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

Bladder Carcinoma Clinical Trial

— ENHANCE  

Official title:

EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480735
• Other study ID #: NL78792.031.22
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2022
• Est. completion date: October 2025

Study information

• Verified date: October 2022
• Source: The Netherlands Cancer Institute
• Contact: Martijn Stuiver, PhD
• Phone: +31205124136
• Email: m.stuiver[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: October 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Carcinoma
• Urinary Bladder Neoplasms

Intervention

Behavioral:
• Prehabilitation
Multimodal prehabilitation program

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar	Wilhelminalaan 12
Netherlands	Rijnstate	Arnhem	Wagnerlaan 55
Netherlands	Catharina Ziekenhuis	Eindhoven	Michelangelolaan 2
Netherlands	UMC Groningen	Groningen	Hanzeplein 1
Netherlands	Maastricht UMC+	Maastricht	P. Debyelaan 25
Netherlands	Radboudumc	Nijmegen	Geert Grooteplein Zuid 10
Netherlands	Erasmus Medical Center	Rotterdam	Doctor Molewaterplein 40
Netherlands	UMC Utrecht	Utrecht	Heidelberglaan 100

Sponsors (9)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Erasmus Medical Center, Karolinska Institutet, Maastricht University Medical Center, Noordwest Ziekenhuisgroep, Radboud University Medical Center, Rijnstate Hospital, UMC Utrecht, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall and bladder-cancer specific survival	Exploratory outcome	0-60 months
Other	Progression-free survival	Exploratory outcome	0-60 months
Primary	Complications	The proportion of patients having Clavien-Dindo grade 2 or higher perioperative complications; obtained from the medical records	0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)
Secondary	High grade complications	Clavien Dindo grade 3 or higher	0-12 weeks post-surgery
Secondary	Duration of hospital stay	Time from admission until hospital discharge	0-12 weeks post-surgery
Secondary	Readmissions	Hospital readmission as recorded in medical file	0-12 weeks post-surgery
Secondary	Disease status	Progression/recurrence, any additional treatment as recorded in medical file	0-12 weeks post-surgery
Secondary	Change in cardiorespiratory fitness	Assessed via cardiopulmonary exercise test (CPET)	T0a (baseline), T1 (within 1 week before surgery)
Secondary	Change in muscle strength	Grip strength	T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Secondary	Change in muscle strength	30s chair stands	T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Secondary	Change in physical performance	Short Physical Performance Battery (SPPB)	T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Secondary	Change in nutritional status	Short Form- Patient Generated Subjective Global Assessment (SF-PGSA)	T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Secondary	Change in body composition	Fat free mass and fat mass assessed by Scale Bioelectrical Impedance Analysis (BIA)	T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Secondary	Nil per mouth consumption during hospitalization	The total days as recorded in medical file	0-12 weeks post-surgery
Secondary	Change in weight	Measured in KG	T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
Secondary	Height	Measured in cm	T0a (baseline) - T3 (12 weeks post-surgery)
Secondary	Change in smoking status	Self-developed questionnaire	T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Secondary	Sense of coherence (SOC)	13-item SOC questionnaire	T0a (baseline)
Secondary	Change in fatigue	MFI questionnaire	T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Secondary	Change in HRQoL	EORTC QLQ-C30	T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Secondary	Change in muscle invasive bladder cancer specific scores	EORTC QLQ-BLM30	T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Secondary	Change in health status	EQ-5D-5L	T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Secondary	Change in physical activity	SQUASH questionnaire	T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Secondary	Change in anxiety and depression	HADS questionnaire	T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
Secondary	Intervention costs	Cost analysis	T0a (baseline) - T3 (12 weeks post-surgery)
Secondary	Healthcare resources consumption	Medical Consumption Questionnaire (iMCQ)	T0a (baseline) - T3 (12 weeks post-surgery) (measured within 1 week before surgery, 4 and 12 weeks post-surgery and if applicable : after neoadjuvant chemotherapy)
Secondary	Work status	Productivity Cost Questionnaire (iPCQ)	T0a (baseline) - T3 (12 weeks post-surgery)
Secondary	Satisfaction with prehabilitation in intervention group and evaluation in control group	Self-developed questionnaire	T3 (12 weeks post-surgery)
Secondary	Non participation analysis	Identify clinical and sociodemographic variables that are related to non-participation of patients in this trial via questionnaire	T0a (baseline)
Secondary	Hypoxia	To study the effectiveness of the prehabilitation program in terms of inducing favorable changes in tumor hypoxia markers	T3 (12 weeks post-surgery)