- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006799
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the effect of megestrol on the weight of patients with head and neck cancer who are undergoing localized radiotherapy.
- Determine whether health-related quality of life improves in patients treated with megestrol.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of treatment (radiotherapy alone vs radiotherapy plus platinum-based chemotherapy vs radiotherapy plus non-platinum-based chemotherapy) and type of radiotherapy (primary vs postoperative). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive oral megestrol daily beginning within the first three days of radiotherapy and continuing during 5-7 weeks of radiotherapy and for 12 weeks after completion of radiotherapy.
- Arm II: Patients receive oral placebo daily according to the schedule for megestrol in arm I.
Quality of life is assessed at baseline, at completion of radiotherapy, and then at 4, 8, 12, and 16 weeks after completion of radiotherapy.
PROJECTED ACCRUAL: A total of 48-144 patients (24-72 per arm) will be accrued for this study within 14 months.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Kathryn M. Greven, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- untreated metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- stage III squamous cell carcinoma of the lip and oral cavity
- stage III basal cell carcinoma of the lip
- stage III verrucous carcinoma of the oral cavity
- stage III mucoepidermoid carcinoma of the oral cavity
- stage III adenoid cystic carcinoma of the oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV basal cell carcinoma of the lip
- stage IV verrucous carcinoma of the oral cavity
- stage IV mucoepidermoid carcinoma of the oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- stage III squamous cell carcinoma of the oropharynx
- stage III lymphoepithelioma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage IV lymphoepithelioma of the oropharynx
- stage III squamous cell carcinoma of the nasopharynx
- stage III lymphoepithelioma of the nasopharynx
- stage IV squamous cell carcinoma of the nasopharynx
- stage IV lymphoepithelioma of the nasopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the larynx
- stage III verrucous carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage IV verrucous carcinoma of the larynx
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III midline lethal granuloma of the paranasal sinus and nasal cavity
- stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- quality of life
- cachexia
- stage I squamous cell carcinoma of the lip and oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage I squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the larynx
- stage I squamous cell carcinoma of the nasopharynx
- stage I squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the nasopharynx
- stage II squamous cell carcinoma of the oropharynx
- stage III inverted papilloma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- anorexia
- stage I verrucous carcinoma of the oral cavity
- stage II verrucous carcinoma of the oral cavity
- stage I verrucous carcinoma of the larynx
- stage II verrucous carcinoma of the larynx
- stage I adenoid cystic carcinoma of the oral cavity
- stage I mucoepidermoid carcinoma of the oral cavity
- stage II adenoid cystic carcinoma of the oral cavity
- stage II mucoepidermoid carcinoma of the oral cavity
- stage I basal cell carcinoma of the lip
- stage II basal cell carcinoma of the lip
- stage I lymphoepithelioma of the nasopharynx
- stage II lymphoepithelioma of the nasopharynx
- stage I lymphoepithelioma of the oropharynx
- stage II lymphoepithelioma of the oropharynx
- stage I esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage I inverted papilloma of the paranasal sinus and nasal cavity
- stage I midline lethal granuloma of the paranasal sinus and nasal cavity
- stage II esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage II inverted papilloma of the paranasal sinus and nasal cavity
- stage II midline lethal granuloma of the paranasal sinus and nasal cavity
Additional Relevant MeSH Terms
- Metabolic Diseases
- Neoplasms
- Neoplasms by Site
- Signs and Symptoms, Digestive
- Nutrition Disorders
- Body Weight
- Body Weight Changes
- Emaciation
- Weight Loss
- Anorexia
- Head and Neck Neoplasms
- Wasting Syndrome
- Cachexia
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Hormonal
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral
- Contraceptive Agents, Female
- Contraceptives, Oral, Synthetic
- Contraceptives, Oral, Hormonal
- Central Nervous System Stimulants
- Appetite Stimulants
- Megestrol
- Megestrol Acetate
Other Study ID Numbers
- REBACDR0000068329
- CCCWFU-97300
- CCCWFU-0009
- CCCWFU-BG00-228
- NCI-P00-0174
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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