Ignite Creation Date:
2024-05-06 @ 7:16 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05955248
Status:
RECRUITING
Last Update Posted:
2023-07-21
First Post:
2023-06-22
Brief Title:
Multimodal Prehabilitation for Lung Cancer Surgery
Sponsor:
Stéphanie Chevalier
Organization:
McGill University
Study Overview
Official Title:
A Novel Multimodal Intervention for Surgical Prehabilitation of Patients With Lung Cancer the MMP-LUNG Trial
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MMP-LUNG
Brief Summary:
The main objective of this randomized controlled trial RCT is to investigate whether a multimodal prehabilitation intervention combining a mixed-nutrient supplement with structured exercise training MM or the supplement alone NUT against a placebo CTRL leads to improvement in functional capacity and postoperative outcomes in surgical patients with lung cancer at nutritional risk This will be tested in a single centre RCT of 3 parallel arms double-blinded for the supplement Female and male participants n168 45 y will be randomized to a 10-week intervention spanning 4 weeks pre-surgery and 6 weeks post-hospital discharge The primary outcome is functional capacity as measured by the 6-minute walk test Secondary outcomes include muscle mass quality and strength quality of life length of hospital stay and postoperative complications
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 fatty acid 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 RCT prehabilitation intervention MM combining a mixed-nutrient supplement with structured exercise training or the supplement alone NUT against a placebo CTRL on functional pre- and postoperative outcomes in surgical patients with lung cancer at nutritional risk
STUDY DESIGN 10-week randomized controlled trial of 3 parallel arms double-blinded for supplement control CTRL multi-nutrient supplement NUT and multimodal intervention MM After baseline assessment patients will be randomized to either group in a 111 CTRLNUTMM ratio using a computer-generated randomization scheme by permuted block sizes with stratification by sex and functional capacity or 450 m on the 6-minute walk test 6MWT Consecutive adult patients or 45 years scheduled for elective video-assisted thoracic surgery or open thoracotomy surgery of non-small cell lung cancer NSCLC stages I II or IIIa and a Patient-Generated Subjective Global Assessment PG-SGA score or 3 will be approached following their first appointment with their surgeon at the McGill University Health Centre MUHC-Montreal General Hospital
INTERVENTION The NUT arm will ingest a multi-nutrient supplement consisting of whey protein leucine viatmin D and fish oil The CTRL participants will receive placebo supplements with the same physical aspect flavor and packaging as the active supplementThe MM arm will receive the NUT intervention in addition to performing structured exercise and relaxation techniques for 4 weeks prior to surgery and 6 weeks after hospital discharge
OUTCOMES Primary physical capacity measured by the 6MWT Secondary physical function muscle strength total skeletal muscle mass leg muscle volume and density body composition quality of life length of stay and post-operative complications Other dietary intake physical activity exercise tolerance pulmonary function clinical markers
STATISTICAL ANALYSIS Intention-to-treat analysis will be performed in the primary analyses For preoperative data analysis of covariance ANCOVA will compare between-group differences at 4-week preoperative time conditioned for baseline data including predefined covariates in the model age sex BMI The hypothesis of full recovery from the intervention at 6 weeks postoperative ie 6MWT returning back to or exceeding baseline will be tested by logistic regression yesno Between-group changes in other outcomes will be evaluated as differences in mean or proportions as appropriate with 95 CIs
MAIN OBJECTIVE to test the effect of a multimodal RCT prehabilitation intervention MM combining a mixed-nutrient supplement with structured exercise training or the supplement alone NUT against a placebo CTRL on functional pre- and postoperative outcomes in surgical patients with lung cancer at nutritional risk
STUDY DESIGN 10-week randomized controlled trial of 3 parallel arms double-blinded for supplement control CTRL multi-nutrient supplement NUT and multimodal intervention MM After baseline assessment patients will be randomized to either group in a 111 CTRLNUTMM ratio using a computer-generated randomization scheme by permuted block sizes with stratification by sex and functional capacity or 450 m on the 6-minute walk test 6MWT Consecutive adult patients or 45 years scheduled for elective video-assisted thoracic surgery or open thoracotomy surgery of non-small cell lung cancer NSCLC stages I II or IIIa and a Patient-Generated Subjective Global Assessment PG-SGA score or 3 will be approached following their first appointment with their surgeon at the McGill University Health Centre MUHC-Montreal General Hospital
INTERVENTION The NUT arm will ingest a multi-nutrient supplement consisting of whey protein leucine viatmin D and fish oil The CTRL participants will receive placebo supplements with the same physical aspect flavor and packaging as the active supplementThe MM arm will receive the NUT intervention in addition to performing structured exercise and relaxation techniques for 4 weeks prior to surgery and 6 weeks after hospital discharge
OUTCOMES Primary physical capacity measured by the 6MWT Secondary physical function muscle strength total skeletal muscle mass leg muscle volume and density body composition quality of life length of stay and post-operative complications Other dietary intake physical activity exercise tolerance pulmonary function clinical markers
STATISTICAL ANALYSIS Intention-to-treat analysis will be performed in the primary analyses For preoperative data analysis of covariance ANCOVA will compare between-group differences at 4-week preoperative time conditioned for baseline data including predefined covariates in the model age sex BMI The hypothesis of full recovery from the intervention at 6 weeks postoperative ie 6MWT returning back to or exceeding baseline will be tested by logistic regression yesno Between-group changes in other outcomes will be evaluated as differences in mean or proportions as appropriate with 95 CIs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None