search
Back to results

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

Primary Purpose

Anorexia, Cachexia, Lung Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
megestrol acetate
radiation therapy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anorexia focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, limited stage small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, anorexia, cachexia

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Comprehensive Cancer Center at Wake Forest University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00031785
Brief Title
Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2000 (Actual)
Primary Completion Date
September 11, 2002 (Actual)
Study Completion Date
September 11, 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia, Cachexia, Lung Cancer
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, limited stage small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, anorexia, cachexia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
megestrol acetate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward G. Shaw, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1082
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs