Clinical trial NCT03482323: Aerobic Exercise and Tai-chi Interventions for Improving Survival in Lung Cancer Patients
Official title: Improving Survival in Lung Cancer Patients: A Randomized Controlled Trial of Aerobic Exercise and Tai-chi Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer Patients
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants will be randomised into equally sized arms; tai-chi classes, exercise classes, or control.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who are diagnosed of stage IIIB, or IV non-small-cell lung cancer confirmed by pathology
2. Patients are not currently engaged in other research or participant in any other exercise or mind-body classes
3. Patients aged 18 years old, or above
4. Patients who can communicate in Cantonese, Mandarin or English
5. Patients with no other cancer diagnosis within the previous 1 year
6. Patients report not doing regular exercises (defined \<150 min of moderate-intensity exercise weekly) in daily living, but are able to attend either exercise or tai-chi classes at scheduled times
7. Patients being conscious and alert.

Exclusion Criteria:

Patients suffering from a diagnosed active neurological, substance abuse and /or psychiatric disorders (i.e. depression, chronic insomnia) will be excluded.

Primary outcomes:
measure: One-year survival rate
timeFrame: One year
Secondary outcomes:
measure: Levels of physical activity
timeFrame: Baseline, 12 weeks, 6 months and one year
measure: Circadian rhythms- cortisol and melatonin rhythms
timeFrame: Baseline and one year
measure: Cardio-respiratory fitness- 6-minute walking test
timeFrame: Baseline, 12 weeks, 6 months and one year
measure: Physical functioning- timed up and go test, sit to stand test, single leg standing test, Get Active Questionnaire
timeFrame: Baseline, 12 weeks, 6 months and one year
measure: Immune functions- cytotoxic activity of natural killer (NK) cells, and spontaneous or phytohemagglutinin (PHA)-stimulated T-lymphocyte proliferation
timeFrame: Baseline and one year
measure: Health-related quality of Life- European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire and the corresponding lung cancer-specific module
timeFrame: Baseline, 12 weeks, 6 months and one year
measure: Psychological Distress- Hospital Anxiety and Depression Score
timeFrame: Baseline, 12 weeks, 6 months and one year
measure: Quality of Sleep (Subjective)- Pittsburgh Sleep Quality Index
timeFrame: Baseline, 12 weeks, 6 months and one year
measure: Fatigue- Brief Fatigue Inventory
timeFrame: Baseline, 12 weeks, 6 months and one year
measure: Quality of Sleep (Objective)- Actigraph
timeFrame: Baseline, 12 weeks, 6 months and one year
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Chia-Chin Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fong DY, Ho JW, Hui BP, Lee AM, Macfarlane DJ, Leung SS, Cerin E, Chan WY, Leung IP, Lam SH, Taylor AJ, Cheng KK. Physical activity for cancer survivors: meta-analysis of randomised controlled trials. BMJ. 2012 Jan 30;344:e70. doi: 10.1136/bmj.e70.
citation: Mustian KM, Katula JA, Gill DL, Roscoe JA, Lang D, Murphy K. Tai Chi Chuan, health-related quality of life and self-esteem: a randomized trial with breast cancer survivors. Support Care Cancer. 2004 Dec;12(12):871-6. doi: 10.1007/s00520-004-0682-6. Epub 2004 Sep 30.
citation: Sui X, Lee DC, Matthews CE, Adams SA, Hebert JR, Church TS, Lee CD, Blair SN. Influence of cardiorespiratory fitness on lung cancer mortality. Med Sci Sports Exerc. 2010 May;42(5):872-8. doi: 10.1249/MSS.0b013e3181c47b65.
citation: Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Effect of walking on circadian rhythms and sleep quality of patients with lung cancer: a randomised controlled trial. Br J Cancer. 2016 Nov 22;115(11):1304-1312. doi: 10.1038/bjc.2016.356. Epub 2016 Nov 3.
citation: Chen HM, Tsai CM, Wu YC, Lin KC, Lin CC. Randomised controlled trial on the effectiveness of home-based walking exercise on anxiety, depression and cancer-related symptoms in patients with lung cancer. Br J Cancer. 2015 Feb 3;112(3):438-45. doi: 10.1038/bjc.2014.612. Epub 2014 Dec 9.
citation: Cheung DST, Takemura N, Lam TC, Ho JCM, Deng W, Smith R, Yan Y, Lee AWM, Lin CC. Feasibility of Aerobic Exercise and Tai-Chi Interventions in Advanced Lung Cancer Patients: A Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211033352. doi: 10.1177/15347354211033352.
citation: Takemura N, Cheung DST, Fong DYT, Lee AWM, Lam TC, Ho JC, Kam TY, Chik JYK, Lin CC. Relationship of subjective and objective sleep measures with physical performance in advanced-stage lung cancer patients. Sci Rep. 2021 Aug 26;11(1):17208. doi: 10.1038/s41598-021-96481-7.