Trial Outcomes & Findings for Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer (NCT NCT04496219)
NCT ID: NCT04496219
Last Updated: 2024-01-02
Results Overview
Will be described via qualitative report.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Up to 1 week after completion of treatment, an average of 7 weeks
Results posted on
2024-01-02
Participant Flow
Participant milestones
| Measure |
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.
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)
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
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
17
|
|
Overall Study
COMPLETED
|
25
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acupuncture for the Treatment of Intravesical BCG-Related Adverse Events in High-Risk Non-muscle Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Acupuncture, BCG)
n=28 Participants
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 II (BCG, Standard of Care)
n=15 Participants
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
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Continuous
|
72.6 years
n=5 Participants
|
64.7 years
n=7 Participants
|
70.27 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Smoking Status
Never
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Smoking Status
Former
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Smoking Status
Current
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Smoking Status
Unknown
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Tumor stage
pTis
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Tumor stage
pTa
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Tumor stage
pT1
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Tumor stage
Unknown
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Charlson Comorbidity Index
0
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Charlson Comorbidity Index
1
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Charlson Comorbidity Index
2 or greater
|
16 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
2
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 week after completion of treatment, an average of 7 weeksWill be described via qualitative report.
Outcome measures
| Measure |
Screened for Trial Eligibility
n=50 Participants
Total number screened for trial eligibility
|
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.
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
|
|---|---|---|
|
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled
Eligible and agreed to participate
|
45 Participants
|
—
|
|
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled
Did not meet inclusion criteria
|
0 Participants
|
—
|
|
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled
Declined to participate
|
3 Participants
|
—
|
|
Trial Recruitment: Number of Participants Eligible, Enrolled, and Not Enrolled
Regulatory hold 12/17/21-1/13/22
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Baseline, up to 1 week after completion of treatment, an average of 7 weeksWill be described via qualitative report. Successful retention is defined as continued participation within the trial until 1 week following completion of induction.
Outcome measures
| Measure |
Screened for Trial Eligibility
n=28 Participants
Total number screened for trial eligibility
|
Arm II (BCG, Standard of Care)
n=17 Participants
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
|
|---|---|---|
|
Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)
Number of enrolled and retained participants
|
25 Participants
|
14 Participants
|
|
Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)
Lost to follow-up: disease progression
|
2 Participants
|
2 Participants
|
|
Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)
Lost to follow-up: patient decision
|
0 Participants
|
1 Participants
|
|
Trial Retention (Proportion Retained Versus All Enrolled, Reason for Not Completing)
Lost to follow-up: refractory hematuria
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 1 week after completion of treatment, an average of 7 weeksWill 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.
Outcome measures
| Measure |
Screened for Trial Eligibility
n=28 Participants
Total number screened for trial eligibility
|
Arm II (BCG, Standard of Care)
n=17 Participants
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
|
|---|---|---|
|
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Logistics/Scheduling Issues
|
4 Participants
|
5 Participants
|
|
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Protocol adherence
|
17 Participants
|
8 Participants
|
|
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Missed visits due to UTI
|
4 Participants
|
0 Participants
|
|
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Withdrew due to disease progression
|
3 Participants
|
2 Participants
|
|
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Withdrew due to patient preference
|
0 Participants
|
1 Participants
|
|
Protocol Adherence (Proportion Adhered Versus All Enrolled, Specifics for How Protocol Was Not Followed and Why)
Delay due to treatment of other comorbid condition
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At 3 weeks and after completion of treatment, an average of 7 weeksPopulation: Data were not collected
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 1 week after completion of treatment, an average of 7 weeksPopulation: Data were not collected
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
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 1 week after completion of treatment, an average of 7 weeksPopulation: The number of AEs are not mutually exclusive and participants may have reported more than one AE
BCG related adverse events compared between patients receiving acupuncture and patients receiving standard of care.
Outcome measures
| Measure |
Screened for Trial Eligibility
n=146 Adverse Events
Total number screened for trial eligibility
|
Arm II (BCG, Standard of Care)
n=73 Adverse Events
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
|
|---|---|---|
|
Number of Adverse Events
Bowel Symptoms
|
14 Adverse Events
|
5 Adverse Events
|
|
Number of Adverse Events
Fatigue
|
36 Adverse Events
|
15 Adverse Events
|
|
Number of Adverse Events
Flu-like Symptoms
|
16 Adverse Events
|
3 Adverse Events
|
|
Number of Adverse Events
Headache
|
13 Adverse Events
|
0 Adverse Events
|
|
Number of Adverse Events
Hematuria
|
13 Adverse Events
|
11 Adverse Events
|
|
Number of Adverse Events
Other
|
8 Adverse Events
|
4 Adverse Events
|
|
Number of Adverse Events
Pain
|
9 Adverse Events
|
11 Adverse Events
|
|
Number of Adverse Events
Urinary Symptoms
|
37 Adverse Events
|
24 Adverse Events
|
SECONDARY outcome
Timeframe: Up to 1 week after completion of treatment, an average of 7 weeksBCG 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.
Outcome measures
| Measure |
Screened for Trial Eligibility
n=28 Participants
Total number screened for trial eligibility
|
Arm II (BCG, Standard of Care)
n=15 Participants
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
|
|---|---|---|
|
BCG Instillation Adherence (Out of a Possible Planned Six Treatments)
Instillation adherence
|
6 Visits
Interval 6.0 to 7.0
|
6 Visits
Interval 6.0 to 7.0
|
|
BCG Instillation Adherence (Out of a Possible Planned Six Treatments)
Missed visits
|
0 Visits
Interval 0.0 to 0.0
|
0 Visits
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: From week 1 to week 6 of treatmentAssessed 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.
Outcome measures
| Measure |
Screened for Trial Eligibility
n=25 Participants
Total number screened for trial eligibility
|
Arm II (BCG, Standard of Care)
n=14 Participants
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
|
|---|---|---|
|
Bladder and Bowel Symptoms as Self Reported by Patients
Constipation Symptoms
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Bladder and Bowel Symptoms as Self Reported by Patients
Diarrhea Symptoms
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -16.67 to 0.0
|
|
Bladder and Bowel Symptoms as Self Reported by Patients
Urinary Symptoms
|
-9.52 score on a scale
Interval -21.43 to 0.0
|
0 score on a scale
Interval -8.33 to 9.52
|
SECONDARY outcome
Timeframe: From week 1 to week 6 of treatmentAssessed 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.
Outcome measures
| Measure |
Screened for Trial Eligibility
n=25 Participants
Total number screened for trial eligibility
|
Arm II (BCG, Standard of Care)
n=14 Participants
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
|
|---|---|---|
|
Quality of Life: EORTC-QLQ-C30
Global Health Organization
|
-8.33 score on a scale
Interval -16.67 to 0.0
|
-4.17 score on a scale
Interval -16.67 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Physical Function
|
0 score on a scale
Interval -10.0 to 0.0
|
0 score on a scale
Interval -6.67 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Emotional Function
|
2.78 score on a scale
Interval 0.0 to 16.67
|
-4.17 score on a scale
Interval -12.5 to 12.5
|
|
Quality of Life: EORTC-QLQ-C30
Social Function
|
0 score on a scale
Interval -16.67 to 0.0
|
0 score on a scale
Interval -16.67 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Fatigue Symptoms
|
0 score on a scale
Interval -11.11 to 0.0
|
0 score on a scale
Interval 0.0 to 11.11
|
|
Quality of Life: EORTC-QLQ-C30
Pain Symptoms
|
0 score on a scale
Interval -16.67 to 0.0
|
0 score on a scale
Interval -16.67 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Malaise Symptoms
|
0 score on a scale
Interval -16.67 to 0.0
|
0 score on a scale
Interval 0.0 to 8.33
|
|
Quality of Life: EORTC-QLQ-C30
Role Function
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval -16.67 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Cognitive Function
|
0 score on a scale
Interval -16.67 to 0.0
|
0 score on a scale
Interval -16.67 to 8.33
|
|
Quality of Life: EORTC-QLQ-C30
Nausea Symptoms
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Dyspnoea Symptoms
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Insomnia Symptoms
|
0 score on a scale
Interval -33.33 to 33.33
|
0 score on a scale
Interval -16.67 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Appetite Loss Symptoms
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Finances
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Intravesical Symptoms
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Worries
|
-11.11 score on a scale
Interval -20.83 to 0.0
|
-8.33 score on a scale
Interval -16.67 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Bloating Symptoms
|
0 score on a scale
Interval -16.67 to 0.0
|
-8.33 score on a scale
Interval -16.67 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Sexual Function
|
0 score on a scale
Interval -16.67 to 0.0
|
0 score on a scale
Interval 0.0 to 16.67
|
|
Quality of Life: EORTC-QLQ-C30
Male Sex Problems
|
0 score on a scale
Interval -16.67 to 0.0
|
0 score on a scale
Interval -16.67 to 0.0
|
|
Quality of Life: EORTC-QLQ-C30
Intimacy
|
0 score on a scale
Interval -33.33 to 0.0
|
0 score on a scale
Interval -33.33 to 0.0
|
SECONDARY outcome
Timeframe: Up to 1 week after completion of treatment, an average of 7 weeksPopulation: Data were not collected
Will be compared via Wilcoxon rank sum test.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Acupuncture, BCG)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Arm II (BCG, Standard of Care)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Acupuncture, BCG)
n=26 participants at risk
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 II (BCG, Standard of Care)
n=14 participants at risk
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
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bruise
|
3.8%
1/26 • Number of events 1 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
0.00%
0/14 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
|
Gastrointestinal disorders
Bowel Symptoms
|
34.6%
9/26 • Number of events 14 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
21.4%
3/14 • Number of events 5 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
|
General disorders
Fatigue
|
57.7%
15/26 • Number of events 36 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
42.9%
6/14 • Number of events 15 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
|
General disorders
Flu-like Symptoms
|
34.6%
9/26 • Number of events 16 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
21.4%
3/14 • Number of events 3 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
|
Nervous system disorders
Headache
|
38.5%
10/26 • Number of events 13 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
0.00%
0/14 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
|
Renal and urinary disorders
Hematuria
|
34.6%
9/26 • Number of events 13 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
42.9%
6/14 • Number of events 11 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
|
Musculoskeletal and connective tissue disorders
Pain
|
26.9%
7/26 • Number of events 10 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
42.9%
6/14 • Number of events 11 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
|
Renal and urinary disorders
Urinary Symptoms
|
61.5%
16/26 • Number of events 37 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
78.6%
11/14 • Number of events 24 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
|
General disorders
Other
|
30.8%
8/26 • Number of events 8 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
|
21.4%
3/14 • Number of events 4 • Adverse events were recorded from the time of first exposure to acupuncture through the end of treatment, an average of 7 weeks, on a weekly basis. BCG related adverse events were compared between patients receiving acupuncture and patients receiving standard of care and were recorded up to 1 week after completion of treatment, an average of 7 weeks.
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.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place