Phase 2 N=45 Randomized Supportive Care

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

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

Bottom Line

View on ClinicalTrials.gov: NCT04496219 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled — 45; 0; 3; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Acupuncture Therapy (Device); BCG Solution (Biological); Best Practice (Other); Quality-of-Life Assessment (Other); Questionnaire Administration (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fred Hutchinson Cancer Center
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled	45; 0; 3; 2	—
PRIMARY Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)	25; 14; 2; 2; 0; 1	—
PRIMARY Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)	17; 8; 4; 0; 4; 5	—
PRIMARY Patient Satisfaction	—	—
PRIMARY Clinic Staff's Responses to Surveys	—	—
PRIMARY Number of Adverse Events	14; 5; 36; 15; 16; 3	—
SECONDARY BCG Instillation Adherence (Out of a Possible Planned Six Treatments)	6; 6; 0; 0	0.97
SECONDARY Bladder and Bowel Symptoms as Self Reported by Patients	0; 0; 0; 0; -9.52; 0	0.5638
SECONDARY Quality of Life: EORTC-QLQ-C30	-8.33; -4.17; 0; 0; 2.78; -4.17	0.8092
SECONDARY Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types	—	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04496219). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.