Clinical trial · Interventional
Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
A Phase III, Double-Blind, Randomized Study Of The Effect Of Megestrol Acetate On Weight And Health Related Quality Of Life In Head And Neck Cancer Patients Receiving Radiation Therapy
NCT00006799CI-TRIAL-00053773completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss caused by cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss and improving quality of life in patients who have head and neck cancer and are undergoing radiation therapy.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anorexia | — | UNRESOLVED | — |
| Cachexia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| megestrol acetate | Drug | Megestrol | ALIAS |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven resected or unresectable stage I-IV epithelial head and neck cancer * Must be scheduled to receive a total dose of radiotherapy of at least 5,000 cGy in fraction sizes of no greater than 200 cGy * No distant metastases PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No history of congestive heart failure or thromboembolic events * No uncontrolled hypertension, active thromboembolic disease, or myocardial infarction within the past 3 months Pulmonary: * No history of pulmonary edema Other: * No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer * No feeding tube * No preexisting or uncontrolled diabetes with glycosylated hemoglobin greater than 10% * No history of Cushing's syndrome * No dietary restriction (salt, sugar, or lipid) * No serious medical or psychiatric illness that would preclude study * No significant ascites, pleural effusions, or edema that may inhibit oral food intake or invalidate weight measurements * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed Endocrine therapy: * At least 1 year since prior corticosteroids, estrogens, progestins, or any other steroid hormone * No concurrent estrogens or other progestins * Concurrent glucocorticoid replacement (10 mg of prednisone a day) allowed only if patient experiences moderate "stress" (e.g., infection, trauma, or fluid loss sufficient to require hospitalization and/or IV fluid replacement) Radiotherapy: * See Disease Characteristics * No prior radiotherapy to the head and neck Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.