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Brief Title: 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

INTRODUCTION

  • Org Study ID: RG1007421
  • Secondary ID: P30CA015704, NCI-2020-05021, 10544
  • NTC ID: NCT04496219
  • Sponsor: Fred Hutchinson Cancer Research Center

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.

  • Overall Status
    Recruiting
  • Start Date
    January 22, 2021
  • Phase
    Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Trial recruitment (proportion enrolled versus eligible, reason for not enrolling)

Primary Outcome 1 - Timeframe: Up to 1 week after completion of treatment

Primary Outcome 2 - Measure: Trial retention (proportion retained versus all enrolled, reason for not completing)

Primary Outcome 2 - Timeframe: Baseline, up to 1 week after completion of treatment

Primary Outcome 3 - Measure: Protocol adherence (proportion adhered versus all enrolled, specifics for how protocol was not followed and why)

Primary Outcome 3 - Timeframe: Up to 1 week after completion of treatment

Primary Outcome 4 - Measure: Patient satisfaction

Primary Outcome 4 - Timeframe: At 3 weeks and after completion of treatment

Primary Outcome 5 - Measure: Clinic staff's responses to surveys

Primary Outcome 5 - Timeframe: Up to 1 week after completion of treatment

Primary Outcome 6 - Measure: Incidence of adverse events

Primary Outcome 6 - Timeframe: Up to 1 week after completion of treatment

CONDITION

  • 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

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Sarah P. Psutka

Role: Principal Investigator

Affiliation: Fred Hutch/University of Washington Cancer Consortium

Overall Contact

Name: Sarah P. Psutka

Phone: 206.598.4294

Email: spsutka@uw.edu

LOCATION

Facility Status Contact
Facility: Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington 98109
United States
Status: Recruiting Contact: Contact
Sarah P. Psutka
206-598-4294
spsutka@uw.edu