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EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy

NCT ID: NCT05480735

Last Updated: 2022-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-11

Study Completion Date

2025-10-31

Brief Summary

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Currently, the potential value of a multimodal prehabilitation program in bladder cancer has not been extensively studied. The investigators designed the ENHANCE study to assess the effect of a structured multimodal prehabilitation program in 154 patients with bladder cancer on the number (primary endpoint) and severity of complications within 90 days, length of hospital stay, readmissions, physical fitness, muscle strength, physical functioning, nutritional status, smoking behaviour, anxiety and depression, fatigue, quality of life, physical activity, tumor tissue characteristics, and healthcare costs.

Detailed Description

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The ENHANCE study is a multicenter, randomized controlled trial. The intervention group will participate in a prehabilitation program of 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The prehabilitation program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. Patients will be asked to be physically active for an additional 2 times a week for at least 30 minutes. A dietician will provide nutritional support and give dietary advice to increase protein intake to enhance the anabolic effect on muscle mass. Additionally, patients will receive a supplement containing 30 g of high quality whey-protein daily preferably before sleep and after the supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychological support. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke. Patients in the intervention group will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation. The physical activity level in both groups will be obtained via questionnaire.

Conditions

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Bladder Carcinoma

Keywords

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prehabilitation bladder cancer exercise smoking cessation nutritional support surgical complications cystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prehabilitation group

The intervention group will participate in a prehabilitation program of approximately 4-6 weeks before surgery, and additionally during neoadjuvant chemotherapy if applicable. The program consist of a tailored exercise program, nutritional support and if relevant smoking cessation and/or psychological counselling. The exercise program is under supervision of an oncology specialized physiotherapist and comprises aerobic-, resistance- and breathing- and relaxation exercises. A dietician will provide nutritional support and give dietary advice to increase protein intake, including a supplement containing 30 g of whey-protein daily and after supervised training. Patients who score high on anxiety and depression will be offered a referral to a psychologist. Intensive counselling and nicotine replacement therapy will be offered to all patients who smoke.

Patients will be asked to keep a diary to track unsupervised activity and to track intake of the protein supplementation.

Group Type EXPERIMENTAL

Prehabilitation

Intervention Type BEHAVIORAL

Multimodal prehabilitation program

Control group

Patients randomized to the control group will receive care as usual according to local ERAS guideline implementation. In addition, they will receive a leaflet with the recent guidelines regarding physical activity, dietary advice, and smoking cessation. Their actual physical activity level will be obtained via questionnaire.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Prehabilitation

Multimodal prehabilitation program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UMC Utrecht

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role collaborator

Rijnstate Hospital

OTHER

Sponsor Role collaborator

Noordwest Ziekenhuisgroep

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Erasmus Medical Center

Rotterdam, Doctor Molewaterplein 40, Netherlands

Site Status RECRUITING

Radboudumc

Nijmegen, Geert Grooteplein Zuid 10, Netherlands

Site Status RECRUITING

UMC Groningen

Groningen, Hanzeplein 1, Netherlands

Site Status RECRUITING

UMC Utrecht

Utrecht, Heidelberglaan 100, Netherlands

Site Status RECRUITING

Catharina Ziekenhuis

Eindhoven, Michelangelolaan 2, Netherlands

Site Status RECRUITING

Maastricht UMC+

Maastricht, P. Debyelaan 25, Netherlands

Site Status RECRUITING

Rijnstate

Arnhem, Wagnerlaan 55, Netherlands

Site Status RECRUITING

Noordwest Ziekenhuisgroep

Alkmaar, Wilhelminalaan 12, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Martijn Stuiver, PhD

Role: CONTACT

Phone: +31205124136

Email: [email protected]

Emine Akdemir, MSc

Role: CONTACT

Phone: +31683395101

Email: [email protected]

Facility Contacts

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Joost Boormans

Role: primary

Toine van der Heijden

Role: primary

Annemarie Leliveld

Role: primary

Anne M. May, Prof. dr.

Role: primary

Evert Koldewijn

Role: primary

Bart Bongers

Role: primary

Carl Wijburg

Role: primary

Siebe Bos

Role: primary

References

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Akdemir E, Sweegers MG, Vrieling A, Rundqvist H, Meijer RP, Leliveld-Kors AM, van der Heijden AG, Rutten VC, Koldewijn EL, Bos SD, Wijburg CJ, Marcelissen TAT, Bongers BC, Retel VP, van Harten WH, May AM, Groen WG, Stuiver MM. EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial. BMJ Open. 2023 Mar 7;13(3):e071304. doi: 10.1136/bmjopen-2022-071304.

Reference Type DERIVED
PMID: 36882246 (View on PubMed)

Other Identifiers

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NL78792.031.22

Identifier Type: -

Identifier Source: org_study_id