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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

This study has been terminated.
(The study closed due to slow accrual.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01200602
First Posted: September 13, 2010
Last Update Posted: November 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
  • Caloric Intake [ Time Frame: 4 weeks ]
  • Weight Maintenance Over Time [ Time Frame: 4 weeks ]
  • Toxicity Profile [ Time Frame: 4 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200602


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Vilmarie Rodriguez, M.D. Mayo Clinic
  More Information

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01200602     History of Changes
Other Study ID Numbers: MC0896
NCI-2010-01938 ( Registry Identifier: NCI-CTRP )
09-007533 ( Other Identifier: Mayo Clinic IRB )
MC0896 ( Other Identifier: Mayo Clinic Cancer Center )
First Submitted: September 10, 2010
First Posted: September 13, 2010
Results First Submitted: March 29, 2013
Results First Posted: May 24, 2013
Last Update Posted: November 25, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Body Weight
Weight Loss
Anorexia
Body Weight Changes
Signs and Symptoms
Signs and Symptoms, Digestive
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants