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Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first line chemotherapy – a randomized controlled trial
20 September 2018 (online)
In contrast to other cancer sites, for ovarian cancer the treatment supporting effect of modifiable life style factors have not been well studied. Two side-effects of ovarian cancer that often lead to decreased QoL and reduced survival times are muscle wasting and malnutrition. As they often co-occur it is believed that a combination of nutrition counselling and exercise will be most effective. Still, randomized controlled trials are lacking. We aim to (1) evaluate the effects of a 24-months resistance exercise training and nutritional intervention during and after chemotherapy on progression-free survival (PFS) and to (2) investigate the effects on patient-reported outcomes, patients' muscle function, and maintenance of a healthy lifestyle.
The study is a 1:1 randomized controlled trial with an intervention group (IG) and control group (CG). While the IG undergo an individual exercise and nutrition program the CG receives usual care. The intervention is divided into three phases. In phase I patients receive a supervised training and nutrition counselling. In phase II and III patients continue a home-based training which is discussed with a sport scientist as well as nutrition counselling. Calculations assuming a median survival time without intervention of 17.4 months and a HR of 0.8 result in a probability of survival at three years of 31.75% with and 23.83% without intervention.
A pilot study to test the feasibility is ongoing. If successful, a multicenter study design will be used for the main trial. Positive results could lead to an enhancement of care offered to ovarian cancer patients.