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

NCT04496219 | Completed Phase 2 Results FDA Device

• 4 other identifiers: RG1007421P30CA015704NCI-2020-0502110544
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

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

Keywords

Urinary Bladder

Outcome Measures

Primary Outcomes (6)

• Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled

  Will be described via qualitative report.

  Up to 1 week after completion of treatment, an average of 7 weeks

• Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)

  Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.

  Baseline, up to 1 week after completion of treatment, an average of 7 weeks

• Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)

  Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm.

  Up to 1 week after completion of treatment, an average of 7 weeks

• Patient Satisfaction

  Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test.

  At 3 weeks and after completion of treatment, an average of 7 weeks

• Clinic Staff's Responses to Surveys

  Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report

  Up to 1 week after completion of treatment, an average of 7 weeks

• Number of Adverse Events

  BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care.

  Up to 1 week after completion of treatment, an average of 7 weeks

Secondary Outcomes (4)

• BCG Instillation Adherence (Out of a Possible Planned Six Treatments)

  Up to 1 week after completion of treatment, an average of 7 weeks

• Bladder and Bowel Symptoms as Self Reported by Patients

  From week 1 to week 6 of treatment

• Quality of Life: EORTC-QLQ-C30

  From week 1 to week 6 of treatment

• Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types

  Up to 1 week after completion of treatment, an average of 7 weeks

Study Arms (2)

Arm I (acupuncture, BCG)

EXPERIMENTAL

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.

Device: Acupuncture Therapy; Biological: BCG Solution; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (BCG, standard of care)

ACTIVE COMPARATOR

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.

Device: Acupuncture Therapy; Biological: BCG Solution; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Acupuncture Therapy DEVICE

Undergo acupuncture therapy

Also known as: Acupuncture

Arm I (acupuncture, BCG); Arm II (BCG, standard of care)

BCG Solution BIOLOGICAL

Given by intravesical injection

Also known as: Bacillus Calmette Guerin Solution, Bacillus Calmette-Guerin Solution, TICE BCG Solution

Arm I (acupuncture, BCG); Arm II (BCG, standard of care)

Best Practice OTHER

Receive standard of care symptom management

Also known as: standard of care, standard therapy

Arm I (acupuncture, BCG); Arm II (BCG, standard of care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (acupuncture, BCG); Arm II (BCG, standard of care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (acupuncture, BCG); Arm II (BCG, standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Acupuncture Therapy; Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Results Point of Contact

• Title: Dr. Sarah Psutka, MD, MS
• Organization: University of Washington

spsutka@uw.edu

206-598-4294

Study Officials

• Sarah P. Psutka

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 3, 2020
• Study Start: January 22, 2021
• Primary Completion: August 16, 2022
• Study Completion: August 23, 2022
• Last Updated: January 2, 2024
• Results First Posted: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)