Trial Outcomes & Findings for Trial to Study Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy (NCT NCT07455409)
NCT ID: NCT07455409
Last Updated: 2026-05-01
Results Overview
Feasibility will be defined as ≥15 patients with CIPN completing ≥8 EA treatments of a 10-treatment EA program
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
5 Months
Results posted on
2026-05-01
Participant Flow
During the study period, 31 patients with early-stage breast cancer consented onto the trial. Among these, 23 met the eligibility criteria, and 20 of the 23 were enrolled and started treatment. The first patient was consented on 8/29/2019 and the last patient was consented on 4/25/2023.
Participant milestones
| Measure |
Electro-Acupuncture (EA)
EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes.
Electro-acupuncture: Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
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|---|---|
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Overall Study
STARTED
|
20
|
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Overall Study
COMPLETED
|
18
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Overall Study
NOT COMPLETED
|
2
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Reasons for withdrawal
| Measure |
Electro-Acupuncture (EA)
EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes.
Electro-acupuncture: Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
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|---|---|
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Overall Study
transportation challenges
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1
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Overall Study
difficulty attending multiple appointments due to chronic knee pain
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1
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Baseline Characteristics
Trial to Study Electro-Acupuncture in Subjects With Chemotherapy-Induced Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Electro-Acupuncture (EA)
n=20 Participants
EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes.
Electro-acupuncture: Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=14 Participants
|
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Age, Categorical
Between 18 and 65 years
|
10 Participants
n=14 Participants
|
|
Age, Categorical
>=65 years
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10 Participants
n=14 Participants
|
|
Age, Continuous
|
66.5 years
n=14 Participants
|
|
Sex: Female, Male
Female
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20 Participants
n=14 Participants
|
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Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=14 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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18 Participants
n=14 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=14 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
|
Region of Enrollment
United States
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20 participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 5 MonthsPopulation: The number of patients that completed 8 or more EA sessions. Two subjects discontinued treatments (10%), with one withdrawing after 3 EA sessions due to transportation challenges, and the other ceased participation after 6 sessions, citing difficulty attending multiple appointments due to chronic knee pain
Feasibility will be defined as ≥15 patients with CIPN completing ≥8 EA treatments of a 10-treatment EA program
Outcome measures
| Measure |
Electro-Acupuncture (EA)
n=20 Participants
EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes.
Electro-acupuncture: Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
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|---|---|
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Number of Participants That Complete ≥ 8 EA Treatments of a 10-treatment EA Program
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18 Participants
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SECONDARY outcome
Timeframe: Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)Population: Baseline BPI-SF questionnaires were completed by all 20 patients
The change in neuropathic pain after a 10-treatment EA program in subjects with CIPN, was assessed by the Brief Pain Inventory Short Form (BPI-SF) at Baseline, 2-Week Post EA, and 3 Month Post EA. Used to evaluate the severity of a subject's pain and the impact of this pain on the subject's daily functioning. Pain and interference are rated on a 10-point scale (0 = no pain/interference and 10 = pain as bad as you can imagine/complete interference). Higher scores mean worse outcomes.
Outcome measures
| Measure |
Electro-Acupuncture (EA)
n=20 Participants
EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes.
Electro-acupuncture: Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
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|---|---|
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Change in Neuropathic Pain After a 10-treatment EA Program
Mean BPI-SF Baseline Worst Pain Score in the Last Week
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5.86 Scores on a scale
Standard Deviation 2.92
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Change in Neuropathic Pain After a 10-treatment EA Program
Mean BPI-SF 2-week post EA Worst Pain Score in Last Week
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3.65 Scores on a scale
Standard Deviation 2.91
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Change in Neuropathic Pain After a 10-treatment EA Program
Mean BPI-SF 3-month Post EA Worst Pain Score in Last Week
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3.71 Scores on a scale
Standard Deviation 2.46
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SECONDARY outcome
Timeframe: Baseline, 2-weeks post-EA (9 weeks), and 3-months post-EA (5 months)Population: 20 patients completed the questionnaires
Assessed by the Total Outcome Index (TOI), including the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) subscale at Baseline, 2-Week Post EA, and 3 Month Post EA. The Total Outcome Index (TOI) ranges from 0 to 100, with higher scores consistently indicating better outcomes. Items are rated on a 0-4 Likert scale and negatively worded items are reverse scored so that higher values always reflect better health status. The neurotoxicity subscale score is calculated by summing the scored responses to the neurotoxicity items (with standard prorating if some items are missing), and the TOI is calculated by summing the Physical Well-Being, Functional Well-Being, and Neurotoxicity subscale scores. Lower scores on either measure indicate worse symptoms or functioning, while higher scores reflect improvement or better quality of life related to neurotoxicity.
Outcome measures
| Measure |
Electro-Acupuncture (EA)
n=20 Participants
EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes.
Electro-acupuncture: Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
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|---|---|
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Change in Quality of Life After a 10-treatment EA Program
Baseline Mean TOI Score
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56.95 Scores on a scale
Standard Deviation 16.74
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Change in Quality of Life After a 10-treatment EA Program
2-Week Post EA Mean TOI Score
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70.76 Scores on a scale
Standard Deviation 17.67
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Change in Quality of Life After a 10-treatment EA Program
3-Month Post EA Mean TOI Score
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73.85 Scores on a scale
Standard Deviation 12.9
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OTHER_PRE_SPECIFIED outcome
Timeframe: 5 MonthsPopulation: The localized skin biopsy site infections led to the discontinuation of skin biopsies for IENF density quantification
Measure the change in intraepidermal nerve fiber (IENF) density after a 10-treatment EA program in subjects with CIPN
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 5 MonthsPopulation: The change in serum inflammatory cytokines were measured from baseline to end of treatment. 7 Patients were analyzed for serum inflammatory cytokines.
Measure the changes in serum levels of inflammatory markers including erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), TNF-α, IL-1, and IL-6 after a 10-treatment EA program in subjects with CIPN.
Outcome measures
| Measure |
Electro-Acupuncture (EA)
n=7 Participants
EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes.
Electro-acupuncture: Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
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|---|---|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
CCL2 · Serum Levels Stayed the Same
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2 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
CCL2 · Serum Levels Increased
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0 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
CCL2 · Serum Level Change Unavailable
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0 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
CCL4 · Serum Levels Declined
|
2 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
CCL4 · Serum Levels Stayed the Same
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3 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
CCL4 · Serum Levels Increased
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2 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
CCL4 · Serum Level Change Unavailable
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0 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-17 · Serum Levels Declined
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1 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-17 · Serum Levels Stayed the Same
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4 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-17 · Serum Levels Increased
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2 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-17 · Serum Level Change Unavailable
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0 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-8 · Serum Levels Declined
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5 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-8 · Serum Levels Stayed the Same
|
1 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-8 · Serum Levels Increased
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0 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-8 · Serum Level Change Unavailable
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1 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-13 · Serum Levels Declined
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0 Participants
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|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-13 · Serum Levels Stayed the Same
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6 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-13 · Serum Levels Increased
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0 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-13 · Serum Level Change Unavailable
|
1 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-10 · Serum Levels Declined
|
1 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-10 · Serum Levels Stayed the Same
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0 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-10 · Serum Levels Increased
|
3 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-10 · Serum Level Change Unavailable
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3 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-12 · Serum Levels Declined
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0 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-12 · Serum Levels Stayed the Same
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4 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-12 · Serum Levels Increased
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1 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-12 · Serum Level Change Unavailable
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2 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-2 · Serum Levels Declined
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2 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-2 · Serum Levels Stayed the Same
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4 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-2 · Serum Levels Increased
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1 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-2 · Serum Level Change Unavailable
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0 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IFN-g · Serum Levels Declined
|
3 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IFN-g · Serum Levels Stayed the Same
|
0 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IFN-g · Serum Levels Increased
|
4 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IFN-g · Serum Level Change Unavailable
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0 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-7 · Serum Levels Declined
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3 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-7 · Serum Levels Stayed the Same
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4 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-7 · Serum Levels Increased
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0 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-7 · Serum Level Change Unavailable
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0 Participants
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
TNFa · Serum Level Change Unavailable
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0 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
CCL2 · Serum Levels Declined
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5 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-6 · Serum Levels Declined
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4 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-6 · Serum Levels Stayed the Same
|
3 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-6 · Serum Levels Increased
|
0 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
IL-6 · Serum Level Change Unavailable
|
0 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
TNFa · Serum Levels Declined
|
3 Participants
|
|
Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
TNFa · Serum Levels Stayed the Same
|
1 Participants
|
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Changes in Serum Levels of Inflammatory Markers After a 10-treatment EA Program
TNFa · Serum Levels Increased
|
3 Participants
|
Adverse Events
Electro-Acupuncture (EA)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Electro-Acupuncture (EA)
n=20 participants at risk
EA is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA will be administered for a total of 10 treatments over a 7-week period. EA will be done twice weekly for Weeks 1-3 and then weekly for Weeks 4-7. Each treatment will take approximately 30 minutes.
Electro-acupuncture: Electro-acupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation and involves passing a small electrical current between pairs of acupuncture needles.
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|---|---|
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Infections and infestations
Cellulitis
|
5.0%
1/20 • Number of events 1 • Approximately 11 weeks, from the time of informed consent to 7 days after study intervention ends.
Adverse events were collected at every treatment visit
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Infections and infestations
Skin Infection
|
25.0%
5/20 • Number of events 6 • Approximately 11 weeks, from the time of informed consent to 7 days after study intervention ends.
Adverse events were collected at every treatment visit
|
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General disorders
Fatigue
|
10.0%
2/20 • Number of events 2 • Approximately 11 weeks, from the time of informed consent to 7 days after study intervention ends.
Adverse events were collected at every treatment visit
|
Additional Information
Polly Niravath, M.D.
Houston Methodist Neal Cancer Center
Phone: (713) 441-9948
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place