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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2022
  • participants needed
    45
  • sponsor
    Fred Hutchinson Cancer Research Center
Updated on 18 February 2021

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.

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.

Details
Condition Recurrent Bladder Urothelial Carcinoma, Stage I Bladder Cancer AJCC v8, Bladder Urothelial Carcinoma In Situ, Stage 0a Bladder Cancer AJCC v8, Stage 0is Bladder Cancer AJCC v8, Superficial Bladder Urothelial Carcinoma
Treatment questionnaire administration, quality-of-life assessment, acupuncture therapy, Best Practice, BCG Solution
Clinical Study IdentifierNCT04496219
SponsorFred Hutchinson Cancer Research Center
Last Modified on18 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Stage 0is Bladder Cancer AJCC v8 or Recurrent Bladder Urothelial Carcinoma or Stage 0a Bladder Cancer AJCC v8 or Bladder Urothelial Carcinoma In Situ ...?
Do you have any of these conditions: Stage I Bladder Cancer AJCC v8 or Recurrent Bladder Urothelial Carcinoma or Stage 0a Bladder Cancer AJCC v8 or Bladder Urothelial Carcinoma In Situ or...?
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
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