NCT00031785

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2000

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

August 6, 2003

Completed
Last Updated

September 9, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

March 8, 2002

Last Update Submit

September 7, 2021

Conditions

AnorexiaCachexiaLung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerlimited stage small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung canceranorexiacachexia

Interventions

megestrol acetateDRUG
radiation therapyRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

MeSH Terms

Conditions

AnorexiaCachexiaLung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Megestrol AcetateRadiotherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightThinnessRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTherapeutics

Study Officials

  • Edward G. Shaw, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2002

First Posted

August 6, 2003

Study Start

September 1, 2000

Primary Completion

September 11, 2002

Study Completion

September 11, 2002

Last Updated

September 9, 2021

Record last verified: 2021-09

Locations

US(1)