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

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