Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy
This study has been terminated.
(The study closed due to slow accrual.)
Sponsor:
Mayo Clinic
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01200602
First received: September 10, 2010
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
RATIONALE: Megestrol acetate may help improve appetite and lessen weight loss caused by cancer. PURPOSE: This clinical trial studies megestrol acetate in treating weight loss or anorexia in young patients with malignancies who are undergoing radiation therapy and/or chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Anorexia Weight Changes |
Drug: megestrol acetate Other: clinical observation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia |
Resource links provided by NLM:
Further study details as provided by Mayo Clinic:
Primary Outcome Measures:
- Proportion of Patients Who Maintain Weight or Experience Weight Gain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]A patient will be defined as "success" if he/she maintains or gains weight at the end if Initial Treatment compared with baseline of study entry.
Secondary Outcome Measures:
- BMI Trends [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Caloric Intake [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Weight Maintenance Over Time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Toxicity Profile [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0
| Enrollment: | 1 |
| Study Start Date: | March 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
|
Drug: megestrol acetate
Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day
Other Names:
|
|
Active Comparator: Arm B
Patients have clinical observation for weight loss and gain for 4 weeks.
|
Other: clinical observation
No treatment is given.
Other Name: observation
|
Detailed Description:
PRIMARY OBJECTIVES:Proportion of Patients Who Maintain Weight or Experience Weight Gain.
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Any pediatric patient with an underlying diagnosis of a malignancy (excluding hematological malignancies like leukemias and lymphomas)
- ≥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:
- Receiving tube feedings or parenteral nutrition
- 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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vilmarie Rodriguez, M.D., Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01200602 History of Changes |
| Other Study ID Numbers: | MC0896, NCI-2010-01938, 09-007533, MC0896 |
| Study First Received: | September 10, 2010 |
| Results First Received: | March 29, 2013 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Anorexia Body Weight Changes Weight Loss Signs and Symptoms, Digestive Signs and Symptoms Body Weight Megestrol Megestrol Acetate Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Appetite Stimulants Central Nervous System Stimulants Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013