Prehabilitation for Bladder Cancer Surgery

(Prehab Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Opioids, Chemotherapy, Illicit drugs, others

Disqualifiers: Metastatic cancer, Heart failure, Severe dementia, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this research is to validate the prehabilitation program which is defined as a set of interventions meant to prepare the body physically and nutritionally for the cystectomy procedure.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have taken more than three doses of opioids within 7 days before surgery and should not be undergoing chemotherapy for bladder cancer within 1 month of surgery.

What data supports the effectiveness of the treatment Prehabilitation for Bladder Cancer Surgery?

Research shows that prehabilitation, which includes exercise and nutritional interventions, can improve strength and functional capacity in patients undergoing bladder cancer surgery. Studies indicate that these programs are feasible and can help prevent or reduce the decline in physical function that often occurs after major surgeries like radical cystectomy. ^{1 2 3 4 5}

Is prehabilitation safe for bladder cancer surgery patients?

Prehabilitation, which includes exercise and nutritional interventions, has been studied for its safety and feasibility in patients undergoing bladder cancer surgery. While the evidence is still emerging, these programs are generally considered safe and aim to improve patients' physical condition before surgery, potentially reducing complications. ^{3 5 6 7 8}

How is the treatment 'Patient-Centered Surgical Prehabilitation' different from other treatments for bladder cancer surgery?

Patient-Centered Surgical Prehabilitation is unique because it focuses on preparing patients before surgery to improve their physical condition and recovery, rather than treating the cancer directly. This approach uses the time before surgery to enhance strength and functional capacity, which can help reduce the negative effects of surgery and improve overall recovery. ^{2 3 4 8 9}

Research Team

Eligibility Criteria

This trial is for adults aged 18-85 with bladder cancer who are fit enough for surgery (ASA class 1-4) and planning to undergo cystectomy. Participants must understand and consent to the study, not have metastatic cancer, severe organ impairment, or be on certain medications. Pregnant women and those not using birth control are excluded.

Inclusion Criteria

I am between 18 and 85 years old.

My health is rated between 1 to 4 on the ASA scale.

I am a candidate for bladder removal surgery, including creating a new way for urine to leave my body.

Exclusion Criteria

I have no past surgeries, illnesses, or behaviors that could affect the study.

I do not speak English.

I haven't had chemotherapy for bladder cancer in the last month, but previous treatments are okay.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a set of investigational interventions including exercise testing, exercise training, nutritional support, and clinical assessment of nutritional status to prepare for cystectomy

4-8 weeks

Surgery and Immediate Recovery

Participants undergo cystectomy or bladder removal surgery and immediate post-operative recovery

30 days

Follow-up

Participants are monitored for safety and effectiveness after surgery, including hospitalization days, complications, and readmissions

60 months

Treatment Details

Interventions

• Exercise Training (Behavioural Intervention)
• Nutritional Intervention (Behavioural Intervention)
• Patient-Centered Surgical Prehabilitation (Behavioural Intervention)

Trial Overview The trial tests a prehabilitation program combining exercise training and nutritional intervention designed to prepare patients physically and nutritionally for bladder removal surgery (cystectomy).

Participant Groups

Group I: Standard treatment Plan Experimental Treatment 2 Interventions

This is the main arm of the study in which all 25 anticipated participants will be enrolled into.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Brigham and Women's Hospital Boston, MA

Dana Farber Cancer Institute Boston, MA

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1128

Patients Recruited

382,000+

Abbott Nutrition

Industry Sponsor

Trials

173

Patients Recruited

33,700+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial. [2018] Physical exercises offer a variety of health benefits to cancer survivors during and post-treatment. However, exercise-based pre-habilitation is not well reported in major uro-oncology surgery. The aim of this study was to investigate the feasibility, the adherence, and the efficacy of a short-term physical pre-habilitation program to patients with invasive bladder cancer awaiting radical cystectomy (RC).

2. United States pubmed.ncbi.nlm.nih.gov

The Potential of Prehabilitation in Radical Cystectomy Pathways: Where Are We Now? [2021] The growing recognition of prehabilitation has caused an emerging paradigm shift in surgical cancer care and an integrated component of the cancer care continuum. This narrative review aims to update and inform the urological community of the potential of prehabilitation before radical cystectomy.

3. United States pubmed.ncbi.nlm.nih.gov

The Feasibility and Impact of a Presurgical Exercise Intervention Program (Prehabilitation) for Patients Undergoing Cystectomy for Bladder Cancer. [2022] To assess the feasibility of a prehabilitation program for cystectomy patients and to determine the effectiveness of the program in improving strength and functional capacity in the peri-operative period.

4. Germany pubmed.ncbi.nlm.nih.gov

Role of prehabilitation following major uro-oncologic surgery: a narrative review. [2022] Functional status and physical independence play a key role in terms of quality of life, access to treatment, and continuity of care. Surgery, a central component of cancer treatments, leads to detrimental effects on functional capacity, which can be peculiarly relevant in vulnerable patients undergoing major procedures. Prehabilitation is a multidisciplinary intervention that uses the preoperative period to prevent or attenuate treatment-related functional decline and its subsequent consequences. This paper narratively reviews the rationale and the evidence of prehabilitation for uro-oncologic surgery.

5. United States pubmed.ncbi.nlm.nih.gov

Implementing a Multimodal Prehabilitation Program to Radical Cystectomy in a Comprehensive Cancer Center: A Pilot Study to Assess Feasibility and Outcomes. [2022] Radical cystectomy(RC) often leads to postoperative morbidity and complications. We conducted a pilot study on the effectiveness of multimodal prehabilitation, a preoperative conditioning method shown to be effective for colorectal surgery, in bladder cancer patients soon to undergo RC. We assessed patients' adherence to the prehabilitation regimen and changes in their physical condition.

6. England pubmed.ncbi.nlm.nih.gov

EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial. [2023] Radical cystectomy (RC) is the standard treatment for patients with non-metastatic muscle-invasive bladder cancer, as well as for patients with therapy refractory high-risk non-muscle invasive bladder cancer. However, 50-65% of patients undergoing RC experience perioperative complications. The risk, severity and impact of these complications is associated with a patient's preoperative cardiorespiratory fitness, nutritional and smoking status and presence of anxiety and depression. There is emerging evidence supporting multimodal prehabilitation as a strategy to reduce the risk of complications and improve functional recovery after major cancer surgery. However, for bladder cancer the evidence is still limited. The aim of this study is to investigate the superiority of a multimodal prehabilitation programme versus standard-of-care in terms of reducing perioperative complications in patients with bladder cancer undergoing RC.

7. United States pubmed.ncbi.nlm.nih.gov

Prehabilitation for major abdominal urologic oncology surgery. [2019] Whether prehabilitation in radical cystectomy adds to the effort of reducing postoperative morbidity and impairments in the survivorship phase has until recently received limited attention. This narrative review aims to summarize the current evidence base on prehabilitaion interventions focusing on the efficacy of procedure-specific interventions and the influence on postoperative outcomes.

8. United States pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive prehabilitation program for patients undergoing radical cystectomy. [2023] Coordinated preoperative optimization programs for radical cystectomy (RC) are limited and non-comprehensive. We evaluated the feasibility and acceptability of a coordinated, multi-faceted prehabilitation program for RC patients at a high-volume bladder cancer referral center.

9. United States pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. [2022] Prehabilitation programs aim to optimise patients in order to enhance post-operative recovery. This study aims to review the composition of prehabilitation programs for patients undergoing major abdominal cancer surgery and define the outcome measures that are used to evaluate this intervention.