Clinical trial NCT05480735: EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy
Official title: EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Carcinoma
Keywords: prehabilitation
bladder cancer
exercise
smoking cessation
nutritional support
surgical complications
cystectomy
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: University Medical Center Groningen
name: Radboud University Medical Center
name: Rijnstate Hospital
name: Noordwest Ziekenhuisgroep
name: Erasmus Medical Center
name: Maastricht University Medical Center
name: Karolinska Institutet
First posted: 2022-07-29
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Complications
timeFrame: 0-12 weeks post-surgery (measured 4 weeks and 12 weeks post-surgery)
Secondary outcomes:
measure: High grade complications
timeFrame: 0-12 weeks post-surgery
measure: Duration of hospital stay
timeFrame: 0-12 weeks post-surgery
measure: Readmissions
timeFrame: 0-12 weeks post-surgery
measure: Disease status
timeFrame: 0-12 weeks post-surgery
measure: Change in cardiorespiratory fitness
timeFrame: T0a (baseline), T1 (within 1 week before surgery)
measure: Change in muscle strength
timeFrame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
measure: Change in muscle strength
timeFrame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
measure: Change in physical performance
timeFrame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
measure: Change in nutritional status
timeFrame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
measure: Change in body composition
timeFrame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
measure: Nil per mouth consumption during hospitalization
timeFrame: 0-12 weeks post-surgery
measure: Change in weight
timeFrame: T0a (baseline), T1 (within 1 week before surgery), T3 (12 weeks post-surgery)
measure: Height
timeFrame: T0a (baseline) - T3 (12 weeks post-surgery)
measure: Change in smoking status
timeFrame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
measure: Sense of coherence (SOC)
timeFrame: T0a (baseline)
measure: Change in fatigue
timeFrame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
measure: Change in HRQoL
timeFrame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
measure: Change in muscle invasive bladder cancer specific scores
timeFrame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
measure: Change in health status
timeFrame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
measure: Change in physical activity
timeFrame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
measure: Change in anxiety and depression
timeFrame: T0a (baseline), T0b (if applicable: after neoadjuvant chemotherapy), T1 (within 1 week before surgery), T2 (4 weeks post-surgery), T3 (12 weeks post-surgery)
measure: Intervention costs
timeFrame: T0a (baseline) - T3 (12 weeks post-surgery)
measure: Healthcare resources consumption
timeFrame: 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)
measure: Work status
timeFrame: T0a (baseline) - T3 (12 weeks post-surgery)
measure: Satisfaction with prehabilitation in intervention group and evaluation in control group
timeFrame: T3 (12 weeks post-surgery)
measure: Non participation analysis
timeFrame: T0a (baseline)
measure: Hypoxia
timeFrame: T3 (12 weeks post-surgery)
Other outcomes:
measure: Overall and bladder-cancer specific survival
timeFrame: 0-60 months
measure: Progression-free survival
timeFrame: 0-60 months
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Doctor Molewaterplein 40
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Geert Grooteplein Zuid 10
city: Groningen
country: Netherlands
facility: UMC Groningen
state: Hanzeplein 1
city: Utrecht
country: Netherlands
facility: UMC Utrecht
state: Heidelberglaan 100
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Michelangelolaan 2
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
state: P. Debyelaan 25
city: Arnhem
country: Netherlands
facility: Rijnstate
state: Wagnerlaan 55
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
state: Wilhelminalaan 12
Study officials:
References: