Abstract
Background: Muscle mass and physical function (PF) are common co-primary endpoints in cancer cachexia trials, but there is a lack of data on how these outcomes interact over time. The aim of this secondary analysis of data from a trial investigating multimodal intervention for cancer cachexia (ClinicalTrials.gov: NCT01419145) is to explore whether changes in muscle mass and PF are associated with weight loss and cachexia status at baseline. Methods: Secondary analysis was conducted using data from a phase II randomized controlled trial including 46 patients with stage III–IV non-small cell lung cancer (n = 26) or inoperable pancreatic cancer (n = 20) due to commence chemotherapy. Cachexia status at baseline was classified according to international consensus. Muscle mass (assessed using computed tomography (CT)) and PF outcomes, i.e., Karnofsky performance status (KPS), self-reported PF (self-PF), handgrip strength (HGS), 6-minute walk test (6MWT), and physical activity (PA), were measured at baseline and after six weeks. Results: When compared according to cachexia status at baseline, patients with no/pre-cachexia had a mean loss of muscle mass (−5.3 cm2, p = 0.020) but no statistically significant change in PF outcomes. Patients with cachexia also lost muscle mass but to a lesser extent (−2.8 cm2, p = 0.146), but demonstrated a statistically significant decline in PF; KPS (−3.8 points, p = 0.030), self-PF (−8.8 points, p = 0.027), and HGS (−2.7 kg, p = 0.026). Conclusions: Weight loss history and cachexia status at baseline are of importance if one aims to detect changes in PF outcomes in cancer cachexia trials. To improve the use of co-primary endpoints that include PF in future trials, outcomes that have the potential to detect change relative to weight loss should be investigated further.
Highlights
Cancer cachexia is a highly prevalent metabolic wasting syndrome characterized by involuntary weight loss, accompanied with a progressive loss of skeletal muscle mass as a key diagnostic criterion [1].The condition cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment, reduced quality of life and increased mortality [2]
We observed that patients who were in early stage of cachexia at baseline had a significant decline in muscle mass during the trial, yet without corresponding changes in physical function (PF)
Our findings support the hypothetical model proposed by Ramage et al [15] suggesting that along the trajectory of cancer cachexia, there might be a variable impact on PF outcomes depending on the magnitude of weight loss
Summary
Cancer cachexia is a highly prevalent metabolic wasting syndrome characterized by involuntary weight loss, accompanied with a progressive loss of skeletal muscle mass as a key diagnostic criterion [1].The condition cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment, reduced quality of life and increased mortality [2]. Multiple clinical trials aim to attenuate this condition [4,5,6,7] These trials measure the effects of interventions using outcomes that capture changes in key cachexia domains, including body weight or muscle mass and physical function (PF) [8]. Muscle mass and physical function (PF) are common co-primary endpoints in cancer cachexia trials, but there is a lack of data on how these outcomes interact over time The aim of this secondary analysis of data from a trial investigating multimodal intervention for cancer cachexia (ClinicalTrials.gov: NCT01419145) is to explore whether changes in muscle mass and PF are associated with weight loss and cachexia status at baseline.
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