Trial Information

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

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.