Anorexia, Weight Changes
Conditions
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.
Interventions
DRUGmegestrol acetate
Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day
OTHERclinical observation
No treatment is given.
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Who Maintain Weight or Experience Weight Gain | 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
| Measure | Time frame | Description |
|---|---|---|
| BMI Trends | 4 weeks | — |
| Caloric Intake | 4 weeks | — |
| Weight Maintenance Over Time | 4 weeks | — |
| Toxicity Profile | 4 weeks | Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0 |
Countries
United States
Participant flow
Recruitment details
One patient was accrued between March 2, 2011 and January 10, 2012. Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Participants by arm
| Arm | Count |
|---|---|
| Arm A Patients receive oral megestrol acetate 1-2 times daily for 4 weeks. | 0 |
| Arm B Patients have clinical observation for weight loss and gain for 4 weeks. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 4 weeks
Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Secondary
BMI Trends
Time frame: 4 weeks
Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Secondary
Caloric Intake
Time frame: 4 weeks
Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Secondary
Toxicity Profile
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
Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
Secondary
Weight Maintenance Over Time
Time frame: 4 weeks
Population: Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.