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Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy

Primary Purpose

Anorexia, Weight Changes

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

megestrol acetate

clinical observation

About this trial

This is an interventional supportive care trial for Anorexia

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.

Patients have clinical observation for weight loss and gain for 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

BMI Trends

Caloric Intake

Weight Maintenance Over Time

Toxicity Profile

Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0

Full Information

NCT ID

NCT01200602

First Posted

September 10, 2010

Last Updated

October 29, 2015

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01200602

Brief Title

Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy

Official Title

A Randomized Megestrol Acetate/Placebo Controlled Trial in Pediatric Patients With Malignancies With Weight Loss/Anorexia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Terminated

Why Stopped

The study closed due to slow accrual.

Study Start Date

March 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anorexia, Weight Changes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

Patients have clinical observation for weight loss and gain for 4 weeks.

Intervention Type

Drug

Intervention Name(s)

megestrol acetate

Other Intervention Name(s)

BDH 1298, Maygace, Megace, Megestil, Niagestin, Pallace

Intervention Description

Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day

Intervention Type

Other

Intervention Name(s)

clinical observation

Other Intervention Name(s)

observation

Intervention Description

No treatment is given.

Primary Outcome Measure Information:

Title

Proportion of Patients Who Maintain Weight or Experience Weight Gain

Description

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.

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

BMI Trends

Time Frame

4 weeks

Title

Caloric Intake

Time Frame

4 weeks

Title

Weight Maintenance Over Time

Time Frame

4 weeks

Title

Toxicity Profile

Description

Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0

Time Frame

4 weeks

10. Eligibility

Sex

All

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vilmarie Rodriguez, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Megestrol Acetate in Treating Weight Loss or Anorexia in Young Patients With Malignancies Who Are Undergoing Radiation Therapy and/or Chemotherapy

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