Aerobic Exercise and Tai-chi Interventions for Improving Survival in Lung Cancer Patients

Lung Cancer Patients Clinical Trial

Official title: Improving Survival in Lung Cancer Patients: A Randomized Controlled Trial of Aerobic Exercise and Tai-chi Interventions

Status Completed

Clinical Trial Summary

This proposed study aims to examine the effect of classical aerobic exercise or tai-chi on 1-year survival rate of lung cancer patients compared to usual care, as a primary outcome of this study. To understand the hypothesized outcomes of improved survival of lung cancer patients through physical exercise or tai-chi practice intervention, we will examine the changes in some subjective psychosocial outcomes and objective biomarkers that may be associated with the survival of cancer patients, as the secondary outcome of this study. Those biomarkers will be in following aspects: 1.) circadian rhythm, 2.) cardio-respiratory fitness, and 3.) immune functions. Secondary outcome measures include: quality of life, psychological distress, quality of sleep, fatigue, level of physical activity, circadian rhythms, cardio-respiratory fitness, physical functioning tests and immune function. The pilot study aims to assess the feasibility and acceptability of the trial so that the main study will have a higher chance of success.

Clinical Trial Description

Lung cancer is one of the commonest cancers around the world. The current prognosis for lung cancer is poor, with a 1-year survival rate of only 42%. Thus, lung cancer imposes a substantial health burden on patients and society both locally and world widely. On top of the classical clinical therapies, additional approaches that could result in survival benefit are needed.

Previous studies, including our own, have shown that physical exercise, such as aerobic walking, improves lung cancer patient's physical fitness particularly cardiovascular fitness, circadian rhythm and immune function. Another popular mode of exercise in Chinese population is tai-chi. With emphasis on breathing and concentration, tai-chi exhibits extra benefits for stress-relieving and psychological well-being. Those benefits of exercise have long been implicated for better survival of cancer patients. The promising benefits of aerobic exercise or tai-chi, as non-pharmacological interventions, urge for need of rigorous evidence on the effectiveness of these interventions in improving survival outcomes. However, to date, there has been no report from a randomized controlled trial (RCT) to study the effect of aerobic exercise or tai-chi on survival of lung cancer patients.

This proposed research is designed to conduct a three-arm RCT comparing aerobic exercise, tai-chi to usual care in non-small cell lung cancer patients. Recruited participants will be randomised into three groups: 1) a 12-week aerobic exercise group, 2) a 12-week tai-chi program group, and 3) a self-management control group. Aerobic exercise and tai-chi program will be conducted by certificated coaches. Life-long adherence to the practice in intervention groups is encouraged.

Through this project we aim to evaluate if 1) aerobic exercise or 2) tai-chi intervention increases survival (measured by 1-year survival rate) in lung cancer patients compared to control, as the primary outcome of this study. We shall also examine if tai-chi practice can provide similar survival benefits compared with ordinary exercise. Using biomarkers including circadian rhythm, cardio-respiratory fitness, and immune function further provides objective measures for bio-physiological effectiveness of the interventions. The associations of those biological measures and psycho-social status with survival outcomes will be further explored.

Findings of this study will provide crucial information on the evidence-based practice by physical exercise or tai-chi to improve survival of lung cancer patients. This study will also have far-reaching significance in providing important scientific evidence to policymakers to integrate physical activity into routine clinical management as an add-on treatment for lung cancer patients in Hong Kong.

The pilot study aims to assess the feasibility and acceptability (such as attendance, drop out, satisfaction) of the trial so that the main study will have a higher chance of success. ;

Related Conditions & MeSH terms

• Lung Cancer Patients
• Lung Neoplasms

• NCT number: NCT03482323
• Study type: Interventional
• Source: The University of Hong Kong
• Status: Completed
• Phase: N/A
• Start date: May 10, 2018
• Completion date: August 31, 2019