Physical Therapy for Bladder Cancer

Overseen By Sasha Knowlton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: No bladder cancer or cystectomy

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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if meeting with a physical therapist before bladder removal surgery can reduce complications and improve recovery for bladder cancer patients. Participants will receive a customized exercise plan to follow before surgery. The goal is to assess whether this approach aids recovery time, reduces hospital stays, and lowers the chance of readmission. Candidates for this trial include those diagnosed with bladder cancer and scheduled for bladder removal surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this physical therapy consultation is safe for bladder cancer patients?

Research has shown that exercise programs before surgery can be safe for bladder cancer patients. These programs can help reduce complications and improve the quality of life for those undergoing bladder surgery. Studies have demonstrated that exercise before surgery is safe and manageable for patients.

In one study, patients participated in a 4-week exercise program before their surgery. The program did not cause major issues, suggesting it is safe. Another review found that prehabilitation, or exercise before surgery, benefited bladder cancer patients, with most studies showing positive outcomes.

Overall, current research supports that physical therapy and exercise are safe for bladder cancer patients preparing for surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for bladder cancer, which often involve surgery, chemotherapy, or immunotherapy, this new approach focuses on a physical therapy regimen tailored to each patient. Researchers are excited because this method is designed to enhance patients' physical condition before surgery, potentially improving recovery times and outcomes. By offering a personalized exercise program, it addresses the individual needs of patients, which is a unique angle not typically explored in traditional bladder cancer treatments.

What evidence suggests that this physical therapy is effective for bladder cancer?

Research shows that exercise programs can greatly benefit bladder cancer patients undergoing surgery. In this trial, participants will receive a personalized exercise program after a Physical Therapy assessment, prior to their surgery. Studies have found that exercise can reduce the risk of complications and enhance both physical and emotional health. Specifically, 71% of the studies reviewed found that exercising before surgery benefited bladder cancer patients. This pre-surgery exercise, known as prehabilitation, helps patients feel more involved in their care and improves their overall well-being. Overall, exercising before surgery appears to lead to better outcomes for bladder cancer patients. ^{1 3 4 5 6}

Who Is on the Research Team?

Sasha E Knowlton, MD

Principal Investigator

Lineberger Comprehensive Cancer Center, The University of North Carolina Chapel Hill

Are You a Good Fit for This Trial?

This trial is for adults over 18 years old who have been diagnosed with bladder cancer and are scheduled to undergo a radical cystectomy. It's not open to those without a history of bladder cancer or who haven't had the surgery.

Inclusion Criteria

I have had bladder cancer in the past.

I was 18 or older when diagnosed with bladder cancer.

I have undergone or will undergo a surgery to remove my bladder.

Exclusion Criteria

I have never had bladder cancer or a major bladder surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-cystectomy Physical Therapy

Participants receive a physical therapy consultation and a personally tailored exercise program before surgery

Up to the date of cystectomy

1 visit (in-person)

Post-cystectomy Follow-up

Participants are monitored for post-operative complications, morbidity, and readmission rates

Up to 90 days after the date of cystectomy

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy

Trial Overview The study tests if seeing a physical therapist before surgery, and getting a custom exercise program can reduce complications after bladder removal surgery. The study looks back at past cases and also follows current patients.

How Is the Trial Designed?

Group I: A personally tailored exercise Experimental Treatment 1 Intervention

A personally tailored exercise program will be offered to the participants after the Physical Therapy assessment, before the surgery.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Published Research Related to This Trial

Radical cystectomy is the standard treatment for nonmetastatic, muscle invasive bladder cancer, but it has the highest mortality rate among uro-oncologic procedures, particularly affecting the growing number of elderly patients with comorbidities.

Prehabilitation before cystectomy aims to improve patients' physical condition through conditioning, strength training, and nutritional education, but current studies show mixed results regarding its effectiveness in reducing complications or mortality, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prehabilitation prior to radical cystectomy]. Giese, M., Butea-Bocu, M., Huber, J., et al.[2023]

A new home-based exercise intervention specifically designed for bladder cancer survivors is being piloted in a randomized controlled trial involving 30 participants, aiming to improve their physical and mental health outcomes from the point of diagnosis.

Participants will be monitored over 14 weeks, with data collected on their health and activity levels using accelerometers, to assess the effectiveness of the exercise program compared to usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The CADENCE pilot trial - Promoting physical activity in bladder cancer survivors: A protocol paper. Smith, L., Carrie, A., Tully, M., et al.[2022]

A review of 14 studies found no evidence that prehabilitation or rehabilitation interventions significantly improve overall health-related quality of life or reduce postoperative complications after radical cystectomy (RC).

However, preoperative and postoperative education in stoma care significantly improved patients' self-efficacy, and intensive smoking and alcohol cessation interventions showed notable effects on quit rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of pre and rehabilitation in radical cystectomy on health related quality of life and physical function: A systematic review. Jensen, BT., Thomsen, T., Mohamed, N., et al.[2022]

In a study of 78 bladder cancer patients treated with combined pre- and postoperative radiation therapy, the overall 5-year survival rate was 67%, with higher survival rates of 84% for lower-grade tumors (P1 and P2).

However, the treatment was associated with a significant increase in bowel obstructions, occurring in 37% of patients who received postoperative radiation compared to only 8% in those who did not, indicating a concerning level of toxicity despite the survival benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined pre- and postoperative adjuvant radiation therapy for bladder cancer--a ten year experience. Reisinger, SA., Mohiuddin, M., Mulholland, SG.[2019]

In a survey of 525 bladder cancer survivors, only 22.3% met public health exercise guidelines, highlighting a significant gap in physical activity among this group.

Those who met exercise guidelines reported significantly better quality of life scores across various domains, including functional well-being and sexual functioning, compared to those who were completely sedentary, suggesting that exercise may improve QoL for bladder cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between exercise and quality of life in bladder cancer survivors: a population-based study. Karvinen, KH., Courneya, KS., North, S., et al.[2015]

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]

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]

This scoping review analyzed 14 studies and identified a significant gap in understanding how physical activity (PA) interventions can impact bladder cancer (BC) treatment outcomes and quality of life, indicating a need for more focused research in this area.

While there is general recognition of the potential benefits of PA for BC patients, the review found no clear conclusions on the structure or processes of effective PA interventions, highlighting the necessity for further studies to develop exercise guidelines tailored for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for physical activity interventions in the treatment pathway of bladder cancer? A scoping review of the literature. Bessa, A., Bosco, C., Mehrotra, S., et al.[2022]

In a study of 39 patients with muscle invasive bladder cancer, neo-adjuvant combined chemo-radiotherapy showed a high response rate, with 67% of patients in remission after treatment, indicating its efficacy as a pre-operative intervention.

The treatment was well-tolerated, and 15 patients remained alive without evidence of tumor after a median follow-up of 87 months, demonstrating that even inoperable patients can benefit from this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined chemoradiotherapy for invasive bladder cancer: a feasibility approach in a non selected population. de Pree, C., Aapro, MS., Mermillod, B., et al.[2006]

A presurgical exercise program for bladder cancer patients is feasible and safe, with an 80% completion rate and no exercise-related adverse events reported during the study.

Participants showed significant improvements in physical function, including leg press strength and walking distance, as well as enhancements in quality of life, suggesting that exercise may help mitigate the negative impacts of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Feasibility of Presurgical Exercise in Bladder Cancer Patients Scheduled for Open Radical Cystectomy. Taaffe, DR., McCombie, SP., Galvão, DA., et al.[2023]

Citations

1. 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 ...

2. urotoday.com urotoday.com/conference-highlights/suo-2024/suo-2024-bladder-cancer/156665-suo-2024-a-personalized-and-pragmatic-approach-to-p-rehabilitation-for-patients-with-bladder-cancer.html

SUO 2024: A Personalized and Pragmatic Approach to (P) ... Prehabilitation offers significant potential benefits for patients, including improving engagement, candidacy for treatment, overall well-being, ...

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/cncr.35608

Prehabilitative/rehabilitative exercise, nutrition, and ... In this scoping review of randomized controlled trials investigating (p)rehabilitative support for patients with bladder cancer, 17 of 24 (71%) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04223063

Exercise-based Pre-habilitation in Bladder Cancer Patients ... The purpose of this study is to explore the feasibility and efficacy of a 12-week, home-based exercise program in bladder cancer patients undergoing curative ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1040842824000933

What is the role of physical exercise in the era of cancer ... Overall, the introduction of exercise in the prehabilitation context appears effective in improving outcomes, especially in some malignancies. Given the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5726122/

Rehabilitation interventions to improve patient-reported ... Survivors of muscle invasive bladder cancer (MIBC) experience physical and psychosocial side effects of cancer diagnosis and treatment.