Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
NCT ID: NCT01200602
Last Updated: 2015-11-25
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2011-03-31
2012-01-31
Brief Summary
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Detailed Description
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SECONDARY OBJECTIVES:BMI Trends, Caloric Intake, Weight Maintenance Over Time, Toxicity Profile as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.
OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients receive oral megestrol acetate 1-2 times (10 mg/kg dose if once daily or 5 mg/kg dose if twice daily) daily for 4 weeks. ARM B (control): Patients are observed for weight loss and gain for 4 weeks. After completion of study treatment, patients are followed up for 12 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm A
Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
megestrol acetate
Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day
Arm B
Patients have clinical observation for weight loss and gain for 4 weeks.
clinical observation
No treatment is given.
Interventions
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megestrol acetate
Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day
clinical observation
No treatment is given.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥5% weight loss from diagnosis of primary malignancy (must be currently on chemotherapy and/or radiation therapy or scheduled to receive cancer therapy OR ≥5% weight loss following bone marrow transplant (autologous or allogeneic blood/bone marrow) and not actively receiving corticosteroid therapy
* Negative pregnancy test done =\< 7 days prior to registration for women of childbearing potential only
Exclusion Criteria
* Evidence of ascites
* Current (within the past 28 days) or planned treatment with adrenal steroids (short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis), androgens, progestational agents, or appetite stimulants (e.g., dronabinol)
* Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (\> 5 episodes/week)
* History of unresectable brain tumor or cancer metastatic to the brain
* History of thromboembolic disease
* Insulin-requiring diabetes
* Congestive heart failure and/or uncontrolled hypertension
* Anticoagulation
* Previous history of thrombosis (personal and immediate family)
* Concurrent corticosteroid therapy (except as an antiemetic)
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Vilmarie Rodriguez, M.D.
Role: STUDY_CHAIR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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NCI-2010-01938
Identifier Type: REGISTRY
Identifier Source: secondary_id
09-007533
Identifier Type: OTHER
Identifier Source: secondary_id
MC0896
Identifier Type: OTHER
Identifier Source: secondary_id
MC0896
Identifier Type: -
Identifier Source: org_study_id