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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Anorexia, Cachexia, Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Principal Investigator

Edward G. Shaw, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000069226

NCT ID:

NCT00031785

Start Date:

September 2000

Completion Date:

Related Keywords:

  • Anorexia
  • Cachexia
  • Lung Cancer
  • 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
  • Anorexia
  • Cachexia
  • Lung Neoplasms

Name

Location
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082