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Completed

NCT Number: NCT00066248

Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment

RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer.

PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.

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Key information

Conditions

Brain Tumor Astrocytoma Blast Crisis Body Weight Body Weight Changes Bone Marrow Diseases Brain Diseases Brain Neoplasms Burkitt Lymphoma Cachexia Carcinogenesis Cell Transformation, Neoplastic Central Nervous System Diseases Central Nervous System Neoplasms Central Nervous System Tumors Cerebral Ventricle Neoplasms Choroid Plexus Neoplasms Chronic Disease Cranial Nerve Diseases Cranial Nerve Neoplasms DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Epstein-Barr Virus Infections Eye Diseases Familial ependymoma Glioma Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myeloid, Chronic-Phase Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Medulloblastoma Myelodysplastic Syndromes Myelodysplastic-Myeloproliferative Diseases Myelodysplastic/Myeloproliferative Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Oligodendroglioma Optic Nerve Diseases Optic Nerve Glioma Optic Nerve Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Neoplasms Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence Signs and Symptoms Spinal Cord Diseases Spinal Cord Neoplasms Thinness Tumor Virus Infections Unspecified Childhood Solid Tumor, Protocol Specific Virus Diseases Weight Loss

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Sainte Justine, Montreal, Quebec, Canada

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About this study

OBJECTIVES:

  • Determine the efficacy of cyproheptadine in preventing further weight loss in children with cancer or cancer treatment-related cachexia.
  • Determine the efficacy of megestrol in preventing further weight loss in patients who don't respond to cyproheptadine.
  • Determine how these drugs affect body protein and fat levels in these patients.

OUTLINE: Patients receive oral cyproheptadine twice daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients that present with weight loss after 4 weeks receive oral megestrol daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients responding to either cyproheptadine or megestrol may continue treatment at the discretion of the treating physician.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any cachectic patient with weight loss presumed secondary to cancer or cancer related therapy is eligible. Cachexia is defined as having one or more of the following:
  • documented history of weight loss > 5%
  • drop in growth rate two or more percentile ranks on standard growth charts,
  • weight for height less than the tenth percentile.
  • Patients with newly diagnosed or relapsed cancer of any type, including brain tumors.
  • Patients who are receiving active or palliative therapy are eligible.
  • If patients have completed treatment for cancer (surgery, chemotherapy, radiotherapy) within 8 weeks of study registration, they are also eligible.
  • Patients must be ≥ 2 years and < 21 years of age at the time of admission to this study.
  • Patients must have a predicted life expectancy of at least eight weeks.

Exclusion criteria

  • Patients who are currently taking or who have taken Periactin and/or Megace during the past three weeks are not eligible.
  • Patients receiving corticosteroid or monoamine oxidase (MAO) inhibitor therapy. (Intermittent steroid use is permitted IF you anticipate it will not be administered for more than 7 days in a 4 week period. Calculate anticipated intermittent steroid use in 4-week intervals through the 8-week period during which study agent may be administered (4 weeks for Periactin and potentially 4 weeks for Megace.
  • Patients who have received parenteral nutrition or tube feedings within 1 week of starting this protocol or patients who are expected to require parenteral nutrition or tube feedings during the 4-week course of this study.
  • Patients taking dronabinol (Marinol) or other appetite-stimulating medications during the past three weeks or patients expected to be prescribed appetite-stimulating medications during the 4-week course of this study.
  • Patients with hormone sensitive tumors specifically meningiomas, breast cancer, ovarian cancer, and endometrial carcinoma.31, 32
  • Children with neurofibromatosis, type I or II, are at risk for the development of meningiomas and are thus excluded from this study.32
  • Children with glaucoma, chronic persistent asthma, or gastrointestinal (GI) or genitourinary (GU) obstruction.
  • Patients with recurrent and/or persistent hypertension, defined as blood pressure values >20% above normal.
  • Patients with thromboembolic disease, congestive heart failure, or peripheral edema.
  • Patients who are pregnant.

Treatment and study plan

cyproheptadine hydrochloride

Drug

Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.

Other names: Periactin

Megestrol acetate

Drug

Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.

Other names: Megace

Primary outcomes

  1. Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment

    Time frame: 4-8 weeks

Secondary outcomes

  1. Effect of study agents on protein and fat levels as measured by pre-albumin and lipid profile at baseline, and 4 weeks after the beginning of study treatment

    Time frame: 4-8 weeks

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Aug 7, 2003
Registry last updated
Feb 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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