Trial Outcomes & Findings for Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy (NCT NCT01163682)
NCT ID: NCT01163682
Last Updated: 2023-09-21
Results Overview
The change in neuropathic pain, as measured by the mean Brief Pain Inventory-Short Form (BPI-SF) worst pain score, from baseline to 16 weeks, in the study group that received electro-acupuncture (intervention), was compared to the change in neuropathic pain in the study group that received sham acupuncture (control). Scores range from 0 (no pain)-10 (worst pain) with a higher score indicating worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
63 participants
Primary outcome timeframe
Baseline, 16 weeks
Results posted on
2023-09-21
Participant Flow
180 participants were screened, of which 99 refused to take part in the study, 16 were ineligible, and 2 withdrew before the intervention began. 63 participants were enrolled and randomized to the two treatment groups.
Participant milestones
| Measure |
Electro-acupuncture
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
Electro-acupuncture: Subjects will be placed in prone position and acupuncture sites will be cleaned with alcohol preparation. Stainless steel disposable acupuncture needle (diameter 0.25mm) will be inserted into the skin to appropriate depth needed to elicit de qi(approximately 3-4mm). Selected acupuncture points will be attached to2 leads connected to an electro-stimulator that generates 2 Hz of mixed pulsatile intervals for a total of 30 minutes. The acupuncturist will return two times during the treatment at 10 and 20 minutes with needles in situ to check on the patients and needles. Needles not attached to the electro-stimulator will be manipulated manually to elicit de qi one time during the treatment.
|
Sham Acupuncture
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.
Sham acupuncture: Will be utilizing a sham control that consists of collapsible acupuncture needle so that there is no penetration of skin. The sham needles will be place on 4 non specific body points. The electro-stimulator will be attached to the needles for 30 minutes but will not be turned on. The acupuncturist will return two times during the treatment at 10 and 20 minutes to check on the patient. The acupuncturist will touch the collapsible acupuncture needs to simulate the manipulation of the needles.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
25
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
9
|
Reasons for withdrawal
| Measure |
Electro-acupuncture
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
Electro-acupuncture: Subjects will be placed in prone position and acupuncture sites will be cleaned with alcohol preparation. Stainless steel disposable acupuncture needle (diameter 0.25mm) will be inserted into the skin to appropriate depth needed to elicit de qi(approximately 3-4mm). Selected acupuncture points will be attached to2 leads connected to an electro-stimulator that generates 2 Hz of mixed pulsatile intervals for a total of 30 minutes. The acupuncturist will return two times during the treatment at 10 and 20 minutes with needles in situ to check on the patients and needles. Needles not attached to the electro-stimulator will be manipulated manually to elicit de qi one time during the treatment.
|
Sham Acupuncture
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.
Sham acupuncture: Will be utilizing a sham control that consists of collapsible acupuncture needle so that there is no penetration of skin. The sham needles will be place on 4 non specific body points. The electro-stimulator will be attached to the needles for 30 minutes but will not be turned on. The acupuncturist will return two times during the treatment at 10 and 20 minutes to check on the patient. The acupuncturist will touch the collapsible acupuncture needs to simulate the manipulation of the needles.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
9
|
Baseline Characteristics
Electro-acupuncture for the Prevention of Taxane Induced Myalgias and Neuropathy
Baseline characteristics by cohort
| Measure |
Electro-acupuncture
n=31 Participants
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
Electro-acupuncture: Subjects will be placed in prone position and acupuncture sites will be cleaned with alcohol preparation. Stainless steel disposable acupuncture needle (diameter 0.25mm) will be inserted into the skin to appropriate depth needed to elicit de qi(approximately 3-4mm). Selected acupuncture points will be attached to2 leads connected to an electro-stimulator that generates 2 Hz of mixed pulsatile intervals for a total of 30 minutes. The acupuncturist will return two times during the treatment at 10 and 20 minutes with needles in situ to check on the patients and needles. Needles not attached to the electro-stimulator will be manipulated manually to elicit de qi one time during the treatment.
|
Sham Acupuncture
n=32 Participants
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.
Sham acupuncture: Will be utilizing a sham control that consists of collapsible acupuncture needle so that there is no penetration of skin. The sham needles will be place on 4 non specific body points. The electro-stimulator will be attached to the needles for 30 minutes but will not be turned on. The acupuncturist will return two times during the treatment at 10 and 20 minutes to check on the patient. The acupuncturist will touch the collapsible acupuncture needs to simulate the manipulation of the needles.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.8 Years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
48.3 Years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
50.1 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic White
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African America
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Breast Cancer Type
Invasive ductal carcinoma
|
25 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Breast Cancer Type
Invasive lobular carcinoma
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Breast Cancer Type
Sarcomatoid
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
ER/PR status
Negative
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
ER/PR status
Positive
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
HER2 status
Negative
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
HER2 status
Positive
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Breast Cancer Stage
Stage I Breast Cancer
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Breast Cancer Stage
Stage II Breast Cancer
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Breast Cancer Stage
Stage III Breast Cancer
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Tumor Grade
Well differentiated
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Tumor Grade
Moderately differentiated
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Tumor Grade
Poorly differentiated
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Body mass index
|
27.6 kg/m^2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 7.1 • n=7 Participants
|
28.6 kg/m^2
STANDARD_DEVIATION 6.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 16 weeksThe change in neuropathic pain, as measured by the mean Brief Pain Inventory-Short Form (BPI-SF) worst pain score, from baseline to 16 weeks, in the study group that received electro-acupuncture (intervention), was compared to the change in neuropathic pain in the study group that received sham acupuncture (control). Scores range from 0 (no pain)-10 (worst pain) with a higher score indicating worse outcome.
Outcome measures
| Measure |
Electro-acupuncture
n=25 Participants
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
Electro-acupuncture: Subjects will be placed in prone position and acupuncture sites will be cleaned with alcohol preparation. Stainless steel disposable acupuncture needle (diameter 0.25mm) will be inserted into the skin to appropriate depth needed to elicit de qi(approximately 3-4mm). Selected acupuncture points will be attached to2 leads connected to an electro-stimulator that generates 2 Hz of mixed pulsatile intervals for a total of 30 minutes. The acupuncturist will return two times during the treatment at 10 and 20 minutes with needles in situ to check on the patients and needles. Needles not attached to the electro-stimulator will be manipulated manually to elicit de qi one time during the treatment.
|
Sham Acupuncture
n=23 Participants
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.
Sham acupuncture: Will be utilizing a sham control that consists of collapsible acupuncture needle so that there is no penetration of skin. The sham needles will be place on 4 non specific body points. The electro-stimulator will be attached to the needles for 30 minutes but will not be turned on. The acupuncturist will return two times during the treatment at 10 and 20 minutes to check on the patient. The acupuncturist will touch the collapsible acupuncture needs to simulate the manipulation of the needles.
|
|---|---|---|
|
Change in Brief Pain Inventory-Short Form Score
|
1.6 Score on a scale
Standard Deviation 3
|
0.6 Score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline, 16 weeksThe change in the quality of life as measured by Functional Assessment of Cancer Therapy- Taxane (FACT-TAX) quality of life assessment, collected at baseline and 16 weeks, as compared between the intervention and control study groups (electro acupuncture and sham acupuncture). is a validated self reported instrument used to measure self reported neuropathic symptoms among patients undergoing taxane therapy. There are four quality of life (QOL) domains as part of the FACT that include physical well being, social well being, emotional well being and functional well being. The taxane subscale combines a validated 11 item neurotoxicity subscale with 5 additional questions assessing symptoms related to arthralgias, myalgias and skin changes. The FACT-TAX scale ranges from 0-64 with five response levels (0= very much, 4 = not at all). Higher scores indicate better quality of life or fewer symptoms.
Outcome measures
| Measure |
Electro-acupuncture
n=25 Participants
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
Electro-acupuncture: Subjects will be placed in prone position and acupuncture sites will be cleaned with alcohol preparation. Stainless steel disposable acupuncture needle (diameter 0.25mm) will be inserted into the skin to appropriate depth needed to elicit de qi(approximately 3-4mm). Selected acupuncture points will be attached to2 leads connected to an electro-stimulator that generates 2 Hz of mixed pulsatile intervals for a total of 30 minutes. The acupuncturist will return two times during the treatment at 10 and 20 minutes with needles in situ to check on the patients and needles. Needles not attached to the electro-stimulator will be manipulated manually to elicit de qi one time during the treatment.
|
Sham Acupuncture
n=23 Participants
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.
Sham acupuncture: Will be utilizing a sham control that consists of collapsible acupuncture needle so that there is no penetration of skin. The sham needles will be place on 4 non specific body points. The electro-stimulator will be attached to the needles for 30 minutes but will not be turned on. The acupuncturist will return two times during the treatment at 10 and 20 minutes to check on the patient. The acupuncturist will touch the collapsible acupuncture needs to simulate the manipulation of the needles.
|
|---|---|---|
|
Change in FACT-TAX Score
|
-9.4 Score on a scale
Standard Deviation 11
|
-8.4 Score on a scale
Standard Deviation 9.8
|
Adverse Events
Electro-acupuncture
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Acupuncture
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Electro-acupuncture
n=31 participants at risk
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture.
Electro-acupuncture: Subjects will be placed in prone position and acupuncture sites will be cleaned with alcohol preparation. Stainless steel disposable acupuncture needle (diameter 0.25mm) will be inserted into the skin to appropriate depth needed to elicit de qi(approximately 3-4mm). Selected acupuncture points will be attached to2 leads connected to an electro-stimulator that generates 2 Hz of mixed pulsatile intervals for a total of 30 minutes. The acupuncturist will return two times during the treatment at 10 and 20 minutes with needles in situ to check on the patients and needles. Needles not attached to the electro-stimulator will be manipulated manually to elicit de qi one time during the treatment.
|
Sham Acupuncture
n=32 participants at risk
Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture.
Sham acupuncture: Will be utilizing a sham control that consists of collapsible acupuncture needle so that there is no penetration of skin. The sham needles will be place on 4 non specific body points. The electro-stimulator will be attached to the needles for 30 minutes but will not be turned on. The acupuncturist will return two times during the treatment at 10 and 20 minutes to check on the patient. The acupuncturist will touch the collapsible acupuncture needs to simulate the manipulation of the needles.
|
|---|---|---|
|
Investigations
Investigations - Other, specify
|
3.2%
1/31 • Number of events 1
|
0.00%
0/32
|
Additional Information
Dawn Hershman
Columbia University Irving Medical Center
Phone: 212-342-5162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place