Effects of Combined Exercise and Dietary Intervention on Body Composition, Physical Functioning, and Fatigue in Ovarian Cancer Patients: PADOVA Trial Results

Academic Background

Ovarian cancer is the seventh most common cancer among women, usually detected at an advanced stage, with an overall 5-year survival rate as low as 30-40%. Standard ovarian cancer treatments include cytoreductive surgery and (neo)adjuvant chemotherapy. This treatment leads to decreased physical fitness, fatigue, muscle atrophy, and malnutrition, significantly affecting patients’ health-related quality of life (HRQOL). Although previous studies have shown that exercise and dietary interventions have significant benefits on body composition, fatigue, physical fitness, and HRQOL in cancer patients, these studies have mainly focused on breast cancer patients, and it is unclear whether these results are applicable to ovarian cancer patients. Therefore, the PADOVA trial aims to assess the impact of combined exercise and dietary interventions on body composition, physical functioning, and fatigue in ovarian cancer patients during and after (neo)adjuvant chemotherapy.

Source of the Paper

The authors of this paper include Marlou-Floor Kenkhuis, Stephanie Stelten, and others from Radboud University Medical Center, Amsterdam UMC, and other institutions in the Netherlands. The paper was published in the 2024 British Journal of Cancer, titled “Effects of a combined exercise and dietary intervention on body composition, physical functioning and fatigue in patients with ovarian cancer: results of the PADOVA trial.”

Study Design and Participants

The PADOVA trial is a dual-arm multicenter randomized controlled trial, with participants randomly assigned to the intervention group and the control group. The study recruited 81 ovarian cancer patients between 2018 and 2022, randomly assigned to the combined exercise and dietary intervention group (40 patients) and the control group (41 patients). The intervention began in the first 3-week cycle of chemotherapy and continued through the last chemotherapy cycle. The study was approved by the Medical Ethics Committee of Amsterdam UMC and registered in the Netherlands Trial Registry (NTR6300).

Study Procedure

Intervention Design

The intervention included twice-weekly, 1-hour sessions of moderate-to-high intensity resistance training and aerobic exercises, supervised by oncology specialist physiotherapists. Dietary counseling was provided by specialist dietitians every three weeks through 30-45 minute face-to-face or phone consultations, using motivational interviewing techniques to ensure adequate calorie and protein intake for each patient.

Outcome Measures

The primary outcome measures were body composition, physical function, and fatigue; secondary outcomes included physical fitness, HRQOL, anxiety and depression symptoms, neuropathy symptoms, sleep disturbances, physical activity levels, and dietary intake. Measurements were taken at baseline, post-chemotherapy, and 12 weeks after chemotherapy.

Data Analysis

Data were analyzed using linear mixed models to evaluate changes over time and between-group differences. All analyses were conducted on an intention-to-treat basis, adjusting for balanced variables. Sensitivity analyses were performed to explore potential effect modifications by age, treatment regimen, and baseline values.

Study Results

Comparison Between Intervention and Control Groups

In terms of primary outcomes, body composition, physical function, and fatigue showed improvements over time in both the intervention and control groups, with fatigue decreasing; however, no significant differences were observed between the two groups. No significant differences were found in secondary outcomes either. Specific results are as follows: - Fat-free mass (FFM) increased: Both groups increased, but the difference between groups was not significant (β=−0.5 kg; 95% CI=−3.2; 2.1). - Physical function increased: Both groups showed significant improvement, but no significant difference was found between the intervention and control groups (β= 1.4; 95% CI=−5.4; 8.3). - Fatigue decreased: Both groups showed significant reductions in fatigue, but there was no significant difference between groups (β= 0.7; 95% CI=−1.5; 2.8).

Intervention Adherence and Contamination

The median attendance rate for the intervention group was 71.7%, with 16 participants attending more than 75% of the sessions. For dietary counseling, the median attendance rate was 80%, with 18 participants attending at least 75% of the counseling sessions. In the control group, five participants voluntarily attended twice-weekly exercise sessions supervised by physiotherapists.

Discussion

Although improvements in body composition, physical function, and fatigue were observed during and after chemotherapy in both the intervention and control groups, the combined exercise and dietary intervention did not show significant additional benefits over standard care. Possible reasons include: 1. Ovarian cancer patients are usually in advanced stages at diagnosis, and chemotherapy and surgery help alleviate symptoms, improving physical fitness and HRQOL; hence, additional benefits from exercise and dietary interventions may not be significant. 2. There is substantial heterogeneity in intervention effects, suggesting that certain subgroups may benefit more. 3. Adherence to the intervention and contamination in the control group may have affected the significance of the results.

Conclusion

The PADOVA trial indicates that ovarian cancer patients show improvements in body composition, physical function, and fatigue during and after chemotherapy; however, a combined exercise and dietary intervention does not provide additional benefits compared to standard care. The study emphasizes the importance of conducting specialized studies within specific cancer populations, reminding researchers to consider patients’ unique characteristics and needs when designing interventions for different cancer types.