NCT04496219

Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer

Acupuncture vs. Standard of Care for Induction Intravesical BCG-Related Adverse Events in High-Risk Non-Muscle Invasive Bladder Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the safety and feasibility of utilizing acupuncture in patients with high-risk bladder cancer that has not spread to the surrounding muscle (non-muscle invasive) undergoing treatment with Intravesical BCG. BCG is a weakened form of the bacterium Mycobacterium bovis that does not cause disease. It is used in a solution to stimulate the immune system in the treatment of bladder cancer. Unfortunately, many patients experience side effects such as pelvic pain, painful urination, severe urgency, frequency, urge incontinence, need to urinate at night, and/or infectious complications. These side effects may cause patients to delay or stop BCG treatment. Acupuncture is a medical intervention in which fine metallic needles are inserted into anatomical locations of the body to stimulate the peripheral and the central nervous system. Giving acupuncture before each intravesical BCG treatment may help to reduce the side effects of intravesical BCG, and help patients complete treatment. Specific outcomes of interest include acceptability to patients, effect of acupuncture on intravesical BCG-related side effects, and adverse events associated with acupuncture.

Detailed description

OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo acupuncture therapy and receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. ARM II: Patients receive BCG via intravesical injection on days 1, 8, 15, 22, 29, and 36 in the absence of unacceptable toxicity. Patients also receive standard of care symptom management. Patients may undergo acupuncture therapy after completion of intravesical BCG therapy. After completion of study, patients are followed up at 1 week.

Conditions

• Bladder Urothelial Carcinoma In Situ
• Recurrent Bladder Urothelial Carcinoma
• Stage 0a Bladder Cancer AJCC v8
• Stage 0is Bladder Cancer AJCC v8
• Stage I Bladder Cancer AJCC v8
• Superficial Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
DEVICE	Acupuncture Therapy	Undergo acupuncture therapy
BIOLOGICAL	BCG Solution	Given by intravesical injection
OTHER	Best Practice	Receive standard of care symptom management
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2021-01-22
• Primary completion: 2022-08-16
• Completion: 2022-08-23
• First posted: 2020-08-03
• Last updated: 2024-01-02
• Results posted: 2024-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study