Clinical trial NCT00031785: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center at Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Edward G. Shaw, MD
role: STUDY_CHAIR
References: