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Effects of a combined exercise and dietary intervention on clinical outcomes in patients with ovarian cancer: the Physical Activity and Dietary intervention in OVArian cancer (PADOVA) randomized controlled trial
  1. Calvin G Brouwer1,
  2. Yvonne A W Hartman1,
  3. Stephanie Stelten1,
  4. Malou-Floor Kenkhuis1,
  5. Luc R C W van Lonkhuijzen2,
  6. Gemma G Kenter2,3,
  7. Milan Kos4,
  8. Peter M van de Ven5,
  9. Willemien J van Driel3,
  10. Renate M Winkels6,
  11. Ruud L M Bekkers7,8,9,
  12. Petronella B Ottevanger10,
  13. Meeke Hoedjes11 and
  14. Laurien M Buffart1
    1. 1Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, The Netherlands
    2. 2Department of Gynecologic Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centres, Amsterdam, The Netherlands
    3. 3Gynecology, The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands
    4. 4Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centres, Amsterdam, The Netherlands
    5. 5Department of Data Science and Biostatistics, Julius Center for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, The Netherlands
    6. 6Human Nutrition and Health, Wageningen University & Research, Wageningen, The Netherlands
    7. 7Department of Gynecology, Catharina Hospital, Eindhoven, The Netherlands
    8. 8Department of Obstetrics and Gynecology, Radboud University Medical Center, Nijmegen, The Netherlands
    9. 9Grow School for Oncology and Reproduction, Maastricht University, Maastricht, the Netherlands
    10. 10Department of Medical Oncology, Dutch Gynaecological Oncology Group (DGOG), Radboud University Medical Center, Nijmegen, The Netherlands
    11. 11Department of Medical and Clinical Psychology, CoRPS - Center of Research on Psychological and Somatic disorders, Tilburg University, Tilburg, The Netherlands
    1. Correspondence to Dr Laurien M Buffart, Department of Medical BioSciences, Radboud University Medical Center, Nijmegen, 6525GA, Netherlands; Laurien.buffart{at}radboudumc.nl

    Abstract

    Objective Chemotherapy treatment modifications can impact survival in patients with ovarian cancer, particularly when the relative dose intensity falls below 85%. Exercise and dietary interventions may benefit treatment tolerability. This study aimed to explore the effects of a combined exercise and dietary intervention on secondary outcomes of the Physical Activity and Dietary intervention in OVArian cancer (PADOVA) trial, specifically relative dose intensity and progression-free survival.

    Methods 81 patients with ovarian cancer were randomized into a combined supervised exercise and dietary intervention during (neo)adjuvant chemotherapy or a usual care control group. Relative dose intensity was calculated as the ratio of delivered dose intensity (dose per actual time) to the standard dose for six chemotherapy cycles. The effect on relative dose intensity was analyzed using logistic regression and Bayesian posterior probability of correctly identifying the best study arm. The effect on progression-free survival was examined using Cox regression.

    Results The proportion of patients achieving a relative dose intensity ≥85% was 74.4% in the intervention group compared with 61.5% in the control group (OR 2.04, 95% CI 0.75 to 5.84). The Bayesian posterior probability that the intervention group had a higher proportion of patients with a relative dose intensity ≥85% was 88.4%. Intervention effect on progression-free survival was not statistically significant (HR 1.63, 95% CI 0.82 to 3.23). At 18 months, the proportion of patients without disease progression was 73% in the intervention group and 51% in the control group.

    Conclusion The proportions of patients with ovarian cancer with a relative dose intensity ≥85% and an 18-month progression-free survival were numerically higher in the intervention group compared with the control group, but these differences were not statistically significant. The higher proportions and the 88.4% probability that intervention is superior to usual care for clinical outcomes support future studies on exercise and dietary interventions with a focus on clinical outcomes as primary endpoints.

    Trial registration number Registered in the Netherlands Trial Registry (NTR6300).

    • Ovarian Cancer

    Data availability statement

    Data are available on reasonable request. In accordance with the journal’s guidelines, we will provide our data for independent analysis by a selected team by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.

    https://doi.org/10.1136/ijgc-2024-005634

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      Data availability statement

      Data are available on reasonable request. In accordance with the journal’s guidelines, we will provide our data for independent analysis by a selected team by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.

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      Footnotes

      • Contributors LB, MH and GK conceptualized the methodology and study procedures and obtained the funding for the study. Data curation was performed by CB, YH, SS and MFK, and YH, SS and MFK performed the project administration. CB, LB (human movement scientist, epidemiologist), and PvdV (biostatistician) performed the statistical analyses. CB and LB wrote the original draft and CB visualized the results. LL, WD, RW, RB and PO provided necessary resources for the study, including patient enrollment. All authors contributed to the investigation and review and editing of the manuscript. All authors approved the final version. LB is guarantor.

      • Funding The PADOVA study is funded by the Dutch Cancer Society, grant number VU 2015–7950.

      • Competing interests None declared.

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.