Lung NeoplasmsNCT04185467
Lung Cancer Rehabilitation After Medical Treatment
A study testing Intervention (rehabilitation exercise) in people with Lung Neoplasms, run by Nantong University at 2 sites in China.
Trial summary
Lung cancer is the leading cause of cancer death worldwide and associated with high disease burden, symptoms and poor health-related quality of life (HRQoL). Lung cancer is the most commonly diagnosed type of cancer in China (with rates rising due to the smoking incidence) and is the leading cause of cancer-related… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- Intervention (rehabilitation exercise)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 5 Dec 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with non-small cell lung cancer (NSCLC) 4-12 weeks following completion of treatment (surgery, chemotherapy, radiotherapy, immunotherapy);
- Physician/doctor approval;
- Physician rated life expectancy greater than 6 months;
- Informed consent;
- Eastern Cooperate Oncology Group (ECOG) performance status of 0-2 at study entry;
- Not meeting physical activity/exercise guidelines.
Who cannot join
- Unstable psychiatric/cognitive disorder;
- Comorbidity preventing exercise;
- ECOG performance status of 3 or 4 at study entry.
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
the Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226000
About this study
Official title: The Effectiveness of Rehabilitation for Patients With Lung Cancer in China: a Randomised Controlled Trial
Lung cancer is the leading cause of cancer death worldwide and associated with high disease burden, symptoms and poor health-related quality of life (HRQoL). Lung cancer is the most commonly diagnosed type of cancer in China (with rates rising due to the smoking incidence) and is the leading cause of cancer-related death. The burden is on patients, families, the healthcare system and society, and will continue to rise into the future. The full impact of this in China has not yet occurred. New strategies are urgently required to improve survivorship. This multi-site, assessor blinded, two-arm superiority randomised controlled trial, conducted at two hospitals in China, aims to test the effect of exercise rehabilitation, compared to usual care (no exercise rehabilitation) on HRQoL and functional outcomes in 150 patients treated for lung cancer. The primary hypothesis is that exercise rehabilitation will be superior to usual care, in improving HRQoL at 12-weeks (post program). Secondary aims include measuring the effectiveness of exercise rehabilitation, compared to usual care on function, physical activity, symptoms, mood, sleep and program costs. Faecal samples (500mg) will be collected before and after the intervention.
Read the detailed description
Lung cancer is the leading cause of cancer death worldwide and associated with high disease burden, symptoms and poor health-related quality of life (HRQoL). Lung cancer is the most commonly diagnosed type of cancer in China (with rates rising due to the smoking incidence) and is the leading cause of cancer-related death. The burden is on patients, families, the healthcare system and society, and will continue to rise into the future. The full impact of this in China has not yet occurred. New strategies are urgently required to improve survivorship. This multi-site, assessor blinded, two-arm superiority randomized controlled trial, conducted at two hospitals in China, aims to test the effect of exercise rehabilitation, compared to usual care (no exercise rehabilitation) on HRQoL and outcomes including physical function in 150 patients treated for lung cancer. The primary hypothesis is that exercise rehabilitation will be superior to usual care, in improving HRQoL at 12-weeks (post program). Secondary aims include include measuring the effectiveness of exercise rehabilitation, compared to usual care on function, physical activity, symptoms, mood, sleep and program costs.
One hundred and fifty patients with stage I-IIIA non-small cell lung cancer (NSCLC) 4-12 weeks following completion of treatment (including surgery with or without adjuvant therapy) and life expectancy greater than 6 months will be recruited from the affiliated hospital of Nantong University and the first affiliated hospital of Nanjing Medical University. At recruitment participants provide written informed consent, complete baseline assessment and to ensure concealment of allocation participants will be randomly allocated off-site to one of two arms (1:1 ratio). The intervention programs start following randomization and will continue for 12 weeks duration. Trained physiotherapists will provide the intervention. Patients in both arms will receive usual medical, physiotherapy and nursing care according to usual protocols. This does not involve exercise rehabilitation or advice. Additionally patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking) and resistance training and 30 minutes of 8 style Tai Chi). Participants will be advised to walk on days of non-attendance - this will be individualized with the aim to have participants increase to 30 minutes walking per day. Assessments will be conducted at baseline and then by blinded assessors at 12 weeks and 6 months post-baseline. Survival will be followed-up and censored at 1 year. This important study brings together a strong collaborative research team spanning China and Australia, involving medical doctors, physiotherapists and academics. The topic is important, novel and will generate clinically meaningful research for an international audience, aiming to improve the survivorship quality of patients with lung cancer.
The gut microbiome is a source of potentially disease-modifying bioactive metabolites and has recently been suggested to contribute to the pathogenesis of a variety of disorders. Therefore, we will study the gut microbiota and metabolites of the participants in order to identify potential the biomarkers for the clinical outcomes. Fresh faecal samples will be collected from all individuals before group assignment and after the completion of the program. The written informed consent will be provided by the participants.
Specifically, faecal samples (500mg) will be collected from participants who are free from gastrointestinal conditions, with no antibiotic exposure in the 28 days prior to sample collection. 'Snap' frozen samples will be stored at -80°C until the time of DNA extractions, 16S rDNA sequencing, and mass spectrometry analysis of the faecal metabolites. The distribution of gut microbiota before and after exercise will be compared and analyzed to obtain the species of bacterial flora that changed significantly after exercise. Moreover, the gut metabolites that changed significantly before and after exercise will be used to explore the biomarkers for the curative effect of rehabilitation exercise, as well as their relationships with the differentially distributed gut microbiota.
- Conditions
- Lung Neoplasms
- Being tested
- Intervention (rehabilitation exercise)
- Keywords
- lung cancer, exercise, rehabilitation, Tai Chi, health-related quality of life
- Medical subject headings
- Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention (rehabilitation exercise)Other
Patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking), resistance training and 30 minutes of 8 style Tai Chi. Participants will be advised to walk on days of non-attendance - this will be individualised with the aim to have participants increase to 30 minutes walking per day.
| Study group | Role | What they receive |
|---|---|---|
| Usual care(both arms) | No intervention | Usual care (both arms): Patients in both arms will receive usual medical, physiotherapy and nursing care according to usual protocols. This does not involve exercise rehabilitation or advice. |
| Intervention (exercise rehabilitation) | Experimental | Patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking), resistance training and 30 minutes of 8 style Tai Chi. Participants will be advised to walk on days of non-attendance - this will be individualised with the aim to have participants increase to 30 minutes walking per day. Receives: Other: Intervention (rehabilitation exercise) |
What is being measured
The primary outcome is the main question the study is designed to answer.
European Organization for the Research and Treatment of Cancer questionnaire (EORTC QLQ-C30-LC13)
HRQoL will be assessed with the European Organization for the Research and Treatment of Cancer questionnaire (EORTC QLQ-C30-LC13) at baseline, 12 weeks and 6 months post-baseline. Score ranges from 0~100.For functional domains and global health status/quality of life scale, higher score means better status. While for symptom domains and single-items, lower scores represent less symptoms.
Measured: The primary time point is the change from baseline to 12 weeks. This outcome will also be measured at 6 months post-baseline.
Secondary outcomes (11)
Functional Exercise Capacity
All participants will complete a Incremental Shuttle Walking Test following published guidelines.
Measured: 1) baseline, 2) 12 week, and 3) 6 months post-baseline.
Seven-day Physical Activity
Will be measured objectively using an pedometer at baseline, 12 weeks and 6 months post-baseline. It is worn for 7 consecutive days and a minimum of four full days (8 hours/day) is required for valid analyses.
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Grip strength
A hand held dynamometry manual muscle test is a common, simple measurement of strength and has been used in many patient populations including cancer and is reliable and sensitive to change. We will measure hand grip strength bilaterally
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
30-Second Chair Stand
To test leg strength and endurance. A below average score indicates a risk for falls.
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
International physical activity questionnaire(IPAQ)
The International Physical Activity Questionnaire (IPAQ) scores are categorised as high/moderate (meeting PA guidelines) or low (not meeting PA guidelines) and as a continuous energy expenditure score (metabolic equivalent of task (MET) minutes per week). Higher scores indicate increased PA.
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Self-Rating Anxiety Scale(SAS)
To test the anxiety level of the patients. It has 20 items and are four-point scale(rated 1-4), some of the items are reversely scored. Score ranges from 0~100, higher score means worse anxiety status.
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Self-Rating Depression Scale(SDS)
To test the depression level of the patients. It has 20 items and are four-point scale(rated 1-4), some of the items are reversely scored. Score ranges from 0~100, higher score means worse depression status.
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Pittsburgh Sleep Quality Index(PSQI)
Pittsburgh Sleep Quality Index(PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores. The sum of scores for these seven components yields one global score, and the higher score means the worse sleep quality. Score ranges from 0~21, higher score means worse sleep quality.
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
MD Anderson Symptom Inventory-lung cancer (MDASI-LC)
To evaluate to the severity and interference of the symptom in participants.The MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) will be used to measure symptom severity and distress. The symptom severity component comprises 13 core and three lung cancer specific items, measured on a 0-10 numerical rating scale. The average score is reported, with higher scores indicating worse symptoms. The MCID in lung cancer has been reported as being between 0.98 to 1.21 points
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Australia-modified Karnofsky Performance Status(AKPS)
To evaluate the performance of the whole well-being of the participants. Score ranges from 0~100, higher score means better status.
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
European quality of life 5-dimension 5-level(EQ-5D-5L)
European quality of life 5-dimension 5-level(EQ-5D-5L) is a family of instruments to describe and value health. It comprises a short descriptive system questionnaire and a visual analogue scale that are cognitively undemanding. A value set provides values(weights) for each health state description according to the preferences of the general population of a country/region.
Measured: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start5 Dec 2019
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Why it stopped: The coronavirus broke out in China at the end of 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lung NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Design: Two-site, assessor blinded, two-arm superiority randomised controlled trial. Setting: Participant recruitment from the affiliated hospital of Nantong University and the first affiliated hospital of Nanjing Medical University Procedure: Randomisation: Randomisation list devised by independent statistician; carried out using the REDCap randomisation function to ensure allocation concealment. Following consent and assessment, participants are randomised 1:1. Lung cancer with stage I-IIIA and treatment type is surgery +/- adjuvant treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantong University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Melbourne, The First Affiliated Hospital with Nanjing Medical University
- Responsible party
- Principal investigator, Jun Ni, Nantong University
- Investigators
- Jun Ni, MD, Principal investigator, Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185467
- Sponsor's protocol ID
- NantongU
- Status last verified
- Apr 2020
- First submitted
- 23 Nov 2019
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available to other investigators for individual participant data meta-analysis.
Publications
Hung R, Krebs P, Coups EJ, Feinstein MB, Park BJ, Burkhalter J, Ostroff JS. Fatigue and functional impairment in early-stage non-small cell lung cancer survivors. J Pain Symptom Manage. 2011 Feb;41(2):426-35. doi: 10.1016/j.jpainsymman.2010.05.017. Epub 2011 Jan 8.
PubMed 21216563Hong QY, Wu GM, Qian GS, Hu CP, Zhou JY, Chen LA, Li WM, Li SY, Wang K, Wang Q, Zhang XJ, Li J, Gong X, Bai CX; Lung Cancer Group of Chinese Thoracic Society; Chinese Alliance Against Lung Cancer. Prevention and management of lung cancer in China. Cancer. 2015 Sep 1;121 Suppl 17:3080-8. doi: 10.1002/cncr.29584.
PubMed 26331814Polanski J, Jankowska-Polanska B, Rosinczuk J, Chabowski M, Szymanska-Chabowska A. Quality of life of patients with lung cancer. Onco Targets Ther. 2016 Feb 29;9:1023-8. doi: 10.2147/OTT.S100685. eCollection 2016.
PubMed 27013895Zhang LL, Wang SZ, Chen HL, Yuan AZ. Tai Chi Exercise for Cancer-Related Fatigue in Patients With Lung Cancer Undergoing Chemotherapy: A Randomized Controlled Trial. J Pain Symptom Manage. 2016 Mar;51(3):504-11. doi: 10.1016/j.jpainsymman.2015.11.020. Epub 2015 Dec 22.
PubMed 26721747John LD. Self-care strategies used by patients with lung cancer to promote quality of life. Oncol Nurs Forum. 2010 May;37(3):339-47. doi: 10.1188/10.ONF.339-347.
PubMed 20439218Schmitz KH, Holtzman J, Courneya KS, Masse LC, Duval S, Kane R. Controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2005 Jul;14(7):1588-95. doi: 10.1158/1055-9965.EPI-04-0703.
PubMed 16030088Lin YY, Rau KM, Lin CC. Longitudinal study on the impact of physical activity on the symptoms of lung cancer survivors. Support Care Cancer. 2015 Dec;23(12):3545-53. doi: 10.1007/s00520-015-2724-7. Epub 2015 Apr 9.
PubMed 25855040Wang JW, Gong XH, Ding N, Chen XF, Sun L, Tang Z, Yu DH, Yuan ZP, Wang XD, Yu JM. The influence of comorbid chronic diseases and physical activity on quality of life in lung cancer survivors. Support Care Cancer. 2015 May;23(5):1383-9. doi: 10.1007/s00520-014-2494-7. Epub 2014 Oct 31.
PubMed 25358644Jones LW, Watson D, Herndon JE 2nd, Eves ND, Haithcock BE, Loewen G, Kohman L. Peak oxygen consumption and long-term all-cause mortality in nonsmall cell lung cancer. Cancer. 2010 Oct 15;116(20):4825-32. doi: 10.1002/cncr.25396.
PubMed 20597134Brown JC, Schmitz KH. The prescription or proscription of exercise in colorectal cancer care. Med Sci Sports Exerc. 2014 Dec;46(12):2202-9. doi: 10.1249/MSS.0000000000000355.
PubMed 24781887Gopalakrishnan V, Helmink BA, Spencer CN, Reuben A, Wargo JA. The Influence of the Gut Microbiome on Cancer, Immunity, and Cancer Immunotherapy. Cancer Cell. 2018 Apr 9;33(4):570-580. doi: 10.1016/j.ccell.2018.03.015.
PubMed 29634945Keohane DM, Woods T, O'Connor P, Underwood S, Cronin O, Whiston R, O'Sullivan O, Cotter P, Shanahan F, Molloy MGM. Four men in a boat: Ultra-endurance exercise alters the gut microbiome. J Sci Med Sport. 2019 Sep;22(9):1059-1064. doi: 10.1016/j.jsams.2019.04.004. Epub 2019 Apr 18.
PubMed 31053425Hamasaki H. Exercise and gut microbiota: clinical implications for the feasibility of Tai Chi. J Integr Med. 2017 Jul;15(4):270-281. doi: 10.1016/S2095-4964(17)60342-X.
PubMed 28659231
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Rehabilitation for Patients With Lung Cancer in China: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04185467
- Acronym / sponsor ID
- NantongU
- Conditions
- Lung Neoplasms
- Keywords
- lung cancer, exercise, rehabilitation, Tai Chi, health-related quality of life
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The coronavirus broke out in China at the end of 2019
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nantong UniversityUniversity, hospital or other
- Collaborators
- University of Melbourne, The First Affiliated Hospital with Nanjing Medical University
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is the leading cause of cancer death worldwide and associated with high disease burden, symptoms and poor health-related quality of life (HRQoL). Lung cancer is the most commonly diagnosed type of cancer in China (with rates rising due to the smoking incidence) and is the leading cause of cancer-related death. The burden is on patients, families, the healthcare system and society, and will continue to rise into the future. The full impact of this in China has not yet occurred. New strategies are urgently required to improve survivorship. This multi-site, assessor blinded, two-arm superiority randomised controlled trial, conducted at two hospitals in China, aims to test the effect of exercise rehabilitation, compared to usual care (no exercise rehabilitation) on HRQoL and functional outcomes in 150 patients treated for lung cancer. The primary hypothesis is that exercise rehabilitation will be superior to usual care, in improving HRQoL at 12-weeks (post program). Secondary aims include measuring the effectiveness of exercise rehabilitation, compared to usual care on function, physical activity, symptoms, mood, sleep and program costs. Faecal samples (500mg) will be collected before and after the intervention.
Detailed description
Lung cancer is the leading cause of cancer death worldwide and associated with high disease burden, symptoms and poor health-related quality of life (HRQoL). Lung cancer is the most commonly diagnosed type of cancer in China (with rates rising due to the smoking incidence) and is the leading cause of cancer-related death. The burden is on patients, families, the healthcare system and society, and will continue to rise into the future. The full impact of this in China has not yet occurred. New strategies are urgently required to improve survivorship. This multi-site, assessor blinded, two-arm superiority randomized controlled trial, conducted at two hospitals in China, aims to test the effect of exercise rehabilitation, compared to usual care (no exercise rehabilitation) on HRQoL and outcomes including physical function in 150 patients treated for lung cancer. The primary hypothesis is that exercise rehabilitation will be superior to usual care, in improving HRQoL at 12-weeks (post program). Secondary aims include include measuring the effectiveness of exercise rehabilitation, compared to usual care on function, physical activity, symptoms, mood, sleep and program costs.
One hundred and fifty patients with stage I-IIIA non-small cell lung cancer (NSCLC) 4-12 weeks following completion of treatment (including surgery with or without adjuvant therapy) and life expectancy greater than 6 months will be recruited from the affiliated hospital of Nantong University and the first affiliated hospital of Nanjing Medical University. At recruitment participants provide written informed consent, complete baseline assessment and to ensure concealment of allocation participants will be randomly allocated off-site to one of two arms (1:1 ratio). The intervention programs start following randomization and will continue for 12 weeks duration. Trained physiotherapists will provide the intervention. Patients in both arms will receive usual medical, physiotherapy and nursing care according to usual protocols. This does not involve exercise rehabilitation or advice. Additionally patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking) and resistance training and 30 minutes of 8 style Tai Chi). Participants will be advised to walk on days of non-attendance - this will be individualized with the aim to have participants increase to 30 minutes walking per day. Assessments will be conducted at baseline and then by blinded assessors at 12 weeks and 6 months post-baseline. Survival will be followed-up and censored at 1 year. This important study brings together a strong collaborative research team spanning China and Australia, involving medical doctors, physiotherapists and academics. The topic is important, novel and will generate clinically meaningful research for an international audience, aiming to improve the survivorship quality of patients with lung cancer.
The gut microbiome is a source of potentially disease-modifying bioactive metabolites and has recently been suggested to contribute to the pathogenesis of a variety of disorders. Therefore, we will study the gut microbiota and metabolites of the participants in order to identify potential the biomarkers for the clinical outcomes. Fresh faecal samples will be collected from all individuals before group assignment and after the completion of the program. The written informed consent will be provided by the participants.
Specifically, faecal samples (500mg) will be collected from participants who are free from gastrointestinal conditions, with no antibiotic exposure in the 28 days prior to sample collection. 'Snap' frozen samples will be stored at -80°C until the time of DNA extractions, 16S rDNA sequencing, and mass spectrometry analysis of the faecal metabolites. The distribution of gut microbiota before and after exercise will be compared and analyzed to obtain the species of bacterial flora that changed significantly after exercise. Moreover, the gut metabolites that changed significantly before and after exercise will be used to explore the biomarkers for the curative effect of rehabilitation exercise, as well as their relationships with the differentially distributed gut microbiota.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Design: Two-site, assessor blinded, two-arm superiority randomised controlled trial. Setting: Participant recruitment from the affiliated hospital of Nantong University and the first affiliated hospital of Nanjing Medical University Procedure: Randomisation: Randomisation list devised by independent statistician; carried out using the REDCap randomisation function to ensure allocation concealment. Following consent and assessment, participants are randomised 1:1. Lung cancer with stage I-IIIA and treatment type is surgery +/- adjuvant treatment.
| Arm | Type | Receives |
|---|---|---|
| Usual care(both arms) | No intervention | –Usual care (both arms): Patients in both arms will receive usual medical, physiotherapy and nursing care according to usual protocols. This does not involve exercise rehabilitation or advice. |
| Intervention (exercise rehabilitation) | Experimental | Other: Intervention (rehabilitation exercise)Patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking), resistance training and 30 minutes of 8 style Tai Chi. Participants will be advised to walk on days of non-attendance - this will be individualised with the aim to have participants increase to 30 minutes walking per day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with non-small cell lung cancer (NSCLC) 4-12 weeks following completion of treatment (surgery, chemotherapy, radiotherapy, immunotherapy);
- Physician/doctor approval;
- Physician rated life expectancy greater than 6 months;
- Informed consent;
- Eastern Cooperate Oncology Group (ECOG) performance status of 0-2 at study entry;
Key exclusion criteria (3 listed)
- Unstable psychiatric/cognitive disorder;
- Comorbidity preventing exercise;
- ECOG performance status of 3 or 4 at study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention (rehabilitation exercise)Patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking), resistance training and 30 minutes of 8 style Tai Chi. Participants will be advised to walk on days of non-attendance - this will be individualised with the aim to have participants increase to 30 minutes walking per day. | Other | Intervention (exercise rehabilitation) |
Primary outcome
European Organization for the Research and Treatment of Cancer questionnaire (EORTC QLQ-C30-LC13)
Time frame: The primary time point is the change from baseline to 12 weeks. This outcome will also be measured at 6 months post-baseline.
HRQoL will be assessed with the European Organization for the Research and Treatment of Cancer questionnaire (EORTC QLQ-C30-LC13) at baseline, 12 weeks and 6 months post-baseline. Score ranges from 0~100.For functional domains and global health status/quality of life scale, higher score means better status. While for symptom domains and single-items, lower scores represent less symptoms.
11 secondary outcomes
Functional Exercise Capacity
Time frame: 1) baseline, 2) 12 week, and 3) 6 months post-baseline.
Seven-day Physical Activity
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Grip strength
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
30-Second Chair Stand
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
International physical activity questionnaire(IPAQ)
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Self-Rating Anxiety Scale(SAS)
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Self-Rating Depression Scale(SDS)
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Pittsburgh Sleep Quality Index(PSQI)
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
MD Anderson Symptom Inventory-lung cancer (MDASI-LC)
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Australia-modified Karnofsky Performance Status(AKPS)
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
European quality of life 5-dimension 5-level(EQ-5D-5L)
Time frame: 1) baseline, 2) 12 weeks, and 3) 6 months post-baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Background: PubMed 21216563Hung R, Krebs P, Coups EJ, Feinstein MB, Park BJ, Burkhalter J, Ostroff JS. Fatigue and functional impairment in early-stage non-small cell lung cancer survivors. J Pain Symptom Manage. 2011 Feb;41(2):426-35. doi: 10.1016/j.jpainsymman.2010.05.017. Epub 2011 Jan 8.
- Background: PubMed 26331814Hong QY, Wu GM, Qian GS, Hu CP, Zhou JY, Chen LA, Li WM, Li SY, Wang K, Wang Q, Zhang XJ, Li J, Gong X, Bai CX; Lung Cancer Group of Chinese Thoracic Society; Chinese Alliance Against Lung Cancer. Prevention and management of lung cancer in China. Cancer. 2015 Sep 1;121 Suppl 17:3080-8. doi: 10.1002/cncr.29584.
- Background: PubMed 27013895Polanski J, Jankowska-Polanska B, Rosinczuk J, Chabowski M, Szymanska-Chabowska A. Quality of life of patients with lung cancer. Onco Targets Ther. 2016 Feb 29;9:1023-8. doi: 10.2147/OTT.S100685. eCollection 2016.
- Background: PubMed 26721747Zhang LL, Wang SZ, Chen HL, Yuan AZ. Tai Chi Exercise for Cancer-Related Fatigue in Patients With Lung Cancer Undergoing Chemotherapy: A Randomized Controlled Trial. J Pain Symptom Manage. 2016 Mar;51(3):504-11. doi: 10.1016/j.jpainsymman.2015.11.020. Epub 2015 Dec 22.
- Background: PubMed 20439218John LD. Self-care strategies used by patients with lung cancer to promote quality of life. Oncol Nurs Forum. 2010 May;37(3):339-47. doi: 10.1188/10.ONF.339-347.
- Background: PubMed 16030088Schmitz KH, Holtzman J, Courneya KS, Masse LC, Duval S, Kane R. Controlled physical activity trials in cancer survivors: a systematic review and meta-analysis. Cancer Epidemiol Biomarkers Prev. 2005 Jul;14(7):1588-95. doi: 10.1158/1055-9965.EPI-04-0703.
- Background: PubMed 25855040Lin YY, Rau KM, Lin CC. Longitudinal study on the impact of physical activity on the symptoms of lung cancer survivors. Support Care Cancer. 2015 Dec;23(12):3545-53. doi: 10.1007/s00520-015-2724-7. Epub 2015 Apr 9.
- Background: PubMed 25358644Wang JW, Gong XH, Ding N, Chen XF, Sun L, Tang Z, Yu DH, Yuan ZP, Wang XD, Yu JM. The influence of comorbid chronic diseases and physical activity on quality of life in lung cancer survivors. Support Care Cancer. 2015 May;23(5):1383-9. doi: 10.1007/s00520-014-2494-7. Epub 2014 Oct 31.
- Background: PubMed 20597134Jones LW, Watson D, Herndon JE 2nd, Eves ND, Haithcock BE, Loewen G, Kohman L. Peak oxygen consumption and long-term all-cause mortality in nonsmall cell lung cancer. Cancer. 2010 Oct 15;116(20):4825-32. doi: 10.1002/cncr.25396.
- Background: PubMed 24781887Brown JC, Schmitz KH. The prescription or proscription of exercise in colorectal cancer care. Med Sci Sports Exerc. 2014 Dec;46(12):2202-9. doi: 10.1249/MSS.0000000000000355.
- Background: PubMed 29634945Gopalakrishnan V, Helmink BA, Spencer CN, Reuben A, Wargo JA. The Influence of the Gut Microbiome on Cancer, Immunity, and Cancer Immunotherapy. Cancer Cell. 2018 Apr 9;33(4):570-580. doi: 10.1016/j.ccell.2018.03.015.
- Background: PubMed 31053425Keohane DM, Woods T, O'Connor P, Underwood S, Cronin O, Whiston R, O'Sullivan O, Cotter P, Shanahan F, Molloy MGM. Four men in a boat: Ultra-endurance exercise alters the gut microbiome. J Sci Med Sport. 2019 Sep;22(9):1059-1064. doi: 10.1016/j.jsams.2019.04.004. Epub 2019 Apr 18.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available to other investigators for individual participant data meta-analysis.
Related trials for Lung Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Ni, MD principal investigator
Nantong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention (rehabilitation exercise) in people with Lung Neoplasms, run by Nantong University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 3 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
European Organization for the Research and Treatment of Cancer questionnaire (EORTC QLQ-C30-LC13) (time frame: The primary time point is the change from baseline to 12 weeks. This outcome will also be measured at 6 months post-baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185467, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2020.