Suspended

A Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy

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What is being tested

educational intervention

+ supervised exercise program

Other
Who is being recruted

Lung Diseases+4

+ Lung Neoplasms

+ Neoplasms

See all eligibility criteria
How is the trial designed

Interventional
Study Start: September 2004
See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2004

Actual date on which the first participant was enrolled.

OBJECTIVES: * Compare improvement in physiologic function, in terms of exercise tolerance, in patients with inoperable locally advanced lung cancer undergoing chemoradiotherapy and randomized to pulmonary rehabilitation comprising education with vs without supervised exercise training. * Compare the health-related quality of life, in terms of multidimensional functioning and patient perception of respiratory difficulties, in patients undergoing these pulmonary rehabilitation interventions. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to Zubrod performance status (0-1 vs 2); FEV_1 (≥ 70% of predicted vs < 70% of predicted); and smoking status\* (never smoked or former smoker vs current smoker). Approximately 20 weeks into treatment on SWOG-S0023, patients are randomized to 1 of 2 intervention arms. NOTE: \* Never smoked is defined as < 100 cigarettes in a lifetime and former smoker is defined as no smoking for ≥ 1 year. * Arm I: Patients participate in a supervised structured exercise program (i.e., walking on a treadmill OR using a stationary exercise bicycle) 3 times a week for 12 weeks. Patients also receive educational materials on how to improve breathing and conserve energy. * Arm II: Patients receive educational materials as in arm I. In both arms, patients undergo exercise testing using 6-minute walks to measure exercise tolerance at initial evaluation (after randomization but prior to intervention), 12 weeks, and then at 6 and 9 months. In both arms, intervention continues in the absence of disease progression or the development of other medical conditions that would preclude study participation. Quality of life is assessed at baseline, 12 weeks, and then at 6 and 9 months. PROJECTED ACCRUAL: A total of 164 patients (82 per treatment arm) will be accrued for this study.

Official TitleA Randomized Trial Assessing the Effects of Exercise on Patients With Locally Advanced Lung Cancer Undergoing Curative Intent Combined Modality Therapy 
NCT00090961
Principal SponsorSWOG Cancer Research Network
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed single, primary bronchogenic lung cancer * Inoperable, locally advanced disease (unresectable stage IIIA OR stage IIIB disease) * The following histologies are eligible: * Adenocarcinoma * Large cell carcinoma * Squamous cell carcinoma * Non-lobar and non-diffuse bronchoalveolar carcinoma * Small cell lung cancer * Must have received chemotherapy (platinum based) and radiotherapy for locally advanced unresectable lung cancer * Must have achieved a complete response, partial response, or stable disease after treatment PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No acute EKG changes, arrhythmia, or other cardiac abnormality that would preclude study participation * No uncontrolled cardiac disease * No recent myocardial infarction Pulmonary * Any FEV_1 level by pulmonary function testing Other * Willing to participate in 12-week long exercise program * Chemotherapy-induced neuropathy ≤ grade 2 * No uncontrolled diabetes mellitus * No other medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
A 12-week supervised exercise program consisting of 3 days a week on a stationary bike or treadmill. In addition, at the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.

Group II

At the time of enrollment patients are provided educational materials focusing on breathing and energy conservation.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 59 locations

Suspended

Poudre Valley Hospital

Fort Collins, United StatesSee the location
Suspended

Decatur Memorial Hospital Cancer Care Institute

Decatur, United States
Suspended

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, United States
Suspended

Regional Cancer Center at Memorial Medical Center

Springfield, United States
Suspended59 Study Centers