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Effects of acupuncture to decrease adverse events in patients with high-risk non-muscle invasive bladder cancer
Sarah P Psutka1, Susan Veleber2,3, Jonathan Siman2,3
1Department of Urology, University of Washington School of Medicine, United States.
Contemporary Clinical Trials Communications
|December 23, 2022
Summary
This pilot study explored acupuncture's feasibility for reducing side effects in high-risk nonmuscle-invasive bladder cancer (NMIBC) patients undergoing Bacillus Calmette-Guerin (BCG) therapy. Results will guide larger trials on this complementary treatment.
Area of Science:
- Oncology
- Integrative Medicine
- Urology
Background:
- Intravesical Bacillus Calmette-Guerin (BCG) is standard for high-risk nonmuscle-invasive bladder cancer (NMIBC).
- Treatment-related serious adverse events (SAEs) and interruptions are common with BCG therapy.
- Acupuncture is being investigated as a complementary therapy to mitigate these adverse events.
Purpose of the Study:
- To evaluate the feasibility and efficacy of pre-procedure acupuncture in a urology clinic setting.
- To assess the impact of acupuncture on reducing SAEs and treatment interruptions in NMIBC patients receiving BCG.
- To inform the design of a larger, multi-center trial.
Main Methods:
- A randomized, attention/waitlist-controlled feasibility pilot study.
- 45 patients with high-risk NMIBC randomized 2:1 (acupuncture: control).
- Treatment group received acupuncture pre-BCG weekly for six weeks; control group received attention/waitlist control.
Main Results:
- Feasibility assessed via recruitment, retention, and protocol adherence.
- Efficacy measured by quality of life (EORTC-QLQ-NMIBC-24, EORTC-QLQ-C30), adverse events (CTCAE v5.0), and healthcare utilization.
- Acupuncture-specific adverse events and impact on clinic workflow were evaluated.
Conclusions:
- This study protocol provides a framework for investigating acupuncture's role in managing BCG therapy side effects.
- Findings will guide future large-scale trials to confirm acupuncture's benefits in NMIBC patients.
- The integration of acupuncture into urology clinics may offer a viable supportive care option.
