Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00031785
Collaborator
National Cancer Institute (NCI) (NIH)
25
1
24.3
1

Study Details

Study Description

Brief Summary

RATIONALE: Megestrol helps improve appetite. It is not yet known if megestrol is effective in limiting weight loss in patients who are undergoing radiation therapy.

PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in limiting weight loss in patients who are undergoing radiation therapy for lung cancer.

Condition or Disease Intervention/Treatment Phase
  • Drug: megestrol acetate
  • Radiation: radiation therapy
Phase 3

Detailed Description

OBJECTIVES:
  • Determine the effect of megestrol on weight in patients receiving radiotherapy for lung cancer.

  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to histology (non-small cell lung cancer vs small cell lung cancer), and type of treatment (radiotherapy vs radiotherapy and non-cisplatin-containing chemotherapy vs radiotherapy and cisplatin-containing chemotherapy). Patients are randomized to one of two treatment arms.

All patients undergo thoracic radiotherapy beginning on week 1 and continuing for a total of 5-7 weeks.

  • Arm I: Patients receive oral megestrol once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy.

  • Arm II: Patients receive oral placebo once daily beginning within the first 3 days of radiotherapy and continuing until 12 weeks after the completion of radiotherapy.

In both arms, quality of life is assessed at baseline, at the completion of radiotherapy, and at 4, 8, 12, 16, and 20 weeks after the completion of radiotherapy.

Patients are followed at 4 and 8 weeks.

PROJECTED ACCRUAL: A total of 98 patients (49 per treatment arm) will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
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 Lung Cancer Patients Receiving Thoracic Radiation Therapy
Actual Study Start Date :
Sep 1, 2000
Actual Primary Completion Date :
Sep 11, 2002
Actual Study Completion Date :
Sep 11, 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:
    No
    DISEASE CHARACTERISTICS:
    • Histologically confirmed lung cancer

    • Unresectable stage I-IIIB non-small cell lung cancer (NSCLC)

    • Resected stage I-IIIB NSCLC

    • Limited stage small cell lung cancer

    • Planned radiotherapy with a total dose of at least 5,000 cGy in fraction sizes of no greater than 200 cGy each

    • No distant metastases

    • No significant ascites, pleural effusions, or edema that would inhibit oral food intake or invalidate weight determinations

    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 uncontrolled hypertension

    • No active thromboembolic disease

    • No myocardial infarction within the past 3 months

    • No prior congestive heart failure or thromboembolic events

    Pulmonary:
    • No prior pulmonary edema
    Other:
    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No other malignancy within the past 3 years except curatively treated carcinoma in situ of the cervix or non-melanoma skin cancer

    • No uncontrolled diabetes with glycosylated hemoglobin greater than 10%

    • No Cushing's syndrome

    • No dietary restrictions (e.g., salt, sugar, or lipid)

    • No other serious medical or psychiatric illness that would preclude study

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • See Endocrine therapy
    Endocrine therapy:
    • At least 12 months since prior corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy

    • No concurrent corticosteroids, estrogens, progestins, or other steroid hormone except as antiemetic prior to chemotherapy

    Radiotherapy:
    • See Disease Characteristics

    • No prior radiotherapy to lung

    Surgery:
    • See Disease Characteristics

    • More than 14 days since prior surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Edward G. Shaw, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT00031785
    Other Study ID Numbers:
    • REBACDR0000069226
    • CCCWFU-98199
    • NCI-P02-0210
    First Posted:
    Aug 6, 2003
    Last Update Posted:
    Sep 9, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Wake Forest University Health Sciences
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 9, 2021