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

68 Participants Needed

Trial Summary

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 data supports the idea that Physical Therapy for Bladder Cancer is an effective treatment?

The available research shows that physical therapy, including exercise-based prehabilitation, is effective for bladder cancer patients. Studies indicate that these exercises can improve the quality of life and physical function for patients undergoing surgery for bladder cancer. For example, one study found that a prehabilitation program improved strength and functional capacity in patients before and after surgery. Another study highlighted that exercise is associated with better quality of life in bladder cancer survivors. These findings suggest that physical therapy can be a beneficial treatment option for bladder cancer patients. ^{1 2 3 4 5}

What safety data exists for physical therapy in bladder cancer treatment?

The available research indicates that physical therapy, including prehabilitation and exercise interventions, is feasible and potentially beneficial for bladder cancer patients, particularly those undergoing radical cystectomy. Studies have shown improvements in functional parameters and adherence to exercise programs, though the impact on reducing complications or mortality is not yet confirmed. Further research is needed to establish comprehensive safety data. ^{1 5 6 7 8}

Is physical therapy a promising treatment for bladder cancer?

Yes, physical therapy, also known as exercise-based pre-habilitation, is a promising treatment for bladder cancer. It helps improve the physical condition of patients before surgery, which can lead to better health outcomes. Exercise can boost both mental and physical health, making it beneficial for cancer survivors. ^{1 6 7 9 10}

What is the purpose of this trial?

This single-site, non-randomized, study evaluates the impact of a physical therapy consultation for patients with bladder cancer scheduled for radical cystectomy (RC). The purpose of this study is to investigate whether consultation with a physical therapist and the development of a personally tailored exercise program in the pre-cystectomy period for patients with bladder cancer will result in reduced post-operative complications, morbidity, length of inpatient stay, improve readmission 30-day and 90-day and improve 90-day mortality. This study will be partially retrospective (pre-implementation of a physical therapy consultation order) and partially prospective.

Research Team

Sasha E Knowlton, MD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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 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]

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 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]

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]

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]

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 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 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]

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

Associations between exercise and quality of life in bladder cancer survivors: a population-based study. [2015]

3. United States 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. [2022]

4. 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]

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

Efficacy and Feasibility of Presurgical Exercise in Bladder Cancer Patients Scheduled for Open Radical Cystectomy. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The CADENCE pilot trial - Promoting physical activity in bladder cancer survivors: A protocol paper. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Prehabilitation prior to radical cystectomy]. [2023]

8. England 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. [2022]

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

Combined pre- and postoperative adjuvant radiation therapy for bladder cancer--a ten year experience. [2019]

10. Greece pubmed.ncbi.nlm.nih.gov

Combined chemoradiotherapy for invasive bladder cancer: a feasibility approach in a non selected population. [2006]