Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck Cancer

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00006799

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

23.2

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Anorexia Cachexia Head and Neck Cancer Quality of Life	Drug: megestrol acetate Procedure: quality-of-life assessment	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Masking:

Double (Participant, Investigator)

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

Actual Study Start Date :

Oct 1, 2000

Actual Primary Completion Date :

Sep 6, 2002

Actual Study Completion Date :

Sep 6, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)