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
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
13 participants
Study completion date
September 6, 2002
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
untreated metastatic squamous neck cancer with occult primarymetastatic squamous neck cancer with occult primary squamous cell carcinomastage I squamous cell carcinoma of the lip and oral cavitystage I basal cell carcinoma of the lipstage I verrucous carcinoma of the oral cavitystage I mucoepidermoid carcinoma of the oral cavitystage I adenoid cystic carcinoma of the oral cavitystage II squamous cell carcinoma of the lip and oral cavitystage II basal cell carcinoma of the lipstage II verrucous carcinoma of the oral cavitystage II mucoepidermoid carcinoma of the oral cavitystage II adenoid cystic carcinoma of the oral cavitystage III squamous cell carcinoma of the lip and oral cavitystage III basal cell carcinoma of the lipstage III verrucous carcinoma of the oral cavitystage III mucoepidermoid carcinoma of the oral cavitystage III adenoid cystic carcinoma of the oral cavitystage IV squamous cell carcinoma of the lip and oral cavitystage IV basal cell carcinoma of the lipstage IV verrucous carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavitystage I squamous cell carcinoma of the oropharynxstage I lymphoepithelioma of the oropharynxstage II squamous cell carcinoma of the oropharynxstage II lymphoepithelioma of the oropharynxstage III squamous cell carcinoma of the oropharynxstage III lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxstage I squamous cell carcinoma of the nasopharynxstage I lymphoepithelioma of the nasopharynxstage II squamous cell carcinoma of the nasopharynxstage II lymphoepithelioma of the nasopharynxstage III squamous cell carcinoma of the nasopharynxstage III lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxstage I squamous cell carcinoma of the hypopharynxstage II squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxstage I squamous cell carcinoma of the larynxstage I verrucous carcinoma of the larynxstage II squamous cell carcinoma of the larynxstage II verrucous carcinoma of the larynxstage III squamous cell carcinoma of the larynxstage III verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxstage I squamous cell carcinoma of the paranasal sinus and nasal cavitystage I inverted papilloma of the paranasal sinus and nasal cavitystage I midline lethal granuloma of the paranasal sinus and nasal cavitystage I esthesioneuroblastoma of the paranasal sinus and nasal cavitystage II squamous cell carcinoma of the paranasal sinus and nasal cavitystage II inverted papilloma of the paranasal sinus and nasal cavitystage II midline lethal granuloma of the paranasal sinus and nasal cavitystage II esthesioneuroblastoma of the paranasal sinus and nasal cavitystage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage III inverted papilloma of the paranasal sinus and nasal cavitystage III midline lethal granuloma of the paranasal sinus and nasal cavitystage III esthesioneuroblastoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavityanorexiacachexiaquality of life
Interventions
megestrol acetateDrug
quality-of-life assessmentProcedure
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1082, United States
MeSH Terms
Conditions
AnorexiaCachexiaHead and Neck NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, Olfactory
Interventions
Megestrol Acetate
Condition Hierarchy (Ancestors)
Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightThinnessNeoplasms by Site
Study Officials
Kathryn M. Greven, MD
Wake Forest University Health Sciences
STUDY CHAIR
Enrollment
13 participants (actual enrollment reported by the registry).
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Source: ClinicalTrials.gov.
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