Physical Activity and Dietary intervention in OVArian cancer (PADOVA): a RCT evaluating effects on body composition, physical function, and fatigue

As a consequence of the disease and its treatment, many women with ovarian
cancer perceive physical and psychological problems compromising their quality
of life. Physical activity and diet are energy balance related behaviours
linked to body composition and have been associated with improved physical
function and quality of life, as well as reduced fatigue. In addition, regular
physical activity, a healthy diet and body weight have been associated with
increased survival. Current knowledge of the effect of physical activity and
dietary interventions on health outcomes generally relies on studies among
breast cancer survivors treated with curative intent. Except for a few pilot
studies indicating that lifestyle interventions are safe and feasible, no
studies have focused on women with ovarian cancer. Ovarian cancer has a very
distinct disease and treatment trajectory as it is often detected at an
advanced stage. It is not known whether findings from studies among breast
cancer are generalizable to women with ovarian cancer, thus a well-designed
randomized controlled trial is needed.
The intervention of the PADOVA study is expected to be beneficial for
participants (e.g., it is expected the intervention will lead to improvements
in body composition, physical function, and fatigue).
Results of the PADOVA study will contribute to further development and
implementation of interventions for women with ovarian cancer.

This single blind randomized controlled trial evaluates the effects of a
combined supervised exercise and dietary intervention during chemotherapy
treatment on body composition, physical function and fatigue (primary
outcomes). Secondary outcomes include physical activity and fitness, BMI, diet,
health-related quality of life and symptoms related to ovarian cancer and its
treatment (pain, fatigue, nausea/vomiting, neuropathy), anxiety and depression,
sleep disturbances and chemotherapy completion rates.
Additionally, an extensive process evaluation will be conducted to examine how
and why the intervention was (un)successful and blood will be drawn for future
analyses to examine biological mechanisms linking exercise to clinical
outcomes, such as reduced inflammation, improved immune function,
vascularization and perfusion, and insulin-like growth factor-axis.

This will be a single blind, randomized, multi-center study. After baseline
measurements participants will be randomized in either the intervention or the
waitlist control group. Study parameters will be assessed before start of
chemoterapy (T0), after finishing chemotherapy (T1) and 12 weeks later (T2).

The intervention group will receive a supervised exercise and dietary
intervention during chemotherapy treatment (18 weeks). Supervised one-hour
exercise sessions include aerobic and resistance exercises and will be given
twice a week. Tailored dietary counselling is provided by experienced
oncological dieticians during face-to-face sessions once every three weeks,
aiming to meet dietary recommendations for cancer survivors and to prevent
undesired weight gain or weight loss.
Women in the wait-list control group will receive, upon request, three
counselling sessions (during 12 weeks) with a dietitian and/or physical
therapist after completion of chemotherapy treatment and the first follow-up
assessment.

Previously conducted pilot studies indicate that lifestyle interventions are
safe and feasible in patients with ovarian cancer during chemotherapy. The
intervention is expected to be beneficial for participants (e.g., it is
expected the intervention will lead to improvements in body composition,
physical function, and fatigue).
Participation is expected not to cause any additional risks. Venepuncture can
cause hemorrhage, the questionnaires could contain confronting questions and
incidental findings from the measurements (e.g. arrhythmia) will be reported to
the physician. These risks are also described in the patient information
letter. The risk of participating in the endurance and strength tests is
considered as minimal as participants will be supervised by a trained
professional. Tailered counselling will be given by a dietitian or physical
therapist specialized in oncology. Futhermore, participation in this trial is
expected not to cause any risks.

Meaurements for study outcomes will be conducted in the hospital. Participants
will visit the hospital three times over the course of 30 weeks, one visit will
take 2 hours. During each of these visits, blood will be drawn and a physical
examination (cardiorespiratory fitness, muscle strength, length, weight and
body composition) will be conducted. Additionally participants are asked to
wear a accelerometer on the right hip for seven consecutive days. A
accelerometer is a small light-weight device which detects accelerations.
Questionnaires can be filled in at home, one questionnaire will take up
approximately 60 minutes to complete.

Participants in the intervention group wll visit the physical therapist twice a
week and the dietician once every three weeks. Participants in the control
group will visit a dietitian and/or physical therapist if they wish to do so
(with a maximum of three sessions per clinician).