(OR03-01-23) A Novel Multimodal Intervention for Surgical Prehabilitation on Functional Recovery and Muscle Characteristics in Patients With Lung Cancer – A Study Protocol

Objectives: Lung cancer is the leading cause of cancer deaths. Patients with early-stage non-small cell lung cancer (NSCLC) are candidates for surgical resection but those with reduced muscle mass, myosteatosis or malnutrition, have reduced functional capacity preoperatively and are at higher risk of postoperative mortality. Prehabilitation is a care process to enhance functional capacity before surgery to improve surgical outcomes. Our objectives are to test prehabilitation interventions of a mixed-nutrient supplement (NUT) alone and with exercise (MM, multimodal prehabilitation), compared to placebo-control (CTL), in NSCLC patients on 1) the change in functional capacity pre-surgery and 6 weeks post-discharge (primary outcome), 2) muscle mass and myosteatosis, and 3) postoperative quality of life (QoL), complications, and length of stay. We hypothesize that a novel multi-nutrient supplement, with or without exercise, will benefit patients at risk of malnutrition.

Methods: In a randomized controlled trial of 3 parallel arms, 168 patients with early-stage NSCLC at nutritional risk (Patient-Generated Subjective Global Assessment >2) will be randomized 1:1:1 to CTL, NUT or MM. For 4 weeks pre-op, the NUT and MM groups will receive a nutritional supplement of whey protein, leucine, vitamin D and fish oil. The exercise program (MM) consists of daily moderate-intensity aerobic activity and resistance training 3 times/week. The following will be assessed at baseline, week 4 pre-op and week 6 post-discharge: 1) functional capacity using the 6-minute walk test (6MWT), 2) muscle mass and myosteatosis using D3-Creatine dilution and peripheral quantitative computed tomography, respectively, and 3) QoL using the Functional Assessment of Cancer Therapy-Lung. Intention-to-treat analysis of covariance will compare between-group differences for repeated measures. Post-op functional recovery (6MWT change < 20m) will be tested by logistic regression. T-tests, Wilcoxon-Mann Whitney, or proportion tests (as appropriate) will evaluate between-group changes in clinical outcomes. Bonferroni corrections will be applied.

Results: N/A

Conclusions: Our work will benefit patients with nutrition risk and NSCLC by better preparing them for surgery, making them better candidates for treatment and improving recovery.

Funding Sources: Canadian Institutes of Health Research