Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer
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
MeSH terms: Carcinoma; Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Carcinoma in Situ; Non-Muscle Invasive Bladder Neoplasms
Intervention: Acupuncture Therapy; BCG Solution; Best Practice; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Undergo acupuncture therapy; Given by intravesical injection; Receive standard of care symptom management; Ancillary studies; Ancillary studies
Intervention MeSH terms: Pharmaceutical Solutions; BCG Vaccine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Urinary Bladder

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.
    

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