Prehabilitation for Bladder Cancer Surgery

(Prehab Trial)

Recruiting at 1 trial location

Overseen By Nnamdi Onochie

Age: 18+

Sex: Any

Trial Phase: Academic

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 All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help patients physically and nutritionally prepare for bladder removal surgery. It focuses on improving recovery and outcomes for those undergoing cystectomy, a procedure to remove the bladder, sometimes with a new bladder created from intestinal tissue. People planning to have this surgery and who understand the study details might be a good fit. The goal is to determine if preparing the body in these ways can lead to better surgical results. As an unphased trial, this study offers an opportunity to contribute to research that could enhance surgical recovery for future patients.

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 prior data suggests that this prehabilitation program is safe for bladder cancer surgery?

Research has shown that preparing for bladder cancer surgery with patient-focused prehabilitation is generally safe. Studies have found that exercise programs, included in this preparation, can improve quality of life by reducing complications and enhancing both physical and emotional health.

While specific data on negative effects is limited, the focus on improving patient wellness suggests it is well-tolerated. This approach aims to prepare the body physically and nutritionally, typically aiding recovery rather than causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about patient-centered surgical prehabilitation for bladder cancer surgery because it focuses on preparing patients physically and mentally before their operation. Unlike traditional approaches that emphasize post-surgery recovery, this method aims to enhance patients' overall strength, endurance, and well-being before they even enter the operating room. By potentially improving surgical outcomes and speeding up recovery times, it represents a proactive shift that could make a big difference for patients undergoing bladder cancer surgery.

What evidence suggests that this trial's prehabilitation program could be effective for bladder cancer surgery?

Research has shown that personalized programs for surgical preparation can lead to better outcomes. Studies have found that these programs lower the risk of complications and reduce hospital stays after surgery. They also enhance physical fitness, muscle strength, and breathing. For cancer patients, this preparation improves overall health and recovery. This method emphasizes physical and nutritional readiness before surgery, aiding quicker recovery. In this trial, participants will follow a standard treatment plan that includes patient-centered surgical prehabilitation, exercise training, and nutritional intervention. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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

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.

I have had surgery to redirect urine flow using part of my intestine.

Exclusion Criteria

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

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

I have a history of heart failure.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Training
• Nutritional Intervention
• Patient-Centered Surgical Prehabilitation

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).

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Abbott Nutrition

Industry Sponsor

Trials

173

Recruited

33,700+

Robert B. Ford

Abbott Nutrition

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Melissa Brotz

Abbott Nutrition

Chief Marketing Officer

Bachelor's degree in Journalism from Northwestern University

Published Research Related to This Trial

Prehabilitation, which includes a multimodal approach involving physical activity, nutrition, and lifestyle changes, can enhance recovery and functional capacity in patients undergoing radical cystectomy, as indicated by improved postoperative outcomes.

There is a need for further research to validate the effectiveness of prehabilitation in reducing long-term disability risks in high-risk patients, emphasizing the importance of collaboration among healthcare providers in implementing these strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of Prehabilitation in Radical Cystectomy Pathways: Where Are We Now? Jensen, BT., Lauridsen, SV., Scheede-Bergdahl, C.[2021]

A single-center randomized controlled trial showed that home-based physical prehabilitation before radical cystectomy significantly improves early mobilization, daily living activities, and health-related quality of life, although it did not affect length of hospital stay or complications.

Preoperative nutritional support for malnourished patients can enhance outcomes if provided 7-10 days before surgery, while interventions for smoking or alcohol cessation and psychological well-being have not yet been adequately studied in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation for major abdominal urologic oncology surgery. Jensen, BT., Lauridsen, SV., Jensen, JB.[2019]

A 4-week prehabilitation program for cystectomy patients aged 60 and older was found to be feasible and safe, with 80.4% of participants successfully completing the program without any adverse events.

Participants showed significant improvements in strength, endurance, and quality of life, which were sustained 90 days after surgery, indicating the potential benefits of prehabilitation in enhancing recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility and Impact of a Presurgical Exercise Intervention Program (Prehabilitation) for Patients Undergoing Cystectomy for Bladder Cancer. Kaye, DR., Schafer, C., Thelen-Perry, S., et al.[2022]

Prehabilitation programs for patients undergoing major abdominal cancer surgery include a mix of exercise, nutritional, and psychological interventions, but their composition and delivery methods vary widely across studies, indicating a need for standardization.

In a review of 9 studies involving 549 patients, no significant differences in post-operative complications were found between prehabilitation and standard care, suggesting that while prehabilitation may optimize recovery, its impact on reducing complications needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of prehabilitation programs in abdominal cancer surgery. Hijazi, Y., Gondal, U., Aziz, O.[2022]

This study aims to determine if a multimodal prehabilitation program can reduce the risk of perioperative complications in 154 patients undergoing radical cystectomy for bladder cancer, compared to standard care.

The primary outcome will measure the occurrence of significant complications (grade ≥2) within 90 days post-surgery, with secondary outcomes assessing fitness, hospital stay length, quality of life, and other health markers.

NCBI (Pubmed)

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. Akdemir, E., Sweegers, MG., Vrieling, A., et al.[2023]

A comprehensive prehabilitation program for patients undergoing radical cystectomy was successfully implemented, with 82 patients enrolled, showing high adherence rates to nutritional screening and supplements (100% and 82%, respectively).

The program led to a reduction in resource length of stay (RLOS) and had a modest impact on postoperative complications, with 30-day and 30- to 90-day complication rates of 56% and 40%, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive prehabilitation program for patients undergoing radical cystectomy. Smelser, WW., Tallman, JE., Gupta, VK., et al.[2023]

Multimodal prehabilitation interventions, which include exercise, nutrition, and psychological support, show promise in preserving functional capacity after major uro-oncologic surgeries like radical cystectomy and radical prostatectomy, based on a review of eight randomized controlled trials.

While prehabilitation appears effective and safe for maintaining functional status, it does not significantly impact traditional surgical outcomes such as complication rates or length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of prehabilitation following major uro-oncologic surgery: a narrative review. Minnella, EM., Carli, F., Kassouf, W.[2022]

A pilot study involving 32 bladder cancer patients showed that a 2-week multimodal prehabilitation program improved physical capacity, as evidenced by a 9.2% increase in the six-minute walk test results from baseline to 6 weeks post-surgery.

Patients adhered to the nutritional component of the program at a higher rate (81%) compared to the exercise component (62%), indicating that while the program is feasible, enhancing adherence to physical exercises may be necessary for optimal outcomes.

NCBI (Pubmed)

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. Jensen, BT., Jensen, JB., Love-Retinger, N., et al.[2022]

A short-term exercise-based pre-habilitation program for patients with invasive bladder cancer awaiting radical cystectomy showed a high adherence rate of 66%, indicating that most patients were able to follow the recommended exercise regimen.

The intervention group experienced a significant improvement in muscle power of 18% at the time of surgery compared to the standard group, suggesting that pre-habilitation can enhance physical strength and potentially improve recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based pre-habilitation is feasible and effective in radical cystectomy pathways-secondary results from a randomized controlled trial. Jensen, BT., Laustsen, S., Jensen, JB., et al.[2018]

Citations

1.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S000296101730569X

Patient-centered surgical prehabilitation

The preoperative time period must focus on optimal patient-centered decision-making and optimization of patient wellness.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10008243/

EffectiveNess of a multimodal preHAbilitation program in ...

There is emerging evidence supporting multimodal prehabilitation as a strategy to reduce the risk of complications and improve functional ...

3.

bcan.org

bcan.org/clinicaltrials/patient-centered-surgical-prehabilitation/

Patient-Centered Surgical Prehabilitation

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 ...

4.

bmccancer.biomedcentral.com

bmccancer.biomedcentral.com/articles/10.1186/s12885-024-13023-w

Efficacy of Prehabilitation in cancer patients: an Rcts ...

The results of the studies reporting reduced postoperative hospital stay, improved endurance, muscle strength, respiratory function, quality of ...

5.

journalofsurgicalresearch.com

journalofsurgicalresearch.com/article/S0022-4804(24)00766-2/abstract

The Impact of Surgical Prehabilitation on Postoperative ...

This systematic review aims to assess the efficacy of prehabilitation on postoperative outcomes across surgical specialties, focusing on physical functionality ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28456341/

Patient-centered surgical prehabilitation

Patient-centered surgical prehabilitation. ... Department of Surgery, University of Michigan Health System, Ann Arbor, MI, USA.

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05715684

NCT05715684 | Patient-Centered Surgical Prehabilitation

In this research study, the investigators hope to learn whether or not this combination of prehabilitation interventions has an impact on the recoverability of ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12198061/

The role of preoperative and postoperative exercise in ...

Exercise programs significantly enhance QoL in bladder cancer patients undergoing cystectomy by reducing complications and improving physical and emotional ...