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Acupuncture Therapy for 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
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 weeks and after completion of treatment, an average of 7 weeks
Awards & highlights
Study Summary
This trial is studying whether acupuncture may help reduce side effects from BCG treatment for bladder cancer.
Eligible Conditions
- Bladder Cancer
- Urothelial Carcinoma Bladder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinic Staff's Responses to Surveys
Number of Adverse Events
Patient Satisfaction
+3 moreSecondary outcome measures
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 moreSide effects data
From 2022 Phase 2 trial • 45 Patients • NCT0449621962%
Urinary Symptoms
58%
Fatigue
38%
Headache
35%
Flu-like Symptoms
35%
Bowel Symptoms
35%
Hematuria
31%
Other
27%
Pain
4%
Bruise
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Acupuncture, BCG)
Arm II (BCG, Standard of Care)
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
BCG Solution
2021
Completed Phase 2
~50
Acupuncture Therapy
2018
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,336 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
555 Previous Clinical Trials
1,334,681 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,601 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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