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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01200602
Other study ID # MC0896
Secondary ID NCI-2010-0193809
Status Terminated
Phase Phase 2
First received September 10, 2010
Last updated October 29, 2015
Start date March 2011
Est. completion date January 2012

Study information

Verified date October 2015
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date January 2012
Est. primary completion date November 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
megestrol acetate
Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day
Other:
clinical observation
No treatment is given.

Locations

Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)

Lead Sponsor Collaborator
Mayo Clinic National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of Patients Who Maintain Weight or Experience Weight Gain 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. 4 weeks No
Secondary BMI Trends 4 weeks No
Secondary Caloric Intake 4 weeks No
Secondary Weight Maintenance Over Time 4 weeks No
Secondary Toxicity Profile Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0 4 weeks Yes
See also
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