Megestrol in Treating Patients Who Are Undergoing Radiation Therapy for Lung Cancer - Full Text View

Sponsor:	Wake Forest University Baptist Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:	NCT00031785

Purpose

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	Intervention	Phase
Anorexia Cachexia Lung Cancer	Drug: megestrol acetate Radiation: radiation therapy	Phase III

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Weight Control

Drug Information available for: Megestrol acetate Megestrol

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Study Start Date:

September 2000

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031785

Locations

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

Sponsors and Collaborators

Wake Forest University Baptist Medical Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Edward G. Shaw, MD

Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00031785 History of Changes
Other Study ID Numbers:	CDR0000069226, CCCWFU-98199, NCI-P02-0210
Study First Received:	March 8, 2002
Last Updated:	August 20, 2009
Health Authority:	United States: Federal Government

Keywords provided by Wake Forest University Baptist Medical Center:

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

Additional relevant MeSH terms:

Anorexia
Cachexia
Lung Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

Megestrol Acetate
Megestrol
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Stimulants
Central Nervous System Stimulants
Physiological Effects of Drugs
Central Nervous System Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 09, 2012