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

Phase 2

Waitlist Available

Led By Sarah P. Psutka

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 weeks and after completion of treatment, an average of 7 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial studies if acupuncture can help reduce side effects in patients with high-risk bladder cancer receiving BCG treatment. Acupuncture involves inserting thin needles into specific body points to relieve pain. The goal is to see if it helps patients complete their cancer treatment by reducing discomfort.

Eligible Conditions

Bladder Cancer
Urothelial Carcinoma Bladder

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 weeks and after completion of treatment, an average of 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 weeks and after completion of treatment, an average of 7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 weeks and after completion of treatment, an average of 7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinic Staff's Responses to Surveys

Number of Adverse Events

Patient Satisfaction

+3 more

Secondary study objectives

BCG Instillation Adherence (Out of a Possible Planned Six Treatments)

Bladder and Bowel Symptoms as Self Reported by Patients

Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types

+1 more

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT04496219

62%

Urinary Symptoms

58%

Fatigue

38%

Headache

35%

Bowel Symptoms

35%

Flu-like Symptoms

35%

Hematuria

31%

Other

27%

Pain

Bruise

100%

80%

60%

40%

20%

Study treatment Arm

Arm I (Acupuncture, BCG)

Arm II (BCG, Standard of Care)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (acupuncture, BCG)Experimental Treatment5 Interventions

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.

Group II: Arm II (BCG, standard of care)Active Control5 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acupuncture Therapy

2018

Completed Phase 2

~260

BCG Solution

2017

Completed Phase 2

~60