Predicting muscle loss during lung cancer treatment (PREDICT): protocol for a mixed methods prospective study.

Introduction: Low muscle mass and low muscle attenuation (radiodensity), reflecting increased muscle adiposity, are prevalent muscle abnormalities in people with lung cancer receiving curative intent chemoradiation therapy (CRT) or radiation therapy (RT). Currently, there is a limited understanding of the magnitude, determinants and clinical significance of these muscle abnormalities in the lung cancer CRT/RT population. The primary objective of this study is to identify the predictors of muscle abnormalities (low muscle mass and muscle attenuation) and their depletion over time in people with lung cancer receiving CRT/RT. Secondary objectives are to assess the magnitude of change in these parameters and their association with health-related quality of life, treatment completion, toxicities and survival.
Methods and Analysis: Patients diagnosed with lung cancer and planned for treatment with CRT/RT are invited to participate in this prospective observational study, with a target of 120 participants. The impact and predictors of muscle abnormalities (assessed via CT at the third lumbar vertebra) prior to and 2 months post CRT/RT on the severity of treatment toxicities, treatment completion and survival will be assessed by examining the following variables: demographic and clinical factors, weight loss, malnutrition, muscle strength, physical performance, energy and protein intake, physical activity and sedentary time, risk of sarcopenia (Strength, Assistance in walking, Rise from a chair, Climb stairs, Falls history (SARC-F) score alone and with calf-circumference) and systemic inflammation. A sample of purposively selected participants with muscle abnormalities will be invited to take part in semistructured interviews to understand their ability to cope with treatment and explore preference for treatment strategies focused on nutrition and exercise.
Ethics and Dissemination: The PREDICT study received ethics approval from the Human Research Ethics Committee at Peter MacCallum Cancer Centre (HREC/53147/PMCC-2019) and Deakin University (2019-320). Findings will be disseminated through peer review publications and conference presentations.
Competing Interests: Competing interests: NKK reports grants from Victorian Cancer Agency, during the conduct of the study. AU reports grants from Victorian Cancer Agency, during the conduct of the study. RMD reports grants from World Cancer Research Fund International Regular Grant Programme, outside the submitted work. DB reports personal fees from Astra Zeneca, outside the submitted work. NH reports grants from Varian Medical Systems, outside the submitted work. SS reports personal fees from Astra Zeneca, outside the submitted work. CMP reports personal fees from Abbott Nutrition, Nutricia, Nestle Health Science, Fresenius Kabi and Pfizer, outside the submitted work. AW, GA, LD, LE and SE have nothing to disclose.
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