Cyproheptadine Hydrochloride and Nutritional Supplementation in Treating Young Patients With Weight Loss With Cancer
Condition: Leukemia; Lymphoma; Malnutrition; Myelodysplastic Syndromes; Unspecified Childhood Solid Tumor, Protocol Specific; Weight Changes
MeSH terms: Lymphoma; Leukemia; Preleukemia; Myelodysplastic Syndromes; Malnutrition; Syndrome; Body Weight; Weight Loss; Body Weight Changes
Intervention: Ensure; PediaSure; cyproheptadine hydrochloride
Intervention description: Given orally; Given orally; Given orally
Intervention MeSH terms: Cyproheptadine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: malnutrition; weight changes; childhood acute lymphoblastic leukemia in remission; recurrent childhood acute lymphoblastic leukemia; untreated childhood acute lymphoblastic leukemia; childhood acute myeloid leukemia in remission; recurrent childhood acute myeloid leukemia; untreated childhood acute myeloid leukemia; other myeloid malignancies; stage I childhood Hodgkin lymphoma; stage II childhood Hodgkin lymphoma; stage III childhood Hodgkin lymphoma; stage IV childhood Hodgkin lymphoma; recurrent/refractory childhood Hodgkin lymphoma; recurrent childhood anaplastic large cell lymphoma; stage I childhood anaplastic large cell lymphoma; stage II childhood anaplastic large cell lymphoma; stage III childhood anaplastic large cell lymphoma; stage IV childhood anaplastic large cell lymphoma; recurrent childhood grade III lymphomatoid granulomatosis; childhood diffuse large cell lymphoma; childhood immunoblastic large cell lymphoma; recurrent childhood large cell lymphoma; stage I childhood large cell lymphoma; stage II childhood large cell lymphoma; stage III childhood large cell lymphoma; stage IV childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; stage I childhood lymphoblastic lymphoma; stage II childhood lymphoblastic lymphoma; stage III childhood lymphoblastic lymphoma; stage IV childhood lymphoblastic lymphoma; childhood nasal type extranodal NK/T-cell lymphoma; childhood Burkitt lymphoma; recurrent childhood small noncleaved cell lymphoma; stage I childhood small noncleaved cell lymphoma; stage II childhood small noncleaved cell lymphoma; stage III childhood small noncleaved cell lymphoma; stage IV childhood small noncleaved cell lymphoma; childhood myelodysplastic syndromes; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; unspecified childhood solid tumor, protocol specific

Summary:

      RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss
      caused by cancer or cancer treatment. It is not yet known whether cyproheptadine
      hydrochloride is more effective with or without nutritional supplementation in improving
      weight and quality of life of young patients with weight loss caused by cancer or cancer
      treatment.

      PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how
      well it works when given together with or without nutritional supplementation in treating
      young patients with weight loss caused by cancer or cancer treatment.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  ≥ 2 years and < 18 years of age at the time of admission to the study

          -  Meets one of the following criteria:

          -  documented history of unintended weight loss > 5% presumed secondary to
             cancer/treatment-related therapy within three months

          -  BMI for age less than the 5th percentile

          -  Diagnosed with cancer of any type

          -  Concomitant cancer treatment (surgery, chemotherapy, radiotherapy) guidelines:

          -  Patients who will complete concomitant cancer treatment during this study's 4-week
             intervention are not eligible

          -  If patients are receiving concomitant cancer treatment, they should be scheduled to
             get at least another 4 weeks of treatment in order to reach the primary endpoint

          -  If patients have already completed cancer treatment, they need to be enrolled within 8
             weeks of completing therapy.

          -  Predicted life expectancy of at least 6 months

        EXCLUSION CRITERIA:

          -  Currently taking any of the study agents (cyproheptadine hydrochloride (CH),
             PediaSure, or Ensure) or have taken any of the study agents during the past 3 weeks

          -  History of anorexia nervosa or bulimia

          -  Initiation of other appetite enhancing agents including steroids prescribed for the
             intent of weight gain, i.e. Megace, is not allowed during this study

          -  Children receiving steroids as part of their daily cancer treatment regimen are
             excluded from participation. However, intermittent steroid use in an antiemetic
             regimen or in other pulse steroid therapy is allowed during the study.

          -  Use of other forms of nutrition therapies, e.g. total parenteral nutrition (TPN) or
             enteral tube feedings within 3 weeks of study entry or during study

          -  Receiving monoamine oxidase (MAO) inhibitors, procarbazine, fluoxetine (SSRI), or
             paroxetine (SSRI)

          -  Taking dronabinol (Marinol) or other appetite-stimulating medications during the past
             3 weeks

          -  Diagnosed with glaucoma, cystic fibrosis, inflammatory bowel disease or GI or
             genitourinary (GU) obstruction

          -  Allergy to study agents

          -  Hypersensitivity to specific milk proteins

          -  Pregnant or lactating. Females of childbearing potential are required to use effective
             contraception while on study agent.