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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
45
Undergo acupuncture therapy
Given by intravesical injection
Receive standard of care symptom management
Ancillary studies
Ancillary studies
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled
Will be described via qualitative report.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)
Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.
Time frame: Baseline, up to 1 week after completion of treatment, an average of 7 weeks
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Will be described via qualitative report. Protocol adherence is defined as completion of the acupuncture interventions and follow-up surveys if randomized to the acupuncture arm or completion of the follow-up surveys if randomized to the control arm.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Patient Satisfaction
Patients' responses to the Cancer Care Satisfaction survey at 3 weeks and at the conclusion of induction Bacillus Calmette-Guerin (BCG) between two arms will be compared using t-test.
Time frame: At 3 weeks and after completion of treatment, an average of 7 weeks
Clinic Staff's Responses to Surveys
Clinic staff's responses to surveys assessing the healthcare burden of this protocol and time spent undergoing the acupuncture therapy for the experimental arm will be described via qualitative report
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Number of Adverse Events
BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
BCG Instillation Adherence (Out of a Possible Planned Six Treatments)
BCG instillation adherence (successful adherence defined as the number of successfully administered BCG instillations of a possible 6 total) and weeks missed (measured as total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG). Results between the acupuncture and control arms will be compared via t-test.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
Bladder and Bowel Symptoms as Self Reported by Patients
Assessed using the EORTC - Non-Muscle Invasive Bladder Cancer 24 (EORTC-NMIBC24) symptom index, which was specifically designed to assess bladder and bowel symptoms for patients with NMIBC including assessments of impact of intravesical therapy. All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Time frame: From week 1 to week 6 of treatment
Quality of Life: EORTC-QLQ-C30
Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30). All of the subscales and single-item measures range in score from 0 to 100 and a high scale score represents a higher response level (ranging from 0 = low to 100 = high/healthy level of function; from 0 = low to 100 = high quality-of-life; from 0 = low to 100 = high level of symptomatology/problems). Subscale and global health status scores are each calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100.
Time frame: From week 1 to week 6 of treatment
Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types
Will be compared via Wilcoxon rank sum test.
Time frame: Up to 1 week after completion of treatment, an average of 7 weeks
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