NCT00031785已完成3 期
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
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Performance status:
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •Not specified
- •Not specified
- •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
- •No prior pulmonary edema
- •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
- •See Disease Characteristics
- •More than 14 days since prior surgery
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Megestrol to Limit Weight Loss and Improve Quality of Life in Treating Patients With Head and Neck CancerAnorexiaCachexiaHead and Neck CancerQuality of LifeNCT00006799Wake Forest University Health Sciences13
已完成
不适用
A Randomized Clinical Trial of Megestrol Acetate as an Appetite Stimulant in Malnourished Children With CancerMalnourished Children With CancerNCT00439101University of British Columbia26
终止
2 期
Study to Evaluate the Effect of Megestrol Acetate in Weight Loss in Dementia PatientsDementiaNCT00503516Rottapharm Spain39
已完成
3 期
A Study Comparing Megestrol Acetate at 800 mg/Day, and Placebo in AIDS Patients With Anorexia and CachexiaCachexiaHIV InfectionsAnorexiaNCT00002067Bristol-Myers Squibb
已完成
2 期
Study to Evaluate the Effect of Megestrol Acetate in Severe Chronic Obstructive Pulmonary Disease With Loss of WeightChronic Obstructive Pulmonary DiseaseNCT00507949Rottapharm Spain40