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

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}

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.

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
• 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).

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.

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

Findings from Research

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]

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 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]

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]

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 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 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]

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]

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]

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

The Potential of Prehabilitation in Radical Cystectomy Pathways: Where Are We Now? [2021]

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]

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

Role of prehabilitation following major uro-oncologic surgery: a narrative review. [2022]

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]

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]

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

Prehabilitation for major abdominal urologic oncology surgery. [2019]

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

Implementation of a comprehensive prehabilitation program for patients undergoing radical cystectomy. [2023]

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

A systematic review of prehabilitation programs in abdominal cancer surgery. [2022]