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:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01200602
First received: September 10, 2010
Last updated: March 29, 2013
Last verified: March 2013
  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:
  • BDH 1298
  • Maygace
  • Megace
  • Megestil
  • Niagestin
  • Pallace
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200602

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Vilmarie Rodriguez, M.D. Mayo Clinic
  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 July 29, 2014