Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Carcinoma in Situ

Non-Muscle Invasive Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Pharmaceutical Solutions

All Drugs and Chemicals

BCG Vaccine

Vaccines

Adjuvants, Immunologic

Immunologic Factors

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.

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.

Acupuncture Therapy

BCG Solution

Receive standard of care symptom management

Best Practice

Quality-of-Life Assessment

Questionnaire Administration

Sarah P. Psutka

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.

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

Acupuncture vs. Standard of Care for Induction Intravesical BCG-Related Adverse Events in High-Risk Non-Muscle Invasive Bladder Cancer

Will be described via qualitative report.

Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.

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.

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.

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

BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care.

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.

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.

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.

Will be compared via Wilcoxon rank sum test.

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Associate Professor

Toxicity or AEs related to BCG administration were collected by patient survey on a weekly basis using the CTCAE v.50 assessment of Systemic Therapy Toxicity. Patients in the acupuncture arm were surveyed weekly prior to acupuncture treatments regarding side effects and potential adverse events associated with the acupuncture intervention using the CTCAE v5. There were two acupuncture-related adverse events: 1 patient reporting a Grade 1 bruise and 1 patient reporting a Grade 1 pain.

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.

Acupuncture Therapy: Undergo acupuncture therapy

BCG Solution: Given by intravesical injection

Best Practice: Receive standard of care symptom management

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm I (Acupuncture, BCG)

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.

Acupuncture Therapy: Undergo acupuncture therapy

BCG Solution: Given by intravesical injection

Best Practice: Receive standard of care symptom management

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm II (BCG, Standard of Care)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Smoking Status

Pathologic stage Ta: Presence of a papillary tumor that does not infiltrate the bladder wall. Tis: The existence of carcinoma in situ, which constitutes a non-invasive flat high-grade (G3) cancer. T1: Tumor penetration into the connective tissue beneath the surface lining. All other stages were excluded. Ta is the least aggressive, and Tis and T1 are the most aggressive. Please note these were not outcomes, but were inclusion criteria for patients who would be eligible to receive induction BCG and therefore would be candidates for study entry.

Tumor stage

"The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was."

Charlson Comorbidity Index

Eastern Cooperative Oncology Group (ECOG) performance status criteria is used to assess how a patient's disease is progressing and to assess how the disease affects the daily living abilities of the patient. The scores on this instrument range from 0-5 (0=fully active and 5=dead), with higher scores indicating poorer performance.

Eastern Cooperative Oncology Group (ECOG) performance status

Some patients signed the consent but couldn't start the treatment because of progression of disease, those data were not collected.

Dr. Sarah Psutka, MD, MS

Total number screened for trial eligibility

Screened for Trial Eligibility

Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled

Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)

Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)

Patient Satisfaction

Clinic Staff's Responses to Surveys

Bowel Symptoms

Fatigue

Flu-like Symptoms

Headache

Hematuria

Other

Pain

Urinary Symptoms

The number of AEs are not mutually exclusive and participants may have reported more than one AE

Number of Adverse Events

This p value relates to instillation adherence

Instillation adherence

Missed visits

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

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Constipation Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Diarrhea Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Urinary Symptoms.

Constipation Symptoms

Diarrhea Symptoms

Bladder and Bowel Symptoms as Self Reported by Patients

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Global Health.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Physical Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Emotional Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Social Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Fatigue Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Pain Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Malaise Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Role Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Cognitive Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Nausea Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Dyspnoea Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Insomnia Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Appetite Loss Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Finances.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intravesical Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Worries.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Bloating Symptoms.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Sexual Function.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Male Sex Problems.

For the patient survey, the two arms will be compared using chi-squared. This analysis is for Intimacy.

Spots Global Cancer Trial Database for superficial bladder urothelial carcinoma