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

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ClinicalTrials.gov Identifier: NCT04496219
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : February 12, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
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 Superficial Bladder Urothelial Carcinoma Device: Acupuncture Therapy Biological: BCG Solution Other: Best Practice Other: Quality-of-Life Assessment Other: Questionnaire Administration Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acupuncture vs. Standard of Care for Induction Intravesical BCG-Related Adverse Events in High-Risk Non-Muscle Invasive Bladder Cancer
Actual Study Start Date : January 22, 2021
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm I (acupuncture, BCG)
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.
Device: Acupuncture Therapy
Undergo acupuncture therapy
Other Name: Acupuncture

Biological: BCG Solution
Given by intravesical injection
Other Names:
  • Bacillus Calmette Guerin Solution
  • Bacillus Calmette-Guerin Solution
  • TICE BCG Solution

Other: Best Practice
Receive standard of care symptom management
Other Names:
  • standard of care
  • standard therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Active Comparator: Arm II (BCG, standard of care)
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.
Device: Acupuncture Therapy
Undergo acupuncture therapy
Other Name: Acupuncture

Biological: BCG Solution
Given by intravesical injection
Other Names:
  • Bacillus Calmette Guerin Solution
  • Bacillus Calmette-Guerin Solution
  • TICE BCG Solution

Other: Best Practice
Receive standard of care symptom management
Other Names:
  • standard of care
  • standard therapy

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Trial recruitment (proportion enrolled versus eligible, reason for not enrolling) [ Time Frame: Up to 1 week after completion of treatment ]
    Will be described via qualitative report.

  2. Trial retention (proportion retained versus all enrolled, reason for not completing) [ Time Frame: Baseline, up to 1 week after completion of treatment ]
    Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.

  3. Protocol adherence (proportion adhered versus all enrolled, specifics for how protocol was not followed and why) [ Time Frame: Up to 1 week after completion of treatment ]
    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.

  4. Patient satisfaction [ Time Frame: At 3 weeks and after completion of treatment ]
    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.

  5. Clinic staff's responses to surveys [ Time Frame: Up to 1 week after completion of treatment ]
    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

  6. Incidence of adverse events [ Time Frame: Up to 1 week after completion of treatment ]
    Adverse events associated with acupuncture therapy in the experimental arm will be described via qualitative report.


Secondary Outcome Measures :
  1. BCG instillation adherence (out of a possible planned six treatments) [ Time Frame: Up to 1 week after completion of treatment ]
    BCG instillation adherence (out of a possible planned six treatments (successful adherence defined as the number of successfully administered BCG instillations (of a possible 6 total), treatment interruptions (defined as number of weeks that a BCG instillation was delayed), weeks missed (measured as any vs none, and total weeks that BCG was not administered of the planned 6 weekly induction doses of intravesical BCG), intravesical BCG dwell times (measured in minutes), and requirement for dose reductions (measured as yes/no) between the acupuncture and control arms will be compared via t-test and chi-square as appropriate.

  2. Bladder and bowel symptoms as self reported by patients [ Time Frame: From week 1 to week 6 of treatment ]
    Compare the responses of patients in the experimental and control arms to the European Organization for Research and Treatment of Cancer - 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.

  3. Quality of life: EORTC-QLQ-C30 [ Time Frame: From week 1 to week 6 of treatment ]
    Assessed using the EORTC Health and Quality of Life Rating Scale (EORTC-QLQ-C30).

  4. Median weekly pill counts of medications prescribed for the management of BCG-related side effects, standardized by dosage across medication types [ Time Frame: Up to 1 week after completion of treatment ]
    Will be compared via Wilcoxon rank sum test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04496219


Contacts
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Contact: Sarah P. Psutka 206.598.4294 spsutka@uw.edu

Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Sarah P. Psutka    206-598-4294    spsutka@uw.edu   
Principal Investigator: Sarah P. Psutka         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sarah P. Psutka Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT04496219    
Other Study ID Numbers: RG1007421
P30CA015704 ( U.S. NIH Grant/Contract )
NCI-2020-05021 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
10544 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Fred Hutchinson Cancer Research Center:
Urinary Bladder
Additional relevant MeSH terms:
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Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Pharmaceutical Solutions
BCG Vaccine
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs