Prehabilitation program for bladder cancer patients before surgery
EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial
NA · The Netherlands Cancer Institute · NCT05480735
This study is testing a special program that includes exercise, nutrition, and support to help bladder cancer patients get stronger and healthier before their surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 154 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute (other) |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Rotterdam, Doctor Molewaterplein 40 and 7 other locations) |
| Trial ID | NCT05480735 on ClinicalTrials.gov |
What this trial studies
The ENHANCE study evaluates the effectiveness of a structured multimodal prehabilitation program for patients with bladder cancer scheduled for cystectomy. This multicenter, randomized controlled trial involves a 4-6 week intervention that includes tailored exercise, nutritional support, and psychological counseling if needed. Participants will engage in supervised physical activities and receive dietary advice to enhance muscle mass, alongside support for smoking cessation. The study aims to assess various outcomes, including complications, hospital stay length, and overall quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed bladder cancer who are scheduled for radical cystectomy.
Not a fit: Patients with severe cognitive or psychiatric disorders, or those unable to participate in exercise training, may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce surgical complications and improve recovery outcomes for bladder cancer patients.
How similar studies have performed: Other studies have shown promising results with prehabilitation approaches in various surgical populations, suggesting potential success for this novel application in bladder cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed, primary, bladder cancer (cTa-4N0/N+M0), * Planned to undergo radical cystectomy, * Age ≥ 18 years. Exclusion Criteria: * Subjects with severe cognitive or psychiatric disorders, * Subjects who are operated within 3 weeks, * Subjects with insufficient command of the Dutch language, which precludes them from following study instructions or completing study questionnaires, * Subjects who have contraindications to safely perform exercise training or testing (i.e., CPET), * Subject who are unable or unwilling to participate in the intervention.
Where this trial is running
Rotterdam, Doctor Molewaterplein 40 and 7 other locations
- Erasmus Medical Center — Rotterdam, Doctor Molewaterplein 40, Netherlands (RECRUITING)
- Radboudumc — Nijmegen, Geert Grooteplein Zuid 10, Netherlands (RECRUITING)
- UMC Groningen — Groningen, Hanzeplein 1, Netherlands (RECRUITING)
- UMC Utrecht — Utrecht, Heidelberglaan 100, Netherlands (RECRUITING)
- Catharina Ziekenhuis — Eindhoven, Michelangelolaan 2, Netherlands (RECRUITING)
- Maastricht UMC+ — Maastricht, P. Debyelaan 25, Netherlands (RECRUITING)
- Rijnstate — Arnhem, Wagnerlaan 55, Netherlands (RECRUITING)
- Noordwest Ziekenhuisgroep — Alkmaar, Wilhelminalaan 12, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Martijn Stuiver, PhD
- Email: m.stuiver@nki.nl
- Phone: +31205124136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Carcinoma, prehabilitation, bladder cancer, exercise, smoking cessation, nutritional support, surgical complications, cystectomy