Abstract
Background: New clinical trials in cancer cachexia are essential, and outcome measures with high responsiveness to detect meaningful changes are crucial. This secondary analysis from a multimodal intervention trial estimates sensitivity to change and between treatment effect sizes (ESs) of outcome measures associated with body composition, physical function, metabolism, and trial intervention.Methods: The study was a multicenter, open-label, randomized pilot study investigating the feasibility of a 6-week multimodal intervention [exercise, non-steroidal anti-inflammatory drugs, and oral nutritional supplements containing polyunsaturated fatty acids (n−3 PUFAs)] vs. standard cancer care in non-operable non-small-cell lung cancer and advanced pancreatic cancer. Body composition measures from computerized tomography scans and circulating biomarkers were analyzed.Results: Forty-six patients were randomized, and the analysis included 22 and 18 patients in the treatment and control groups, respectively. The between-group ESs were high for body weight (ES = 1.2, p < 0.001), small for body composition and physical function [handgrip strength (HGS)] measures (ES < 0.25), moderate to high for n-3 PUFAs and 25-hydroxyvitamin D (25-OH vitamin D) (ES range 0.64–1.37, p < 0.05 for all), and moderate for serum C-reactive protein (ES = 0.53, p = 0.12). Analysis within the multimodal treatment group showed high sensitivity to change for adiponectin (ES = 0.86, p = 0.001) and n-3 PUFAs (ES > 0.8, p < 0.05 for all) and moderate for 25-OH vitamin D (ES = 0.49, p = 0.03). In the control group, a moderate sensitivity to change for body weight (ES = −0.84, p = 0.002) and muscle mass (ES = −0.67, p = 0.016) and a high sensitivity to change for plasma levels of 25-OH vitamin D (ES = −0.88, p = 0.002) were found.Conclusion: Demonstrating high sensitivity to change and between treatment ES and body composition measures, body weight still stands out as a clinical and relevant outcome measure in cancer cachexia. Body composition and physical function measures clearly are important to address but demand large sample sizes to detect treatment group differences.Trial registration: ClinicalTrials.gov identifier: NCT01419145.
Highlights
Cancer cachexia is a complex multifactorial syndrome resulting in progressive weight loss due to loss of skeletal muscle mass with or without depletion of adipose tissue, leading to progressive loss of physical function [1]
Mean (SD) change in body weight from baseline to week 6 within the two groups showed a small increase within the treatment arm [1.0 (2.5), p = 0.08, ESWG = 0.40] and a moderate, significant decrease within the control group [−2.1 (2.5), p = 0.002, ESWG = −0.84] (Table 2)
When analyzing body composition measures (Table 2), significant time change was found for skeletal muscle mass index, which decreased within the control group (−1.8 cm2/m2, p = 0.016, ESWG = −0.67; Table 2)
Summary
Cancer cachexia is a complex multifactorial syndrome resulting in progressive weight loss due to loss of skeletal muscle mass with or without depletion of adipose tissue, leading to progressive loss of physical function [1]. Candidate outcome measures should be responsive to change, which implies that they need to be specific to the cachexia pathophysiology Such outcome measures should not be significantly influenced by other factors contributing to wasting, such as antineoplastic therapy or immobilization. New clinical trials in cancer cachexia are essential, and outcome measures with high responsiveness to detect meaningful changes are crucial. This secondary analysis from a multimodal intervention trial estimates sensitivity to change and between treatment effect sizes (ESs) of outcome measures associated with body composition, physical function, metabolism, and trial intervention
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
