Clinical trial NCT00949117 (phase 2, status: terminated)
Conditions: leukemia, lymphoma, malnutrition, myelodysplastic syndromes, unspecified childhood solid tumor, protocol specific, weight changes
ICD codes: C95.91, C95.92, Z80.6, Z85.6, C90.11, C90.12, C91.01, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, O25.2, E44.0, E44.1, E46, O25.3, E43, E64.0, D46.9, D46.C, D46.Z, H01.009, H02.209, H02.009, H02.109, H04.209, H05.409, H10.509
Drugs: cyproheptadine hydrochloride
SMILES: CN1CCC(CC1)=C1C2=CC=CC=C2C=CC2=CC=CC=C12
Reason stopped: 
    study not feasible with low accrual. dsmb recommended closure
  
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.