Background Data on the treatment-supporting effect of modifiable lifestyle factors such as nutrition and physical activity on survival or quality of life (QoL) are scarce in patients with ovarian cancer. Despite a strong rationale for evaluating the effect of a multimodal intervention and multiple studies targeting other cancer sites, randomized controlled trials (RCTs) on the effects of a combined nutrition and exercise intervention on survival and QoL in ovarian cancer patients are rare. No study has investigated the impact of an early intervention during first-line chemotherapy.
Primary Objectives To evaluate the study design, feasibility, safety, and acceptance of combined nutrition and exercise in patients diagnosed with ovarian cancer during and after first-line chemotherapy.
Study Hypothesis Physical exercise and a cancer-specific nutrition intervention after ovarian cancer diagnosis is feasible, accepted, and safe for patients receiving first-line chemotherapy.
Trial Design A 1:1 RCT with an intervention group and a control group. The intervention group receives an exercise and nutrition program whereas the control group continues to follow the usual care.
Major Inclusion/Exclusion Criteria Inclusion: women ≥18 years of age; women diagnosed with ovarian cancer, tubal cancer, or peritoneal cancer and primary or interval debulking surgery. Exclusion: Eastern Cooperative Oncology Group (ECOG) status of 2 or worse.
Primary Endpoints Recruitment rate, completion rate, side effects, and adherence.
Sample Size n=30 patients (15 per arm) will be recruited.
Estimated Dates for Completing Accrual and Presenting Results Accrual completion is planned for the end of 2019. Results will be presented in the months following study completion 1 year after recruitment has been finalised.
Trial Registration Number The pilot phase was approved by the ethics committee of the Medical Faculty of Hamburg on December 13, 2017 (PV5456). The study was registered on September 9, 2018 at the German Study Registry for Clinical Studies (DRKS00013231).
- ovarian cancer
- randomised controlled trial
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Correction notice Since this article was first published, minor edits have been made to the author names
B Schmalfeldt and A Jaeger.
Contributors TM, JvG, SP, AS, BS, B-CZ, and JC-C contributed to study conception and design. TM, JvG, AJ, and LOF contributed to data and sample collection. JC-C obtained funding for the pilot project. TM and JC-C drafted the first version of the manuscript. TM is responsible for data management of the pilot study. HB performed the sample size calculations and supervised the randomization process. All authors revised the protocol critically for important intellectual content and read and approved the final version of the protocol.
Funding This study was funded by Hamburger Krebsgesellschaft.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data cannot be made publicly available for legal reasons. Due to data privacy rules and according to German law (§ 75 SGB X) access to the data is granted only to responsible scientific personnel at UKE, Hamburg, Germany within the framework of the respective research project. It is not permitted to give third parties access to the data without a proposal approved by the principal investigator.