Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment
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| ClinicalTrials.gov Identifier: NCT00066248 |
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Recruitment Status :
Completed
First Posted : August 7, 2003
Last Update Posted : February 3, 2014
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Sponsor:
University of South Florida
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain Tumor 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 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 70 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (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 |
| Study Start Date : | June 2003 |
| Actual Primary Completion Date : | August 2007 |
| Actual Study Completion Date : | August 2007 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Body Weight
Genetic and Rare Diseases Information Center resources:
Glioblastoma
Myeloid Leukemia
Acute Myeloid Leukemia
Acute Non Lymphoblastic Leukemia
Lymphosarcoma
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Childhood Acute Lymphoblastic Leukemia
Myelodysplastic Syndromes
Chronic Myelomonocytic Leukemia
Juvenile Myelomonocytic Leukemia
Primary Central Nervous System Lymphoma
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Chronic Myeloproliferative Disorders
Glioma
Hodgkin Lymphoma
Medulloblastoma
Medulloblastoma, Childhood
Oligodendroglioma
Hairy Cell Leukemia
Brain Tumor, Childhood
Craniopharyngioma
Myelodysplastic/myeloproliferative Disease
Optic Pathway Glioma
Ependymoma
Neuroepithelioma
Childhood Brain Stem Glioma
Supratentorial Primitive Neuroectodermal Tumor
Cerebellar Astrocytoma, Childhood
Cerebral Astrocytoma, Childhood
Childhood Supratentorial Embryonal Tumor, Not Otherwise Specified
| Arm | Intervention/treatment |
|---|---|
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Experimental: Subjects that respond to Periactin
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.
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Drug: cyproheptadine hydrochloride
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 Name: Periactin |
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Experimental: Non-responders to Periactin- Megace Arm
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.
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Drug: cyproheptadine hydrochloride
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 Name: Periactin Drug: megestrol acetate 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 Name: Megace |
Primary Outcome Measures :
- 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 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 [ Time Frame: 4-8 weeks ]
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| Ages Eligible for Study: | 2 Years to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066248
Locations
Show 43 study locations
Sponsors and Collaborators
University of South Florida
National Cancer Institute (NCI)
Investigators
| Study Chair: | Jennifer L. Mayer, MD | H. Lee Moffitt Cancer Center and Research Institute |
Publications of Results:
| Responsible Party: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT00066248 |
| Other Study ID Numbers: |
SCUSF 0205 HLMCC-0205 ( Other Identifier: H. Lee Moffitt Cancer Center Research Base ) U10CA081920 ( U.S. NIH Grant/Contract ) SCUSF 0205 ( Other Identifier: SunCoast CCOP Research Base ) |
| First Posted: | August 7, 2003 Key Record Dates |
| Last Update Posted: | February 3, 2014 |
| Last Verified: | January 2014 |
Keywords provided by University of South Florida:
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cachexia unspecified childhood solid tumor 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 glioma hypothalamic glioma untreated childhood brain stem glioma |
untreated childhood visual pathway 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 |
Additional relevant MeSH terms:
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Lymphoma Neoplasms Leukemia Preleukemia Brain Neoplasms Nervous System Neoplasms Central Nervous System Neoplasms Myelodysplastic Syndromes Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Wasting Syndrome Syndrome Cachexia Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Emaciation Weight Loss Body Weight Changes |