Study protocol of an exercise and nutrition intervention for ovarian cancer patients during and after first line chemotherapy – a randomized controlled trial

Objective:

In contrast to other cancer sites, for ovarian cancer the treatment supporting effect of modifiable life style factors such as nutrition and physical activity on survival or quality of life (QoL) have not been well studied. Two side-effects of ovarian cancer and its treatment 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 to show benefits of a combined intervention are lacking. We aim to (1) evaluate the effects of a 24-months individual resistance exercise training and nutritional intervention during and after chemotherapy on progression-free survival (PFS) after three years and (2) to investigate the effects on patient-reported outcomes (e.g. QoL, nutrition habits), patients' muscle function, and maintenance of a healthy lifestyle.

Method:

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 program and nutrition counselling the CG receives usual care. The intervention is divided into three phases. In phase I patients receive a supervised training twice a week and nutrition counselling every three weeks. In phase II and III patients continue a home-based training which is regularly adapted and discussed with a sport scientist as well as nutrition counselling focusing on a Mediterranean diet. Measurements will be before start of chemotherapy and intervention (baseline, T0), at week 19 (T1), after completion of chemotherapy (T2), at 12 months (T3), and at 24 months (T4). Patients are followed-up for further 12 months (T5). Power of the main study will be calculated according to a log-rank test of the treatment effect on PFS (primary analysis). Calculations assuming an exponential distribution, a median survival time without intervention of 17.4 months, an average observation period of at least three years, and a HR of 0.8, result in a probability of survival at three years of 31.75% with and 23.83% without intervention. Assuming 80% power, a 5% significance level, and a drop-out rate of 10%, 955 patients have to be recruited.

Results:

A pilot study (n = 30) 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.