Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer
This study has been completed.
Sponsor:
Wake Forest University Baptist Medical Center
Collaborator:
Information provided by:
Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:
NCT00006799
First received: December 6, 2000
Last updated: August 20, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anorexia Cachexia Head and Neck Cancer Quality of Life |
Drug: megestrol acetate Procedure: quality-of-life assessment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| Official Title: | 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Benign Tumors
Cancer
Head and Neck Cancer
Tonsils and Adenoids
Weight Control
Drug Information available for:
Megestrol acetate
U.S. FDA Resources
Further study details as provided by Wake Forest University Baptist Medical Center:
| Study Start Date: | October 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006799
Locations
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
Sponsors and Collaborators
Wake Forest University Baptist Medical Center
Investigators
| Study Chair: | Kathryn M. Greven, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006799 History of Changes |
| Other Study ID Numbers: | CDR0000068329, CCCWFU-97300, CCCWFU-0009, CCCWFU-BG00-228, NCI-P00-0174 |
| Study First Received: | December 6, 2000 |
| Last Updated: | August 20, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by Wake Forest University Baptist Medical Center:
|
untreated metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage I squamous cell carcinoma of the lip and oral cavity stage I basal cell carcinoma of the lip stage I verrucous carcinoma of the oral cavity stage I mucoepidermoid carcinoma of the oral cavity stage I adenoid cystic carcinoma of the oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage II basal cell carcinoma of the lip stage II verrucous carcinoma of the oral cavity stage II mucoepidermoid carcinoma of the oral cavity stage II adenoid cystic carcinoma of the oral cavity 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 I squamous cell carcinoma of the oropharynx stage I lymphoepithelioma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage II lymphoepithelioma of the oropharynx 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 |
Additional relevant MeSH terms:
|
Anorexia Cachexia Head and Neck Neoplasms Signs and Symptoms, Digestive Signs and Symptoms Emaciation Weight Loss Body Weight Changes Body Weight Neoplasms by Site Neoplasms Megestrol Megestrol Acetate |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Appetite Stimulants Central Nervous System Stimulants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 22, 2013