A multicentre, open, randomized phase II study comparing a multimodal intervention (oral nutritional supplements, celecoxib and physical exercise) for cachexia versus standard cancer care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
46
Nutritional supplements aimed at optimal energy balance and protein intake (2 cartons of ProSure per day), nutritional advice, home-based self-assisted exercise program and anti-inflammatory treatment (300 mg celecoxib) for 6 weeks. The aerobic exercise program is performed as self-administered daily walking sessions, aiming for a minimum of two sessions 30 minutes on a weekly basis. Other aerobic activities could be used instead of walking. The resistance exercise program should be performed 3 times weekly and lasts about 20 minutes. The program is targeting major muscle groups in the upper body and legs with use of weights. The intensity of the exercise and performance of the exercises are adapted to the individual patient's disease burden and physical performance.
Standard cancer care
Oslo University Hospital Ullevål
Oslo, Norway
St Olavs Hospital
Trondheim, Norway
University of Edinburgh
Edinburgh, United Kingdom
Feasibility of recruitment and retention
The aim of this study is to investigate the feasibility of the multimodal intervention for cancer cachexia by assessing; enrolment rate, compliance with study intervention, contamination-rate in the control group with respect to any of the interventions.
Time frame: 12 weeks
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