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Phase 1/2 Randomized Clinical Trial of In-clinic acupuncture Prior to Bacillus Calmette-Guérin in Patients with High-risk Non-muscle-invasive Bladder Cancer.

European urology oncology
December 1, 2024
Sarah P Psutka et al. (11 authors)
Journal ArticleRandomized Controlled TrialClinical Trial, Phase IIClinical Trial, Phase IHuman StudyClinical
Study Details

Study Goal

The researchers aimed to evaluate the feasibility, safety, and tolerability of weekly preprocedural acupuncture in patients receiving induction BCG for high-risk non-muscle-invasive bladder cancer (NMIBC).

Results Summary

Acupuncture was found to be feasible and safe, with no related adverse events. Patients receiving acupuncture reported greater improvements in urinary symptoms and high satisfaction (96% found it "very/extremely helpful").

Population

Patients with high-risk NMIBC undergoing induction BCG (median age 70.3 yr, 76% male).

Effective Dosage

Weekly in-office acupuncture prior to each BCG instillation.

Duration

Duration of induction BCG treatment (specific weeks not stated, but follow-up was at week 7).

Interactions

None mentioned

Extracted Claims (9)
InterventionDirectionEndpointPopulationDosageImpactClaim #
acupuncture
decrease
pain and urinary urgency/frequency
other patient populations
-
reduced
#1
acupuncture
increase
median urinary symptoms
patients in the acupuncture arm
9.5, interquartile range [IQR] 0.0-19.0 vs 0.0, IQR -14.3 to 7.1
demonstrated greater improvements in
#2
acupuncture
decrease
patient-reported urinary symptoms
patients receiving acupuncture
-
was associated with
#3
acupuncture
no change
feasible and safe
patients receiving induction BCG
-
was
#4
acupuncture
increase
improved urinary function scores
patients undergoing acupuncture
-
observed
#5
acupuncture
increase
satisfaction with treatments
patients receiving acupuncture
-
reported high degrees of
#6
acupuncture
increase
very/extremely helpful
acupuncture patients
96%
was
#7
acupuncture
increase
acupuncture to other patients
acupuncture patients
91%
would recommend
#8
acupuncture
increase
high patient satisfaction
patients receiving acupuncture
-
was associated with
#9
Abstract

BACKGROUND: Treatment-related dose-limiting dysuria and irritative bladder symptoms are common in patients receiving intravesical bacillus Calmette-Guérin (BCG) to treat non-muscle-invasive bladder cancer (NMIBC). Acupuncture has been shown to reduce pain and urinary urgency/frequency in other patient populations. OBJECTIVE: To evaluate the feasibility, safety, and tolerability of weekly in-clinic preprocedural acupuncture among patients receiving induction BCG. DESIGN, SETTING, AND PARTICIPANTS: Patients with high-risk NMIBC undergoing induction BCG were randomized 2:1 to a standardized acupuncture protocol (acupuncture) versus the standard-of-care control arm. INTERVENTION: In-office acupuncture prior to each BCG instillation. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: Feasibility was assessed via recruitment, retention, and intervention adherence. Acupuncture safety and tolerability were assessed via physician-reported Common Terminology Criteria for Adverse Events version 5.0 and adverse events (AEs). Secondary endpoints included BCG treatment adherence, patient-reported BCG-related toxicity, and bladder cancer-specific and generic (European Organisation for Research and Treatment of Cancer [EORTC]-QLQ-NMIBC-24 and EORTC-QLQ-NMIBC-C30) quality of life (QOL). Subjective assessments of acupuncture acceptability were performed through patient surveys. RESULTS AND LIMITATIONS: A total of 43 individuals were randomized 2:1 to the acupuncture (n = 28) versus control (n = 15) group. The median age was 70.3 yr, and 76% were male. Week 7 follow-up surveys were completed by 93%; six participants withdrew early due to disease progression, refractory gross hematuria, or preference. Acupuncture was delivered successfully prior to each BCG treatment, with no acupuncture-related AEs or interruptions to induction BCG. BCG-attributed AEs were reported by 91% acupuncture and 100% control individuals, including pain (28% vs 43%, p = 0.34) and urinary symptoms (62% vs 79%, p = 0.31). Comparing acupuncture patients with controls, change in QOL over the study period demonstrated greater improvements in median urinary symptoms (9.5, interquartile range [IQR] 0.0-19.0 vs 0.0, IQR -14.3 to 7.1; p = 0.02) among patients in the acupuncture arm. Of the acupuncture patients, 96% reported that acupuncture was "very/extremely helpful," and 91% would recommend acupuncture to other patients. Limitations include modest sample size and single-institution design. CONCLUSIONS: Acupuncture prior to induction BCG treatments is feasible and safe. In this phase 1/2 trial, improved urinary function scores were observed among patients undergoing acupuncture. Patients receiving acupuncture reported high degrees of satisfaction with treatments. PATIENT SUMMARY: We evaluated the safety and feasibility of delivering acupuncture in a urology clinic prior to weekly intravesical bladder cancer treatments with bacillus Calmette-Guérin (BCG) in a randomized controlled trial. We found that acupuncture could be delivered safely prior to weekly BCG instillations and that the use of acupuncture was associated with high patient satisfaction and a decrease in patient-reported urinary symptoms compared with usual care.

Medical Subject Headings (MeSH)
HumansUrinary Bladder NeoplasmsMaleBCG VaccineFemaleAgedAcupuncture TherapyMiddle AgedAdministration, IntravesicalAdjuvants, ImmunologicNeoplasm InvasivenessFeasibility StudiesQuality of LifeNon-Muscle Invasive Bladder Neoplasms
Study Links
Quality Scores
Safety90
Efficacy80/10
Quality75/10
Research Impact Scores
APT Score0.05
Weight Score2.34
Normalized Score0.83
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