Full study description
brief 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.
detailed Description
OBJECTIVES: Primary * To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy. Secondary * To investigate the effect of cyproheptadine HCl on the change in weight for age scores after 8 weeks of study drug administration in comparison to placebo. * Investigate the relationship between the secondary outcome variables (prealbumin, triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of treatment in each group (treatment and placebo) separately. 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. * Arm I: Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks. * Arm II: Patients receive an oral placebo twice daily for 8 weeks. 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.
Source references
Source notices and limitations
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      query disease state id
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      /studies/17/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      774aa0cf61008c10d57a9f35668b8933c61da657ebdc10570793fb3943e54c54
    11. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-b4775472cf609d239d36
      requested nct id
      NCT01132547
      primary nct id
      NCT01132547
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      payload sha256
      0ee2c2141de4e8ac4b5165210388b0756eb1505c60f7146577c9da8a8e34605f
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-b4775472cf609d239d36
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01132547
      occurrences
      1. context exact
        NCT01132547
        end
        11
        exact text
        NCT01132547
        start
        0
      offset unit
      unicode_code_points
      query cond
      Testicular Cancer
      query disease state id
      ds-testicular-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-testicular-cancer-000.json
      source file sha256
      9e542f373b689060c2c6c67507f6e2a629c92470fc1ae13d9359244ba59cb6b8
      source json pointer
      /studies/38/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      774aa0cf61008c10d57a9f35668b8933c61da657ebdc10570793fb3943e54c54
    12. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-c0301608f66fffe93c4f
      requested nct id
      NCT01132547
      primary nct id
      NCT01132547
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      b806e62fbec0949b986b68bc71cd425d7e95f5d6019e555b98173d8c38460df8
      payload sha256
      38d5db3b046d4d7ee72c35e1ba7fcdd4f396b6f7878fb3f64780553240b7d584
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-c0301608f66fffe93c4f
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01132547
      occurrences
      1. context exact
        NCT01132547
        end
        11
        exact text
        NCT01132547
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Ovarian Cancer
      query disease state id
      ds-ovarian-cancer-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-ovarian-cancer-000.json
      source file sha256
      b806e62fbec0949b986b68bc71cd425d7e95f5d6019e555b98173d8c38460df8
      source json pointer
      /studies/7/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      774aa0cf61008c10d57a9f35668b8933c61da657ebdc10570793fb3943e54c54

    Preserved source evidence · Not medical advice