Acupuncture vs. Standard of Care for Induction Intravesical BCG-Related Adverse Events in High-Risk Non-Muscle Invasive Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
时间窗: Up to 1 week after completion of treatment, an average of 7 weeks
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.
Patient Satisfaction
时间窗: At 3 weeks and after completion of treatment, an average of 7 weeks
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
时间窗: Up to 1 week after completion of treatment, an average of 7 weeks
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
Number of Adverse Events
时间窗: Up to 1 week after completion of treatment, an average of 7 weeks
BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care.
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled
时间窗: Up to 1 week after completion of treatment, an average of 7 weeks
Will be described via qualitative report.
Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)
时间窗: Baseline, up to 1 week after completion of treatment, an average of 7 weeks
Will be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.
次要结局
- BCG Instillation Adherence (Out of a Possible Planned Six Treatments)(Up to 1 week after completion of treatment, an average of 7 weeks)
- Bladder and Bowel Symptoms as Self Reported by Patients(From week 1 to week 6 of treatment)
- Quality of Life: EORTC-QLQ-C30(From week 1 to week 6 of treatment)
- Median Weekly Pill Counts of Medications Prescribed for the Management of BCG-related Side Effects, Standardized by Dosage Across Medication Types(Up to 1 week after completion of treatment, an average of 7 weeks)
研究者
Sarah Psutka
Associate Professor
Fred Hutchinson Cancer Center