The effect of individualized NUTritional counseling on muscle mass and treatment outcome in patients with metastatic COLOrectal cancer undergoing chemotherapy: a randomized controlled trial protocol

Table 1 Outcome measures

Measurement	Instrument	Time point*
Primary outcome
Skeletal muscle area	CT (skeletal muscle area L3)	T0, T1
Secondary outcomes
Skeletal muscle area	CT (skeletal muscle area L3)	T0, T2
Quality of life	EORTC QLQ C30 (global health- and physical functioning domain)	T0, T1, T2
Hand grip strength	Hydraulic hand dynamometer	T0, T1, T2
Treatment toxicity	Common Toxicity Criteria version 4.0	ESP
Treatment intensity	Dose index and time index of chemotherapy	ESP
Adverse events	Medical record	ESP
Treatment response	Response Evaluation Criteria In Solid Tumors (RECIST)	T1, T2
Progression free and overall survival	Medical record or general practitioner office	After 2 years

*T0: prior to chemotherapy; T1: after three cycles of CAPOX(−B) or four cycles of FOLFOX(−B); T2: after six cycles of CAPOX(−B) or eight cycles of FOLFOX(−B); ESP: entire study period.
CT: Computed Tomography; EORTC QLQ: The European Organisation for Research and Treatment of Cancer: Quality of life questionnaire. L3: third lumbar vertebra.

ISSN: 1471-2407