Lung CancerNCT04610606
Pilot Prehabilitation Intervention in Lung Cancer
A study testing Multimodal intervention (MM) in people with Lung Cancer and Surgery, run by McGill University at 1 site in Canada.
Trial summary
Lung cancer is the second most prevalent cancer in Canada and the leading cause of cancer-related mortality worldwide. Patients diagnosed at earlier (non-metastatic) stages are potential candidates for surgical tumor removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Surgery
- What is being tested?
- Multimodal intervention (MM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 11 Oct 2019to 12 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult men and women with NSCLC stages I, II or IIIa, planned for video-assisted thoracic surgery (VATS) or open thoracotomy surgery for cancer resection or exploration.
Who cannot join
- prior recent (<3 mo) chemotherapy, comorbidities contraindicating exercise (defined as CPET <10 mL O2/kg/min), walking aids other than a cane, glomerular filtration rate <30 mL/min/m2, allergy to milk or seafoods, chronic use of anti-coagulants, hypercalcemia, hypervitaminosis D, insufficient understanding of English or French language to provide informed consent. All medications and co-morbidities will be recorded. Patients taking vitamin D will continue their supplements; risk of potential overdosing will be monitored by serum 25(OH)D levels >80 nmol/L. Those taking n-3 FA supplements will be asked to withhold during the study.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
About this study
Official title: A Novel Multimodal Intervention for Surgical Prehabilitation of Patients With Lung Cancer: Pilot Study
Lung cancer is the second most prevalent cancer in Canada and the leading cause of cancer-related mortality worldwide. Patients diagnosed at earlier (non-metastatic) stages are potential candidates for surgical tumor removal. However, they often present with poor nutritional status and physical function adding to the major catabolic stress imposed by surgery that negatively impacts recovery and survival after surgery. The purpose of this study is to investigate the potential benefits of a prehabilitation program that includes a combined nutritional supplement (whey protein, leucine, vitamin D and omega-3 fatty acids) with exercise and relaxation techniques for 4 weeks before surgery and continued for 8 weeks after surgery on functional pre- and postoperative outcomes, versus standard hospital care (control). Investigators will study whether the prehabilitation program improves physical performance, muscle mass and quality of life in patients undergoing lung cancer resection. The specific objective of this pilot study is to test feasibility and adherence to intervention, and generate pilot data to inform the design of a larger trial.
Read the detailed description
RATIONALE: The preoperative period is an opportune time to actively engage and empower patients in improving their functional, nutritional and mental status in anticipation of the surgical stress. Considering that lung cancer patients often present with poor nutritional status and physical function prior to surgery providing a nutritional supplement to increase protein, leucine, vitamin D and omega-3 FA intake with a structured exercise program and relaxation techniques should improve muscle mass, strength and physical performance.
MAIN OBJECTIVE: to test the effect of a multimodal prehabilitation intervention (MM) combining a mixed-nutrient supplement with structured exercise training against standard of care (SOC), on functional pre- and postoperative outcomes in surgical patients with lung cancer, in an open-label RCT.
The present is a pilot study aiming to generate feasibility data (recruitment rate, compliance, attrition) and preliminary outcome data to support a larger trial.
STUDY DESIGN: Open-label, randomized, controlled trial of two parallel arms: multimodal intervention (MM) and standard of care (SOC). After baseline assessment, patients will be randomized to either group in a 1:2 SOC:MM ratio using a computer-generated randomization scheme by block of four, with stratification by sex and functional capacity (< or > 400 m on the 6MWT). Consecutive adult patients scheduled for elective video-assisted thoracic surgery or open thoracotomy surgery of NSCLC stages I, II or IIIa, will be approached following their first appointment with their surgeon at the MUHC-Montreal General Hospital.
INTERVENTION: The EXP arm will ingest a multi-nutrient supplement consisting of whey protein + leucine and fish oil + vitamin D, perform structured exercise and relaxation techniques for 4 weeks prior to surgery and 8 weeks after surgery. Control group will received standard hospital care and education on benefits of physical activity and healthy diet. Outcome assessment will be performed at baseline, preoperative, 4 and 8 weeks postoperatively.
OUTCOMES: Primary: feasibility; Secondary: physical function, muscle strength, volume and density, body composition, quality of life, length of stay and post-operative complications; Other: dietary intake, physical activity, clinical markers.
STATISTICAL ANALYSIS: This is a pilot study designed to generate data on feasibility and compliance to the intervention and study tests; it is not powered for identifying statistical differences in the main outcomes. The investigators will recruit 36 participants on a 1:2 ratio (12 SOC: 24 MM).
- Conditions
- Lung Cancer, Surgery
- Being tested
- Multimodal intervention (MM)
- Keywords
- Prehabilitation, Nutritional supplement
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal intervention (MM)Behavioural
Exercise: Moderate intensity resistance and aerobic exercise, including one weekly supervised session and a home-based program. Participants were asked to 1) accumulate 30 min of aerobic exercise per day of their preferred type (ex. walking) and 2) perform 30 min of resistance exercise targeting major muscle groups, every second day for 2 sets of 8-12 reps.
Nutrition: Optimize diet with protein-rich foods to meet protein intake of >1.2 g/kg/d and energy of 25-30 kcal/kg/d. The supplement consists of whey protein isolate (with the goal of reaching 1.5 g/kg/d, providing 25 g/meal), 6g of leucine, fruit-flavored fish oil added with vitamin D.
Relaxation strategies: private consultations with psychology-trained personnel whereby techniques aimed at reducing anxiety are practiced. Participants are also provided with a compact disc with relaxation exercises to be used at home 2-3 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal intervention (MM) | Experimental | Multimodal prehabilitation including structured exercise (1 supervised exercise session per week + home-based exercise program), nutritional optimization (diet + mixed nutrient supplement containing whey protein, leucine, vitamin D and omega 3 fatty acids) and relaxation strategies. Receives: Behavioral: Multimodal intervention (MM) |
| Standard of care (SOC) | No intervention | Education on benefits of physical activity and healthy diet, with no specific information. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Recruitment rate
Recruitment rate (measured in percent, compared to expected rates)
Measured: Over entire recruitment period (approximately 1 year)
Feasibility: Adherence to intervention
Adherence to exercise and nutritional interventions (measured in percent, compared to expected rates)
Measured: Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)
Feasibility: completion of study outcome assessment
Completion of study outcome assessments (measured in percent, compared to expected rates)
Measured: Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)
Secondary outcomes (10)
Functional walking capacity
Six-minute walking test: measured as the distance walked during 6 minutes, along a 20-m corridor, expressed in m)
Measured: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Length of hospital stay
Recorded from medical charts
Measured: 8-week postoperative
Post-operative complications
Recorded from medical charts and will be graded by severity following the Clavien-Dindo classification.
Measured: 8-week postoperative
Health related quality of life
Measured by the cumulative score of the 36-item Short Form Health Survey, score 0-100, higher score means better quality of life.
Measured: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Quality of Life
Measured by cumulative score of the Functional Assessment of Cancer Therapy - Lung questionnaires, score 0-136, higher means better quality of life.
Measured: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Muscle strength - handgrip
Handgrip strength using hand-held Jamar dynamometer, measured in kg.
Measured: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Muscle strength - leg
Isokinetic leg strength (knee extension peak torque) using Biodex, measured in N, on the dominant side.
Measured: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Muscle volume
Skeletal muscle volume will be measured in the dominant foreleg, using peripheral quantitative CT (pQCT, Stratec XCT2000).
Measured: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Muscle radiodensity
Skeletal muscle density will be measured in the dominant foreleg, using peripheral quantitative CT (pQCT, Stratec XCT2000).
Measured: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Body composition
Lean and fat mass will be measured by bioelectrical impedance (InBody 230V)
Measured: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start11 Oct 2019
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: Covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, randomized, controlled trial of two parallel arms: multimodal intervention (MM) and standard of care (SOC).
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Peri-Operative Program Charitable Foundation, MUHC-Montreal General Hospital Foundation
- Responsible party
- Principal investigator, Stéphanie Chevalier, McGill University
- Investigators
- Stéphanie Chevalier, PhD, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610606
- Sponsor's protocol ID
- MUHC REB 2020-5633
- Status last verified
- Oct 2020
- First submitted
- 24 Sep 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing was not planned originally and therefore consent was not obtained for it.
Publications
Lawson C, Ferreira V, Carli F, Chevalier S. Effects of multimodal prehabilitation on muscle size, myosteatosis, and dietary intake of surgical patients with lung cancer - a randomized feasibility study. Appl Physiol Nutr Metab. 2021 Nov;46(11):1407-1416. doi: 10.1139/apnm-2021-0249. Epub 2021 Jul 15.
PubMed 34265218
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Multimodal Intervention for Surgical Prehabilitation of Patients With Lung Cancer: Pilot Study
- ClinicalTrials.gov ID
- NCT04610606
- Acronym / sponsor ID
- MUHC REB 2020-5633
- Conditions
- Lung Cancer, Surgery
- Keywords
- Prehabilitation, Nutritional supplement
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 pandemic
- Enrolment
- 34 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Peri-Operative Program Charitable Foundation, MUHC-Montreal General Hospital Foundation
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 30 Oct 2020 (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 second most prevalent cancer in Canada and the leading cause of cancer-related mortality worldwide. Patients diagnosed at earlier (non-metastatic) stages are potential candidates for surgical tumor removal. However, they often present with poor nutritional status and physical function adding to the major catabolic stress imposed by surgery that negatively impacts recovery and survival after surgery. The purpose of this study is to investigate the potential benefits of a prehabilitation program that includes a combined nutritional supplement (whey protein, leucine, vitamin D and omega-3 fatty acids) with exercise and relaxation techniques for 4 weeks before surgery and continued for 8 weeks after surgery on functional pre- and postoperative outcomes, versus standard hospital care (control). Investigators will study whether the prehabilitation program improves physical performance, muscle mass and quality of life in patients undergoing lung cancer resection. The specific objective of this pilot study is to test feasibility and adherence to intervention, and generate pilot data to inform the design of a larger trial.
Detailed description
RATIONALE: The preoperative period is an opportune time to actively engage and empower patients in improving their functional, nutritional and mental status in anticipation of the surgical stress. Considering that lung cancer patients often present with poor nutritional status and physical function prior to surgery providing a nutritional supplement to increase protein, leucine, vitamin D and omega-3 FA intake with a structured exercise program and relaxation techniques should improve muscle mass, strength and physical performance.
MAIN OBJECTIVE: to test the effect of a multimodal prehabilitation intervention (MM) combining a mixed-nutrient supplement with structured exercise training against standard of care (SOC), on functional pre- and postoperative outcomes in surgical patients with lung cancer, in an open-label RCT.
The present is a pilot study aiming to generate feasibility data (recruitment rate, compliance, attrition) and preliminary outcome data to support a larger trial.
STUDY DESIGN: Open-label, randomized, controlled trial of two parallel arms: multimodal intervention (MM) and standard of care (SOC). After baseline assessment, patients will be randomized to either group in a 1:2 SOC:MM ratio using a computer-generated randomization scheme by block of four, with stratification by sex and functional capacity (< or > 400 m on the 6MWT). Consecutive adult patients scheduled for elective video-assisted thoracic surgery or open thoracotomy surgery of NSCLC stages I, II or IIIa, will be approached following their first appointment with their surgeon at the MUHC-Montreal General Hospital.
INTERVENTION: The EXP arm will ingest a multi-nutrient supplement consisting of whey protein + leucine and fish oil + vitamin D, perform structured exercise and relaxation techniques for 4 weeks prior to surgery and 8 weeks after surgery. Control group will received standard hospital care and education on benefits of physical activity and healthy diet. Outcome assessment will be performed at baseline, preoperative, 4 and 8 weeks postoperatively.
OUTCOMES: Primary: feasibility; Secondary: physical function, muscle strength, volume and density, body composition, quality of life, length of stay and post-operative complications; Other: dietary intake, physical activity, clinical markers.
STATISTICAL ANALYSIS: This is a pilot study designed to generate data on feasibility and compliance to the intervention and study tests; it is not powered for identifying statistical differences in the main outcomes. The investigators will recruit 36 participants on a 1:2 ratio (12 SOC: 24 MM).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, randomized, controlled trial of two parallel arms: multimodal intervention (MM) and standard of care (SOC).
| Arm | Type | Receives |
|---|---|---|
| Multimodal intervention (MM) | Experimental | Behavioral: Multimodal intervention (MM)Multimodal prehabilitation including structured exercise (1 supervised exercise session per week + home-based exercise program), nutritional optimization (diet + mixed nutrient supplement containing whey protein, leucine, vitamin D and omega 3 fatty acids) and relaxation strategies. |
| Standard of care (SOC) | No intervention | –Education on benefits of physical activity and healthy diet, with no specific information. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult men and women with NSCLC stages I, II or IIIa, planned for video-assisted thoracic surgery (VATS) or open thoracotomy surgery for cancer resection or exploration.
Key exclusion criteria (1 listed)
- prior recent (<3 mo) chemotherapy, comorbidities contraindicating exercise (defined as CPET <10 mL O2/kg/min), walking aids other than a cane, glomerular filtration rate <30 mL/min/m2, allergy to milk or seafoods, chronic use of anti-coagulants, hypercalcemia, hypervitaminosis D, insufficient understanding of English or French language to provide informed consent. All medications and co-morbidities will be recorded. Patients taking vitamin D will continue their supplements; risk of potential overdosing will be monitored by serum 25(OH)D levels >80 nmol/L. Those taking n-3 FA supplements will be asked to withhold during the study.
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 |
|---|---|---|
| Multimodal intervention (MM)Exercise: Moderate intensity resistance and aerobic exercise, including one weekly supervised session and a home-based program. Participants were asked to 1) accumulate 30 min of aerobic exercise per day of their preferred type (ex. walking) and 2) perform 30 min of resistance exercise targeting major muscle groups, every second day for 2 sets of 8-12 reps. Nutrition: Optimize diet with protein-rich foods to meet protein intake of >1.2 g/kg/d and energy of 25-30 kcal/kg/d. The supplement consists of whey protein isolate (with the goal of reaching 1.5 g/kg/d, providing 25 g/meal), 6g of leucine, fruit-flavored fish oil added with vitamin D. Relaxation strategies: private consultations with psychology-trained personnel whereby techniques aimed at reducing anxiety are practiced. Participants are also provided with a compact disc with relaxation exercises to be used at home 2-3 times per week. | Behavioural | Multimodal intervention (MM) |
Primary outcome
Feasibility: Recruitment rate
Time frame: Over entire recruitment period (approximately 1 year)
Recruitment rate (measured in percent, compared to expected rates)
Feasibility: Adherence to intervention
Time frame: Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)
Adherence to exercise and nutritional interventions (measured in percent, compared to expected rates)
Feasibility: completion of study outcome assessment
Time frame: Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)
Completion of study outcome assessments (measured in percent, compared to expected rates)
10 secondary outcomes
Functional walking capacity
Time frame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Length of hospital stay
Time frame: 8-week postoperative
Post-operative complications
Time frame: 8-week postoperative
Health related quality of life
Time frame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Quality of Life
Time frame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Muscle strength - handgrip
Time frame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Muscle strength - leg
Time frame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Muscle volume
Time frame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Muscle radiodensity
Time frame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Body composition
Time frame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Results and safety
The study was stopped early (reason given: Covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2020.
- Derived from this study: PubMed 34265218Lawson C, Ferreira V, Carli F, Chevalier S. Effects of multimodal prehabilitation on muscle size, myosteatosis, and dietary intake of surgical patients with lung cancer - a randomized feasibility study. Appl Physiol Nutr Metab. 2021 Nov;46(11):1407-1416. doi: 10.1139/apnm-2021-0249. Epub 2021 Jul 15.
- Individual participant dataSharing planned: No. IPD sharing was not planned originally and therefore consent was not obtained for it.
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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.
Stéphanie Chevalier, PhD principal investigator
Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention (MM) in people with Lung Cancer and Surgery, run by McGill University at 1 site in Canada.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study was stopped early (reason given: Covid-19 pandemic). 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?
Feasibility: Recruitment rate (time frame: Over entire recruitment period (approximately 1 year)). The study lists 3 primary outcomes in all. 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 NCT04610606, which also lists 1 linked publication.
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 30 Oct 2020.