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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01938 | Registry Identifier | NCI-CTRP | |
| 09-007533 | Other Identifier | Mayo Clinic IRB | |
| MC0896 | Other Identifier | Mayo Clinic Cancer Center |
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The study closed due to slow accrual.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Patients receive oral megestrol acetate 1-2 times daily for 4 weeks. |
|
| Arm B | Active Comparator | Patients have clinical observation for weight loss and gain for 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| megestrol acetate | Drug | Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI Trends | 4 weeks | |
| Caloric Intake | 4 weeks | |
| Weight Maintenance Over Time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vilmarie Rodriguez, M.D. | Mayo Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm A | Patients receive oral megestrol acetate 1-2 times daily for 4 weeks. |
| FG001 | Arm B | Patients have clinical observation for weight loss and gain for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| clinical observation | Other | No treatment is given. |
|
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| 4 weeks |
| Toxicity Profile | Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0 | 4 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Patients receive oral megestrol acetate 1-2 times daily for 4 weeks. |
| BG001 | Arm B | Patients have clinical observation for weight loss and gain for 4 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Mean | Standard Deviation | years | ||||||||||||||
| Sex: Female, Male | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Count of Participants | Participants |
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| Region of Enrollment | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | 4 weeks |
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| Secondary | BMI Trends | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | 4 weeks |
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| Secondary | Caloric Intake | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | 4 weeks |
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| Secondary | Weight Maintenance Over Time | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | 4 weeks |
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| Secondary | Toxicity Profile | Number of patients with grade 3+ non-hematologic adverse events using Common Toxicity Criteria for Adverse Effects (CTCAE) v.4.0 | Since only one patient was accrued, patient confidentiality prevents the reporting of this patient. | Posted | 4 weeks |
|
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4 weeks
Since only one patient was accrued, patient confidentiality prevents the reporting of this patient.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Patients receive oral megestrol acetate 1-2 times daily for 4 weeks. | 0 | 0 | 0 | 0 | ||
| EG001 | Arm B | Patients have clinical observation for weight loss and gain for 4 weeks. | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vilmarie Rodriguez, MD | Mayo Clinic | 507-284-2695 | rodriguez.vilmarie@mayo.edu |
| ID | Term |
|---|---|
| D000855 | Anorexia |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| D057832 | Watchful Waiting |
| D019370 | Observation |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D008722 | Methods |
| D008919 | Investigative Techniques |
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