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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00031785
First received: March 8, 2002
Last updated: August 20, 2009
Last verified: August 2009
  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 3

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:


Further study details as provided by Wake Forest Baptist Health:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Baptist Health
Investigators
Study Chair: Edward G. Shaw, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
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 Baptist Health:
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
Body Weight
Body Weight Changes
Emaciation
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Signs and Symptoms
Signs and Symptoms, Digestive
Thoracic Neoplasms
Weight Loss
Megestrol
Megestrol Acetate
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Appetite Stimulants
Central Nervous System Agents
Central Nervous System Stimulants
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014