Breast Cancer, Neuropathy
Conditions
Keywords
taxane induced neuropathy, taxane induced myalgias, electro-acupuncture
Brief summary
This study seeks to determine if 12 weeks of weekly electro-acupuncture will prevent or decrease neuropathic pain in breast cancer patients receiving 12 weekly treatments of taxane treatment.
Detailed description
Chemotherapy induced neuropathy (CIN) is a common and disabling toxicity of cytotoxic chemotherapy. Depending on the drug, it is often irreversible even after the offending agent is removed. The consequence of terminating effective anti-tumor therapy or dose reduction can be catastrophic to the effect of a patient's cancer treatment. Given the morbidity of taxane induced neuropathy, the lack of effective preventative treatment for taxane induce neuropathy and the safety of acupuncture, it is reasonable to test the efficacy of this non pharmacological intervention in woman with Stage I-III breast cancer receiving adjuvant or neo-adjuvant weekly paclitaxel for 12 weeks.
Interventions
DEVICEElectro-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.
DEVICESham 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.
Sponsors
Breast Cancer Research Foundation
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>21 years * History of stage I-III breast cancer * Patient scheduled to be receiving weekly adjuvant or neo-adjuvant paclitaxel for 12 weeks * Signed informed consent
Exclusion criteria
* Previous treatment with acupuncture in the last 12 months * Diabetic Neuropathy or other neurological conditions * Inflammatory, metabolic or neuropathic arthropathies * Current narcotic use * Severe concomitant illnesses * Severe coagulopathy or bleeding disorder * Dermatological disease within the acupuncture area * Have a pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Pain Inventory-Short Form Score | Baseline, 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in FACT-TAX Score | Baseline, 16 weeks | The 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 32 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 9 |
Baseline characteristics
| Characteristic | Electro-acupuncture | Sham Acupuncture | Total |
|---|---|---|---|
| Age, Continuous | 51.8 Years STANDARD_DEVIATION 10.7 | 48.3 Years STANDARD_DEVIATION 12 | 50.1 Years STANDARD_DEVIATION 11.4 |
| Body mass index | 27.6 kg/m^2 STANDARD_DEVIATION 6.3 | 29.5 kg/m^2 STANDARD_DEVIATION 7.1 | 28.6 kg/m^2 STANDARD_DEVIATION 6.7 |
| Breast Cancer Stage Stage I Breast Cancer | 2 Participants | 4 Participants | 6 Participants |
| Breast Cancer Stage Stage II Breast Cancer | 26 Participants | 19 Participants | 45 Participants |
| Breast Cancer Stage Stage III Breast Cancer | 3 Participants | 9 Participants | 12 Participants |
| Breast Cancer Type Invasive ductal carcinoma | 25 Participants | 27 Participants | 52 Participants |
| Breast Cancer Type Invasive lobular carcinoma | 5 Participants | 5 Participants | 10 Participants |
| Breast Cancer Type Sarcomatoid | 1 Participants | 0 Participants | 1 Participants |
| ER/PR status Negative | 7 Participants | 8 Participants | 15 Participants |
| ER/PR status Positive | 24 Participants | 24 Participants | 48 Participants |
| HER2 status Negative | 25 Participants | 22 Participants | 47 Participants |
| HER2 status Positive | 6 Participants | 10 Participants | 16 Participants |
| Race/Ethnicity, Customized African America | 10 Participants | 6 Participants | 16 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 13 Participants | 14 Participants | 27 Participants |
| Race/Ethnicity, Customized Non-hispanic White | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Female | 31 Participants | 32 Participants | 63 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Tumor Grade Moderately differentiated | 14 Participants | 15 Participants | 29 Participants |
| Tumor Grade Poorly differentiated | 15 Participants | 17 Participants | 32 Participants |
| Tumor Grade Well differentiated | 2 Participants | 0 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 1 / 31 | 0 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
Primary
Change in Brief Pain Inventory-Short Form Score
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.
Time frame: Baseline, 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electro-acupuncture | Change in Brief Pain Inventory-Short Form Score | 1.6 Score on a scale | Standard Deviation 3 |
| Sham Acupuncture | Change in Brief Pain Inventory-Short Form Score | 0.6 Score on a scale | Standard Deviation 2.1 |
p-value: 0.2595% CI: [0.9, 1.5]Regression, Logistic
Secondary
Change in FACT-TAX Score
The 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.
Time frame: Baseline, 16 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electro-acupuncture | Change in FACT-TAX Score | -9.4 Score on a scale | Standard Deviation 11 |
| Sham Acupuncture | Change in FACT-TAX Score | -8.4 Score on a scale | Standard Deviation 9.8 |
p-value: 0.0995% CI: [0.97, 1.62]Regression, Logistic