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

NCT01200602 | Terminated Phase 2 Results DMC

• 3 other identifiers: MC0896NCI-2010-0193809-007533
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia; Weight Changes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• BMI Trends

  4 weeks

• Caloric Intake

  4 weeks

• Weight Maintenance Over Time

  4 weeks

• Toxicity Profile

  4 weeks

Study Arms (2)

Arm A

EXPERIMENTAL

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

Drug: megestrol acetate

Arm B

ACTIVE COMPARATOR

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

Other: clinical observation

Interventions

megestrol acetate DRUG

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

Also known as: BDH 1298, Maygace, Megace, Megestil, Niagestin, Pallace

Arm A

clinical observation OTHER

No treatment is given.

Also known as: observation

Arm B

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Anorexia; Body Weight Changes

Interventions

Megestrol Acetate; Watchful Waiting; Observation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Methods; Investigative Techniques

Results Point of Contact

• Title: Vilmarie Rodriguez, MD
• Organization: Mayo Clinic

rodriguez.vilmarie@mayo.edu

507-284-2695

Study Officials

• Vilmarie Rodriguez, M.D.

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2010
• First Posted: September 13, 2010
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: November 25, 2015
• Results First Posted: May 24, 2013

Record last verified: 2015-10

Locations

US (1)