Pulmonary Rehabilitation in Improving Lung Function in Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Chemoradiation

NCT02017925 | Withdrawn DMC

• 2 other identifiers: OSU-13044NCI-2013-02215
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized clinical trial studies pulmonary rehabilitation in improving lung function in patients with locally advanced non-small cell lung cancer undergoing chemoradiation. Individualized exercise rehabilitation programs may reduce breathing problems and improve quality of life in patients with non-small cell lung cancer. It is not yet known whether pulmonary rehabilitation is more effective when started during or after cancer treatment.

Conditions

Cachexia; Fatigue; Pulmonary Complications; Radiation Toxicity; Recurrent Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer

Keywords

Pulmonary Rehabilitation; Non-Small Cell Lung Cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• Percent improvement in the 6 minute walk from prior to post PR

  Either a two-sided t-test or a Wilcoxon-rank sum test will be used to test the difference in the improvement of the 6 minute walk depending on the distribution. This test will be used to compare the difference in improvement between PR during chemo-radiation of NSCLC patients and PR 8 weeks post chemo-radiation. Linear regression will be used to estimate which clinical characteristics and patient demographics are associated with improvement in 6 minute walk. The study population will be described using means and standard deviations or medians and the interquartile range.

  Baseline to up to 8 weeks

Secondary Outcomes (2)

• Percent improvement in the St. George Respiratory Questionnaire (SGRQ) score

  Baseline to up to 8 weeks

• Feasibility of the program, based on number of patients attending the sessions throughout the 8 weeks

  Up to 8 weeks

Study Arms (2)

Arm I (early intervention)

EXPERIMENTAL

Beginning within 2 weeks of starting chemoradiation, patients undergo an individualized rehabilitation program comprising aerobic exercise and strength training, including treadmill walking, stationary bicycle, NU-Step, upper body resistance training and breathing retraining, 3 times per week for 8 weeks (36 sessions).

Behavioral: exercise intervention; Procedure: pulmonary complications management/prevention; Procedure: quality-of-life assessment; Other: questionnaire administration

Arm II (late intervention)

EXPERIMENTAL

Beginning 1 month after completion of chemoradiation, patients undergo an individualized exercise rehabilitation program as in Arm I.

Behavioral: exercise intervention; Procedure: pulmonary complications management/prevention; Procedure: quality-of-life assessment; Other: questionnaire administration

Interventions

exercise intervention BEHAVIORAL

Undergo pulmonary rehabilitation

Arm I (early intervention); Arm II (late intervention)

pulmonary complications management/prevention PROCEDURE

Undergo pulmonary rehabilitation

Arm I (early intervention); Arm II (late intervention)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (early intervention); Arm II (late intervention)

questionnaire administration OTHER

Ancillary studies

Arm I (early intervention); Arm II (late intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been diagnosed with locally advanced unresectable NSCLC undergoing definite chemo-radiation with curative intent
• Patients must be able to sign informed consent
• Patients who qualify for pulmonary rehabilitation as part of the standard of care and are covered by medical insurance
• Patients must be able to ambulate a minimum of 100 feet prior to enrollment in pulmonary rehab
• Patients must be willing and able to travel to the pulmonary rehabilitation site at the Morehouse Medical Plaza

You may not qualify if:

• Tumor resection candidates
• If survival is deemed less than 6 months for any medical condition
• If they have angina or unstable coronary disease
• Congestive heart failure refractory to medical management
• Malignancy with bone instability
• Inmates

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Related Links

• The Jamesline

MeSH Terms

Conditions

Cachexia; Fatigue; Radiation Injuries; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Wounds and Injuries; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Patrick Nana-Sinkam, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 23, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04