Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
This study has been completed.
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00066248
First received: August 6, 2003
Last updated: May 9, 2009
Last verified: May 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Cachexia Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: cyproheptadine hydrochloride Drug: megestrol acetate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia |
Resource links provided by NLM:
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Weight Control
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 70 |
| Study Start Date: | June 2003 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
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 cyprohepatadine 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.
Eligibility| Ages Eligible for Study: | 2 Years to 20 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed or relapsed cancer of any type, including brain tumors
Cachexia with weight loss presumed secondary to cancer or cancer-related treatment defined as 1 or more of the following:
- Documented weight loss of at least 5%
- Drop in growth rate 2 or more percentile ranks on standard growth charts
- Weight for height less than the tenth percentile
- No hormone-sensitive tumors (i.e., meningiomas, breast cancer, ovarian cancer, or endometrial cancer)
PATIENT CHARACTERISTICS:
Age
- 2 to 20
Performance status
- Not specified
Life expectancy
- At least 8 weeks
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No thromboembolic disease
- No congestive heart failure
- No recurrent or persistent hypertension (i.e., blood pressure values greater than 20% above normal)
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No type I or II neurofibromatosis
- No glaucoma
- No chronic persistent asthma
- No gastrointestinal or genitourinary obstruction
- No peripheral edema
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No more than 8 weeks since prior chemotherapy
Endocrine therapy
- No concurrent corticosteroids except intermittent steroid use (≤ 7 days in a 4 week period)
Radiotherapy
- No more than 8 weeks since prior radiotherapy
Surgery
- No more than 8 weeks since prior surgery
- Concurrent tumor-debulking surgery, limb-sparing surgery, or amputation allowed
Other
- More than 3 weeks since prior cyproheptadine or megestrol
- More than 3 weeks since prior dronabinol or other appetite-stimulating medications
- More than 1 week since prior parenteral nutrition or tube feedings
- No more than 8 weeks since prior other anticancer therapy
- No other concurrent appetite-stimulating medications
- No concurrent parenteral nutrition or tube feedings
- No concurrent monoamine oxidase inhibitors (e.g., moclobemide, phenelzine, or tranylcypromine)
- Concurrent active or palliative therapy allowed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066248
Show 43 Study Locations
Show 43 Study LocationsSponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
| Study Chair: | Jennifer L. Mayer, MD | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00066248 History of Changes |
| Other Study ID Numbers: | CDR0000309056, MCC-0205 |
| Study First Received: | August 6, 2003 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
cachexia unspecified childhood solid tumor, protocol specific childhood spinal cord neoplasm recurrent childhood medulloblastoma untreated childhood medulloblastoma childhood high-grade cerebral astrocytoma childhood low-grade cerebral astrocytoma recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma untreated childhood cerebellar astrocytoma childhood oligodendroglioma recurrent childhood brain stem glioma recurrent childhood visual pathway and hypothalamic glioma untreated childhood brain stem glioma untreated childhood visual pathway and hypothalamic glioma |
recurrent childhood supratentorial primitive neuroectodermal tumor untreated childhood supratentorial primitive neuroectodermal tumor childhood craniopharyngioma childhood infratentorial ependymoma childhood supratentorial ependymoma newly diagnosed childhood ependymoma recurrent childhood ependymoma childhood choroid plexus tumor childhood central nervous system germ cell tumor 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 and other myeloid malignancies |
Additional relevant MeSH terms:
|
Cachexia Leukemia Lymphoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Nervous System Neoplasms Lymphoma, Non-Hodgkin Central Nervous System Neoplasms Myelodysplastic-Myeloproliferative Diseases Emaciation Weight Loss Body Weight Changes Body Weight Signs and Symptoms |
Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms by Site Nervous System Diseases Cyproheptadine Megestrol Megestrol Acetate Anti-Allergic Agents |
ClinicalTrials.gov processed this record on May 16, 2013