Lung CancerNCT02938104
Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery
A study testing Whey Protein Isolate Powder, Physical Exercise Program and Relaxation Techniques in people with Lung Cancer, run by Franco Carli at 1 site in Canada.
Trial summary
The investigators propose a randomized controlled study in patients undergoing lung resection for cancer to compare the impact of multimodal intervention composed of exercise, nutritional supplement and psychological well-being on functional exercise capacity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Whey Protein Isolate Powder, Physical Exercise Program and Relaxation Techniques
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Sep 2017
- 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
- aged 18 and above
- referred electively for resection of malignant, non-metastasized lung lesion
Who cannot join
- persons with American Society of Anesthesiologists (ASA) health status class 4-5
- persons with co-morbid medical, physical, and mental abnormalities (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardia failure, COPD, renal failure, sepsis, morbid obesity, anemia, and other conditions interfering with the ability to perform exercise at home or to complete testing procedures
- poor English or French comprehension
Trial locations and contacts
1 site in 1 country.
About this study
The investigators propose a randomized controlled study in patients undergoing lung resection for cancer to compare the impact of multimodal intervention composed of exercise, nutritional supplement and psychological well-being on functional exercise capacity. One group (rehabilitation group) will receive the multimodal intervention after surgery for 8 weeks; the other will start 4 weeks before surgery and continue for 8 weeks postop (prehabilitation group). In this case, both groups will be exposed to the program, which will be available to both groups postoperatively. One of the two groups will start this program 4 weeks before surgery and continue for 8 weeks postoperatively, and the other will start once they leave the hospital and continue for 8 weeks postoperatively.
Read the detailed description
Interventions
The multidisciplinary program is composed of 3 elements: exercise, nutritional supplements and psychological coping strategies
Exercise program
Patients will be seen by a kinesiologist for a period of 1 hour and he/she will assess patients' mobility and capacity to undertake exercise, will prepare a personalized program and will explain and monitor the exercise program. Patients will be instructed on how to conduct aerobic exercise in the lab and at home, by either walking or cycling initially at 50% of the calculated heart rate reserve for 20 min three times per week, and this will be increased in stepwise increments by 10% each week, if tolerable.
Muscular resistance training will be also carried out 3 times a week to avoid muscle soreness. Persons will be instructed to do push-up, sit-ups, and standing strides (lunges) until volitional fatigue increasing this number to reach 12 repetitions. The resistance chosen for strengthening of biceps, deltoids and quadriceps will be based on what the person can lift to reach volitional fatigue with 8 repetitions.
Psychological program
It is expected that patients undergoing surgery for cancer are anxious with some component of depression. Since both anxiety and depression can influence the motivation to carry out social and functional activities, psychological strategies can be put in place to help patients to cope with the stress of surgery and disease. For this reason patients will be seen by a trained psychologist. Patients will receive a total of 1.5 hours of psychological intervention in the first session and more sessions if necessary.
In the first preoperative session, the first hour will address the patient's anxieties, coping strategies, and post-operative expectations, with the goal of optimizing psychological well-being \& ways of coping with surgery. The importance of the patient's active participation in the healing process will also be discussed. The last thirty minutes will be devoted to teaching relaxation techniques and breathing exercises. Patients will be given a relaxation CD to take home for practice.
Nutritional supplementation
The nutritional status of patients affected by lung cancer is directly influenced by the presence of cancer, which impacts on all aspects of intermediary (protein, carbohydrate, lipid, trace element, vitamin) metabolism, and by other factors such as age, adjuvant cancer therapy and stage of the disease. The greater sensitivity of protein catabolism to nutritional support, in particular to amino acids, could have important implications for the nutritional management of these patients during the period of catabolic stress, with particular emphasis on substrate utilization and energy requirement.
The patients' nutritional status and dietary intake will be assessed by the nutritionist. Percentage of lean body mass and fat percentage will be measured. All patients will receive a daily dietary supplement known as whey protein (Immunocal, Immunotec ©). Special precautions will be considered if patients have specific medical conditions (e.g. diabetes).
- Conditions
- Lung Cancer
- Being tested
- Whey Protein Isolate Powder, Physical Exercise Program, Relaxation Techniques
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein Isolate PowderDietary supplement
Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Posder (Immunocal) is provided.
Immunocal (1.5g/kg PO (by mouth) per day in daily doses
Physical Exercise ProgramBehavioural
Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
Relaxation TechniquesBehavioural
Relaxation techniques consisting of breathing exercises and using a relaxation CD
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Immediately after randomization, until surgery and to be continued for 8 weeks after surgery, patients in this arm will:
1. Receive a personalized physical exercise program
2. Receive nutritional counselling with whey protein isolate powder
3. Receive relaxation techniques Receives: Dietary Supplement: Whey Protein Isolate Powder; Behavioral: Physical Exercise Program; Behavioral: Relaxation Techniques |
| Rehabilitation | Active comparator | Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patient in the other arm but to be started after surgery. Receives: Dietary Supplement: Whey Protein Isolate Powder; Behavioral: Physical Exercise Program; Behavioral: Relaxation Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test
The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.
Measured: 8 weeks after surgery
Secondary outcomes (5)
Health-related quality of life
The SF-36 incorporates behavioural functioning, subjective well-being and perceptions of health by assessing, on a 0 to 100 scale, eight health concepts: (1) Physical function (PF) -limitations in physical activities due to health problems; (2) Role physical (RP)-limitations in role activities due to physical health problems; (3) Role emotional (RE) -limitations in usual role activities due to emotional problems; (4) Social functioning (SF) -limitations in social activities due to health problems; (5) Bodily pain (BP)-pain; (6) General health (GH) -general health perceptions; (7) Vitality (VT) -energy and fatigue; and (8) Mental health (MH) -general mental health.
Measured: 8 weeks after surgery
Quality of Life
The FACT-L (functional assessment of cancer therapy lung) and EQ-5D, both validated measures, will be used to assess quality of life.
Measured: 8 weeks after surgery
Physical activity level
Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire.
Measured: 8 weeks after surgery
Depression and anxiety
The Hospital Anxiety and Depression Scale (HADS) will be used to assess anxiety and depression.
Measured: 8 weeks after surgery
Nutritional status
Nutritional status will be assessed using body, body weight loss over the preceding three months (>10%), and/or serum albumin < 35 g -1 will define poor nutritional status. Hand grip strength and body impedance will also be measured.
Measured: 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startAug 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franco Carli
- Sponsor type
- University, hospital or other
- Collaborators
- Immunotec Inc.
- Responsible party
- Sponsor-investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Franco Carli, MD, Principal investigator, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938104
- Sponsor's protocol ID
- 14-193-GEN
- Status last verified
- Mar 2018
- First submitted
- 2 Feb 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Prehabilitation to Enhance Functional Recovery After Lung Surgery
- ClinicalTrials.gov ID
- NCT02938104
- Acronym / sponsor ID
- 14-193-GEN
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Franco CarliUniversity, hospital or other
- Collaborators
- Immunotec Inc.
- Study start
- Aug 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 19 Oct 2016 (estimated)
- 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.
The investigators propose a randomized controlled study in patients undergoing lung resection for cancer to compare the impact of multimodal intervention composed of exercise, nutritional supplement and psychological well-being on functional exercise capacity. One group (rehabilitation group) will receive the multimodal intervention after surgery for 8 weeks; the other will start 4 weeks before surgery and continue for 8 weeks postop (prehabilitation group). In this case, both groups will be exposed to the program, which will be available to both groups postoperatively. One of the two groups will start this program 4 weeks before surgery and continue for 8 weeks postoperatively, and the other will start once they leave the hospital and continue for 8 weeks postoperatively.
Detailed description
Interventions
The multidisciplinary program is composed of 3 elements: exercise, nutritional supplements and psychological coping strategies
Exercise program
Patients will be seen by a kinesiologist for a period of 1 hour and he/she will assess patients' mobility and capacity to undertake exercise, will prepare a personalized program and will explain and monitor the exercise program. Patients will be instructed on how to conduct aerobic exercise in the lab and at home, by either walking or cycling initially at 50% of the calculated heart rate reserve for 20 min three times per week, and this will be increased in stepwise increments by 10% each week, if tolerable.
Muscular resistance training will be also carried out 3 times a week to avoid muscle soreness. Persons will be instructed to do push-up, sit-ups, and standing strides (lunges) until volitional fatigue increasing this number to reach 12 repetitions. The resistance chosen for strengthening of biceps, deltoids and quadriceps will be based on what the person can lift to reach volitional fatigue with 8 repetitions.
Psychological program
It is expected that patients undergoing surgery for cancer are anxious with some component of depression. Since both anxiety and depression can influence the motivation to carry out social and functional activities, psychological strategies can be put in place to help patients to cope with the stress of surgery and disease. For this reason patients will be seen by a trained psychologist. Patients will receive a total of 1.5 hours of psychological intervention in the first session and more sessions if necessary.
In the first preoperative session, the first hour will address the patient's anxieties, coping strategies, and post-operative expectations, with the goal of optimizing psychological well-being \& ways of coping with surgery. The importance of the patient's active participation in the healing process will also be discussed. The last thirty minutes will be devoted to teaching relaxation techniques and breathing exercises. Patients will be given a relaxation CD to take home for practice.
Nutritional supplementation
The nutritional status of patients affected by lung cancer is directly influenced by the presence of cancer, which impacts on all aspects of intermediary (protein, carbohydrate, lipid, trace element, vitamin) metabolism, and by other factors such as age, adjuvant cancer therapy and stage of the disease. The greater sensitivity of protein catabolism to nutritional support, in particular to amino acids, could have important implications for the nutritional management of these patients during the period of catabolic stress, with particular emphasis on substrate utilization and energy requirement.
The patients' nutritional status and dietary intake will be assessed by the nutritionist. Percentage of lean body mass and fat percentage will be measured. All patients will receive a daily dietary supplement known as whey protein (Immunocal, Immunotec ©). Special precautions will be considered if patients have specific medical conditions (e.g. diabetes).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Dietary Supplement: Whey Protein Isolate Powder, Behavioral: Physical Exercise Program, Behavioral: Relaxation TechniquesImmediately after randomization, until surgery and to be continued for 8 weeks after surgery, patients in this arm will: 1. Receive a personalized physical exercise program 2. Receive nutritional counselling with whey protein isolate powder 3. Receive relaxation techniques |
| Rehabilitation | Active comparator | Dietary Supplement: Whey Protein Isolate Powder, Behavioral: Physical Exercise Program, Behavioral: Relaxation TechniquesPatients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patient in the other arm but to be started after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18 and above
- referred electively for resection of malignant, non-metastasized lung lesion
Key exclusion criteria (3 listed)
- persons with American Society of Anesthesiologists (ASA) health status class 4-5
- persons with co-morbid medical, physical, and mental abnormalities (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardia failure, COPD, renal failure, sepsis, morbid obesity, anemia, and other conditions interfering with the ability to perform exercise at home or to complete testing procedures
- poor English or French comprehension
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 |
|---|---|---|
| Whey Protein Isolate PowderNutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Posder (Immunocal) is provided. Immunocal (1.5g/kg PO (by mouth) per day in daily doses | Dietary supplement | Prehabilitation, Rehabilitation |
| Physical Exercise ProgramPhysical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises. | Behavioural | Prehabilitation, Rehabilitation |
| Relaxation TechniquesRelaxation techniques consisting of breathing exercises and using a relaxation CD | Behavioural | Prehabilitation, Rehabilitation |
Primary outcome
Six-minute walk test
Time frame: 8 weeks after surgery
The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk; encouragement and feedback are given according to published guidelines.
5 secondary outcomes
Health-related quality of life
Time frame: 8 weeks after surgery
Quality of Life
Time frame: 8 weeks after surgery
Physical activity level
Time frame: 8 weeks after surgery
Depression and anxiety
Time frame: 8 weeks after surgery
Nutritional status
Time frame: 8 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Lung Cancer
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.
Franco Carli, MD principal investigator
Montreal General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein Isolate Powder, Physical Exercise Program and Relaxation Techniques in people with Lung Cancer, run by Franco Carli 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 2 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: finished, as of the sponsor's last update on 22 Mar 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Six-minute walk test (time frame: 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2018.