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

NCT ID: NCT04496219

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2022-08-23

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm I (acupuncture, BCG)

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.

Group Type: EXPERIMENTAL

Acupuncture Therapy

Intervention Type: DEVICE

Undergo acupuncture therapy

BCG Solution

Intervention Type: BIOLOGICAL

Given by intravesical injection

Best Practice

Intervention Type: OTHER

Receive standard of care symptom management

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Arm II (BCG, standard of care)

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.

Group Type: ACTIVE_COMPARATOR

Acupuncture Therapy

Intervention Type: DEVICE

Undergo acupuncture therapy

BCG Solution

Intervention Type: BIOLOGICAL

Given by intravesical injection

Best Practice

Intervention Type: OTHER

Receive standard of care symptom management

Quality-of-Life Assessment

Intervention Type: OTHER

Ancillary studies

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Acupuncture Therapy

Undergo acupuncture therapy

Intervention Type: DEVICE

BCG Solution

Given by intravesical injection

Intervention Type: BIOLOGICAL

Best Practice

Receive standard of care symptom management

Intervention Type: OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

Acupuncture; Bacillus Calmette Guerin Solution; Bacillus Calmette-Guerin Solution; TICE BCG Solution; standard of care; standard therapy; Quality of Life Assessment

Eligibility Criteria

Inclusion Criteria

• English-speaking
• Diagnosis of American Urological Association (AUA) high-risk non-muscle invasive bladder cancer (NMIBC), including high grade (HG) pT1 (invading only the lamina propria of the bladder), recurrent HG pTa (superficial tumors), HG pTa > 3 cm in size or multifocal, any carcinoma in situ, any variant histology, any lymphovascular invasion, and HG prostatic urethral involvement
• Diagnosis with urothelial carcinoma (primary histologic subtype), localized to the bladder, in the absence of nodal or other visceral metastases
• Patients who have been indicated for induction intravesical BCG in shared-decision-making with their primary urologist
• Have not received acupuncture in the previous 3 months
• Access to phone for study contacts
• Willing and able to participate in trial activities
• Platelets: 20,000/ uL or greater
• Absolute neutrophil count (ANC): 500 cells/uL or greater
• Able to understand and willing to sign written informed consent in English

Exclusion Criteria

• Subjects who have had intravesical or systemic chemotherapy or radiation therapy for bladder cancer or for other malignancies prior to entering the study
• Subjects who are indicated to receive other intravesical agents or therapies concurrently with BCG will be excluded
• Subjects who have muscle-invasive bladder cancer, radiographic evidence of lymph node metastases or metastatic disease involving other organs including brain metastases
• Patients with predominant histology other than urothelial carcinoma of the bladder who would not otherwise be considered candidates for BCG
• BCG is contraindicated in:

• Patients who are pregnant or lactating
• Patients with active tuberculosis
• Immunosuppressed patients with congenital or acquired immune deficiency, whether due to concurrent disease (e.g. acquired immunodeficiency syndrome [AIDS], lymphoma, leukemia), concomitant cancer therapy (cytotoxic drugs, radiation), or immunosuppressive therapy (e.g. corticosteroids, disease-modifying anti-rheumatic drugs [DMARDs])
• Symptomatic urinary tract infection
• Febrile illness
• Patients requiring chronic treatment with certain antibiotics that may interfere with the effectiveness of BCG
• Any previous allergies or severe reactions to BCG
• Not pregnant or trying to become pregnant. Acupuncture points included in the protocol are contraindicated with pregnancy
• Does not have a pacemaker. There is potential of electrostimulation interfering with the operation and function of pacemakers
• Patients requiring chronic treatment with certain antibiotics that may interfere with the effectiveness of BCG. Fluoroquinolone therapy may decrease the efficacy of intravesical BCG. Antibiotic therapy for ongoing treatment of active tuberculosis will decrease the efficacy of intravesical BCG
• Uncontrolled or concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded. Acupuncture points included in the protocol are contraindicated with pregnancy and BCG is contraindicated in pregnancy
• Pacemaker. Patients with pacemakers are restricted due to the potential of electrostimulation interfering with a pacemakers operation
• Platelets: < 20,000/ uL. Risk of bleeding with acupuncture
• ANC: < 500 cells/uL. Risk of infection with acupuncture
• Received acupuncture in the previous 3 months. Acupuncture treatment effects persist after a course of treatment, previous exposure to the intervention has the potential to affect the baseline data for treatment and control arms

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Sarah Psutka

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah P. Psutka

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2020-05021

Identifier Type: REGISTRY

Identifier Source: secondary_id

10544

Identifier Type: OTHER

Identifier Source: secondary_id

RG1007421

Identifier Type: -

Identifier Source: org_study_id