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NCT05671094
Implementation of a Multimodal Prehabilitation Program in Robotic Oncological Surgery
NA trial testing Prehabilitation in Prostate Cancer in 21 participants. Completed in 31 December 2024.
19 December 2023
Quick facts
| Lead sponsor | Jessa Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 21 |
| Start date | 13 January 2023 |
| Primary completion | 19 December 2023 |
| Estimated completion | 31 December 2024 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Prehabilitation
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
- Gynecologic Cancer — all drugs for Gynecologic Cancer →
Sponsor
Jessa Hospital
Who can join
18 and older, any sex, with Prostate Cancer or Gynecologic Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Current literature on prehabilitation is broad and heterogenous. Ploussard et al initiated a multimodal one-day prehabilitation program in patients before robotic radical prostatectomy involving urology nurses, anaesthetic nurses, oncology nurse specialists, anesthesiologists, dieticians, physiotherapists etc, and observed significant improvement in terms of reduction in length of stay, blood loss, and operative time, and an increase in the proportion of ambulant surgery. Santa Mina et al observed that patients following a home-based moderate-intensity exercise prehabilitation program prior to radical prostatectomy were more fit i.e have a greater score on the 6 minutes' walk test, four weeks postoperatively compared to a control group. Regrettably, this study couldn't demonstrate a difference in length of stay or complication rate. To date, evidence for efficacy of prehabilitation in gynaecological cancer patients is limited. Several reviews and a meta-analysis indicate that the level of evidence suggesting that prehabilitation may improve postoperative outcomes is low. Moreover, there is a wide variability in applied preoperative prehabilitation programs i.e, with a uni- or multimodal approach, home-based or supervised, differences in intensity and a variety of outcomes. Therefore, there is a need for randomized controlled trials with low risk of bias and clearly defined outcome parameters to clarify the potential benefit of prehabilitation for patients Hence, the primary goal of this randomized pilot study is to determine the feasibility of the implementation of a multimodal prehabilitation program in patients undergoing robotic oncologic urological or gynaecological surgery in a Belgian tertiary center in terms of protocol adherence and recruitment rate.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05671094
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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- NCT06874413 — Targeted Prehabilitation With Physical Exercise and Inspiratory Muscle Training for Elderly Frail Patients Prior to Vent · NA · enrolling by invitation
- NCT06830967 — Virtual Prehabilitation for Patients Undergoing Abdominal Aortic Aneurysm Repair · NA · not yet recruiting
- NCT06716437 — Prehabilitation for Patients Undergoing Lung Cancer Surgery · NA · recruiting
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
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- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other Jessa Hospital trials
Trials by the same sponsor.
- NCT07483775 — Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Sur · NA · not yet recruiting
- NCT06881602 — Remote Clinical Monitoring After Robotic Distal Pancreatectomy · NA · not yet recruiting
- NCT07010055 — Using Digital Health in a Postoperative Setting After Major Surgery: Semi-structured Interview Study · NA · not yet recruiting
- NCT07010081 — Using Digital Health in a Postoperative Setting After Major Surgery: Survey Study · NA · recruiting
- NCT07482267 — Evaluation of Patients Suffering From Polytrauma Admitted to the ICU · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05671094 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jessa Hospital
- Last refreshed: 14 May 2025
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing