Trial Outcomes & Findings for Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer (NCT NCT03505671)
NCT ID: NCT03505671
Last Updated: 2022-06-01
Results Overview
Will estimate means and standard deviations by group for the EORTC QLQ-CIPN20 sensory subscale, the correlation between the two measures, and the within-person change. To estimate effect size, we will use an analysis of covariance (ANCOVA) model at week 12, which will include the group and the baseline value. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded) \[13\]. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Baseline up to week 12
Results posted on
2022-06-01
Participant Flow
Participant milestones
| Measure |
Group 1 (Acupuncture)
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Group 1 (Acupuncture)
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer
Baseline characteristics by cohort
| Measure |
Group 1 (Acupuncture)
n=11 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 12.5 • n=7 Participants
|
56.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
23 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
Will estimate means and standard deviations by group for the EORTC QLQ-CIPN20 sensory subscale, the correlation between the two measures, and the within-person change. To estimate effect size, we will use an analysis of covariance (ANCOVA) model at week 12, which will include the group and the baseline value. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded) \[13\]. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=10 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20)
Baseline
|
16.7 score on a scale
Standard Deviation 3.7
|
17.5 score on a scale
Standard Deviation 3.0
|
|
Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20)
Week 12
|
13.7 score on a scale
Standard Deviation 2.7
|
14.8 score on a scale
Standard Deviation 5.2
|
|
Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20)
Week 12 - Baseline (Change)
|
-2.9 score on a scale
Standard Deviation 4.2
|
-2.5 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Baseline up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Using a 4-point Likert scale (1 = "not at all," 2 = "a little," 3 = "quite a bit," and 4 = "very much"), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=10 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
Baseline EORTC Subscale
|
11.1 score on a scale
Standard Deviation 3.2
|
11.3 score on a scale
Standard Deviation 2.1
|
|
Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
Week 12 EORTC Subscale
|
11.0 score on a scale
Standard Deviation 1.8
|
11.1 score on a scale
Standard Deviation 3.3
|
|
Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
Week 12 - Baseline (Change) EORTC Subscale
|
0.1 score on a scale
Standard Deviation 2.2
|
-0.1 score on a scale
Standard Deviation 2.7
|
|
Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
Baseline EORTC Autonomic Subscale
|
2.7 score on a scale
Standard Deviation 0.9
|
2.8 score on a scale
Standard Deviation 0.8
|
|
Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
Week 12 - EORTC Autonomic Subscale
|
2.4 score on a scale
Standard Deviation 0.7
|
2.3 score on a scale
Standard Deviation 0.5
|
|
Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
Week 12 - Baseline EORTC Autonomic Subscale
|
-0.3 score on a scale
Standard Deviation 1.1
|
-0.5 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=10 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Severity (None 1)
|
4 Participants
|
2 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Severity (Mild 2)
|
3 Participants
|
8 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Severity (Moderate 3)
|
2 Participants
|
1 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Severity (Severe 4)
|
1 Participants
|
1 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Severity (Very severe 5)
|
0 Participants
|
0 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Severity (None 1)
|
1 Participants
|
2 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Severity (Mild 2)
|
6 Participants
|
4 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Severity (Moderate 3)
|
2 Participants
|
3 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Severity (Severe 4)
|
0 Participants
|
0 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Severity (Very severe 5)
|
0 Participants
|
0 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Interference - Not at all (1)
|
4 Participants
|
1 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Interference - A little bit (2)
|
2 Participants
|
7 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Interference - Somewhat (3)
|
2 Participants
|
2 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Interference -Quite a bit (4)
|
2 Participants
|
2 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline - Numbness or Tingling Interference - Very much (5)
|
0 Participants
|
0 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Interference - Not at all (1)
|
3 Participants
|
7 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Interference - A little bit (2)
|
5 Participants
|
1 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Interference - Somewhat (3)
|
1 Participants
|
3 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Interference - Quite a bit (4)
|
0 Participants
|
0 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Numbness or Tingling Interference - Very much (5)
|
0 Participants
|
0 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Baseline (Change) Numbness or Tingling Severity (Decreased, less than or equal to -1)
|
5 Participants
|
7 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Baseline (Change) Numbness or Tingling Severity - Same (0)
|
3 Participants
|
1 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Baseline (Change) Numbness or Tingling Severity (Increased, >/= 1)
|
1 Participants
|
3 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Baseline (Change) Numbness or Tingling Interference - (Decreased, </= -1)
|
3 Participants
|
7 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Baseline (Change) Numbness or Tingling Interference - (Same - 0)
|
5 Participants
|
3 Participants
|
|
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Week 12 - Baseline (Change) Numbness or Tingling Interference - (Increased, >/= -1)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=11 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Baseline - Grade 1 Numbness or Tingling
|
10 Participants
|
10 Participants
|
|
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Baseline - Grade 2 Numbness or Tingling
|
1 Participants
|
2 Participants
|
|
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Baseline - Grade 3 Numbness or Tingling
|
0 Participants
|
0 Participants
|
|
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Week 12 - Grade 1 Numbness or Tingling
|
7 Participants
|
9 Participants
|
|
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Week 12 Grade 2 Numbness or Tingling
|
1 Participants
|
1 Participants
|
|
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Week 12 Grade 3 Numbness or Tingling
|
0 Participants
|
1 Participants
|
|
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Week 12 - Baseline Numbness or Tingling Severity Decreased (</= 1)
|
0 Participants
|
0 Participants
|
|
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Week 12 - Baseline Numbness or Tingling Severity Same (0)
|
7 Participants
|
9 Participants
|
|
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Week 12 - Baseline Numbness or Tingling Severity Increased (>/= 1)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=9 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=10 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy
Chemotherapy dose standard
|
6 Participants
|
7 Participants
|
|
Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy
Chemotherapy dose decreased due to chemotherapy induced peripheral neuropathy
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=9 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=11 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Number of Cycles of Completed Chemotherapy
|
4.4 cycles
Standard Deviation 0.7
|
4.2 cycles
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. Treatment ended early for 2 participants in the intervention group, discontinued the intervention
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=9 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)
Baseline - Cross sectional area - sural
|
3.1 meters squared
Standard Deviation 1.5
|
2.8 meters squared
Standard Deviation 0.7
|
|
Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)
Baseline - Cross sectional area - median
|
14.2 meters squared
Standard Deviation 6.3
|
12.7 meters squared
Standard Deviation 3.3
|
|
Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)
Week 12 - Cross sectional area - sural
|
3.0 meters squared
Standard Deviation 1.3
|
3.0 meters squared
Standard Deviation 1.2
|
|
Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)
Week 12 - Cross sectional area - median
|
14.6 meters squared
Standard Deviation 7.5
|
11.9 meters squared
Standard Deviation 2.8
|
|
Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)
Week 12 - Baseline - Cross sectional area - sural (Change)
|
-0.4 meters squared
Standard Deviation 1.0
|
0.1 meters squared
Standard Deviation 1.3
|
|
Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)
Week 12 - Baseline - Cross sectional area - median (Change)
|
0.1 meters squared
Standard Deviation 1.5
|
-1.0 meters squared
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: Up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Nerve conduction studies measure impairment of electrical function in large peripheral nerves and measures amplitude and latency of neuronal signaling. Ranging from 0.1 μm to 20 μm. Reduction in the amplitude indicates axonal damage.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=9 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Baseline - Amplitude (sural)
|
9.5 micrometers
Standard Deviation 5.0
|
9.5 micrometers
Standard Deviation 7.6
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Amplitude (sural)
|
8.8 micrometers
Standard Deviation 3.6
|
10.9 micrometers
Standard Deviation 7.8
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Baseline Amplitude (sural)
|
-1.5 micrometers
Standard Deviation 4.6
|
0.7 micrometers
Standard Deviation 1.8
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Baseline - Amplitude - Tibial, ankle
|
13.3 micrometers
Standard Deviation 5.6
|
11.0 micrometers
Standard Deviation 3.8
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Amplitude - Tibial, ankle
|
12.4 micrometers
Standard Deviation 5.2
|
11.5 micrometers
Standard Deviation 3.5
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Baseline - Amplitude - Tibial, ankle (Change)
|
-1.5 micrometers
Standard Deviation 1.9
|
-0.2 micrometers
Standard Deviation 1.7
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Baseline - Amplitude - Tibial, pop fossa
|
8.5 micrometers
Standard Deviation 5.2
|
7.8 micrometers
Standard Deviation 3.7
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Amplitude - Tibial, pop fossa
|
10.0 micrometers
Standard Deviation 4.4
|
7.9 micrometers
Standard Deviation 3.0
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Baseline - Amplitude - Tibial, pop fossa (Change)
|
1.0 micrometers
Standard Deviation 3.4
|
-0.8 micrometers
Standard Deviation 1.9
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Baseline - Amplitude - median, wrist
|
9.6 micrometers
Standard Deviation 3.6
|
10.3 micrometers
Standard Deviation 2.8
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Amplitude - median, wrist
|
10.1 micrometers
Standard Deviation 4.4
|
11.2 micrometers
Standard Deviation 2.7
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Baseline - Amplitude - median, wrist (Change)
|
0.1 micrometers
Standard Deviation 3.3
|
0.4 micrometers
Standard Deviation 2.4
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Baseline - Amplitude - median, elbow
|
9.3 micrometers
Standard Deviation 3.7
|
10.0 micrometers
Standard Deviation 2.8
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Amplitude - median, elbow
|
9.3 micrometers
Standard Deviation 4.0
|
10.8 micrometers
Standard Deviation 2.7
|
|
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Week 12 - Baseline Amplitude - median, elbow (Change)
|
-0.3 micrometers
Standard Deviation 3.1
|
0.5 micrometers
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=9 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Baseline - Latency Sural
|
3.4 milliseconds
Standard Deviation 0.6
|
3.4 milliseconds
Standard Deviation 0.6
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Latency Sural
|
3.4 milliseconds
Standard Deviation 0.6
|
3.3 milliseconds
Standard Deviation 0.6
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 -Baseline - Latency Sural (Change)
|
0.0 milliseconds
Standard Deviation 0.7
|
0.0 milliseconds
Standard Deviation 0.3
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Baseline - Latency tibial, ankle
|
3.6 milliseconds
Standard Deviation 0.3
|
4.0 milliseconds
Standard Deviation 0.5
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Latency tibial, ankle
|
3.6 milliseconds
Standard Deviation 0.5
|
3.8 milliseconds
Standard Deviation 0.6
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Baseline Latency tibial, ankle (Change)
|
-0.1 milliseconds
Standard Deviation 0.8
|
-0.2 milliseconds
Standard Deviation 0.4
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Baseline - Latency tibial, pop
|
11.5 milliseconds
Standard Deviation 1.0
|
11.7 milliseconds
Standard Deviation 1.2
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Latency tibial, pop
|
11.2 milliseconds
Standard Deviation 1.1
|
11.5 milliseconds
Standard Deviation 1.2
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Baseline Latency tibial, pop
|
-0.2 milliseconds
Standard Deviation 0.6
|
0.1 milliseconds
Standard Deviation 0.4
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Baseline - Latency median wrist
|
4.0 milliseconds
Standard Deviation 1.1
|
3.7 milliseconds
Standard Deviation 0.5
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Latency median wrist
|
4.4 milliseconds
Standard Deviation 1.9
|
3.7 milliseconds
Standard Deviation 0.5
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Baseline Latency median wrist (Change
|
0.5 milliseconds
Standard Deviation 1.0
|
-0.1 milliseconds
Standard Deviation 0.4
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Baseline - Latency median elbow
|
7.8 milliseconds
Standard Deviation 1.5
|
7.5 milliseconds
Standard Deviation 0.7
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Latency median elbow
|
8.2 milliseconds
Standard Deviation 2.5
|
7.5 milliseconds
Standard Deviation 0.7
|
|
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Baseline - Latency median elbow (Change)
|
0.4 milliseconds
Standard Deviation 1.2
|
0.0 milliseconds
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. Two participants in the intervention group discontinued the intervention/treatment earlier than the anticipated 12 weeks time frame.
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=9 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Baseline - Velocity Sural
|
51.1 meters per second
Standard Deviation 3.0
|
45.9 meters per second
Standard Deviation 3.8
|
|
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Velocity Sural
|
50.5 meters per second
Standard Deviation 5.6
|
48.7 meters per second
Standard Deviation 4.2
|
|
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Baseline Velocity Sural (Change)
|
-1.0 meters per second
Standard Deviation 6.6
|
2.2 meters per second
Standard Deviation 3.6
|
|
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Baseline - Velocity Tibial
|
49.1 meters per second
Standard Deviation 3.3
|
50.3 meters per second
Standard Deviation 5.1
|
|
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Velocity Tibial
|
51.1 meters per second
Standard Deviation 5.6
|
49.4 meters per second
Standard Deviation 5.4
|
|
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Baseline - Velocity Tibial (Change)
|
2.1 meters per second
Standard Deviation 4.3
|
-2.0 meters per second
Standard Deviation 2.3
|
|
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Baseline - Velocity Median
|
55.5 meters per second
Standard Deviation 3.7
|
54.2 meters per second
Standard Deviation 4.1
|
|
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
12 Weeks - Velocity Median
|
55.3 meters per second
Standard Deviation 5.9
|
55.5 meters per second
Standard Deviation 2.8
|
|
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Week 12 - Baseline - Velocity Median (Change)
|
-0.6 meters per second
Standard Deviation 5.3
|
0.1 meters per second
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Up to week 12Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Outcome measures
| Measure |
Group 1 (Acupuncture)
n=4 Participants
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=7 Participants
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Nerve Fiber Density in the Skin
Baseline - Nerve fiber density, distal leg
|
7.8 fibers per millimeter
Standard Deviation 3.2
|
8.3 fibers per millimeter
Standard Deviation 3.3
|
|
Nerve Fiber Density in the Skin
Week 12 - Nerve fiber density, distal leg
|
3.5 fibers per millimeter
Standard Deviation 0.7
|
4.3 fibers per millimeter
Standard Deviation 1.7
|
|
Nerve Fiber Density in the Skin
Week 12 - Baseline - Nerve fiber density, distal leg
|
-5.1 fibers per millimeter
Standard Deviation 2.8
|
-4.5 fibers per millimeter
Standard Deviation 3.0
|
Adverse Events
Group 1 (Acupuncture)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (Usual Care)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1 (Acupuncture)
n=11 participants at risk
Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
Group 2 (Usual Care)
n=12 participants at risk
Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bruising
|
0.00%
0/11 • 12 weeks
|
8.3%
1/12 • Number of events 1 • 12 weeks
|
Additional Information
Nancy Avis, PhD
Wake Forest Baptist Comprehensive Cancer Center
Phone: 336-713-5440
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place