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

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedmegestrol acetate and radiation therapy

The study team can explain what participation involves.

Who it may be forAnorexia · Cachexia

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 9, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

Study overview

What this study is about

Purpose: Supportive Care
Study type: Interventional
Phase: Phase 3
Sponsor: Wake Forest University Health Sciences
Interventions being studied: Drug: megestrol acetate; Radiation: radiation therapy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 9, 2021. Always confirm current availability with the study team.

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