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| Name | Class |
|---|---|
| Breast Cancer Research Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electro-acupuncture | Experimental | Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with electro-acupuncture. |
|
| Sham acupuncture | Sham Comparator | Subjects will receive 45 minute sessions scheduled once a week for 12 weeks with sham acupuncture. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electro-acupuncture | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn L Hershman, MD, MS | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 16 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Investigations - Other, specify | Investigations | Non-systematic Assessment | A grade 1 acupuncture needle site reaction with discomfort, minor swelling, and bruising after acupuncture needle withdrawal. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dawn Hershman | Columbia University Irving Medical Center | 212-342-5162 | dlh23@cumc.columbia.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Sham acupuncture | Device | 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. |
|
| Baseline, 16 weeks |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Breast Cancer Type | Count of Participants | Participants |
|
| ER/PR status | Count of Participants | Participants |
|
| HER2 status | Count of Participants | Participants |
|
| Breast Cancer Stage | Breast cancer staging performed based on standard of care diagnostic procedures outside of this trial. A lower breast cancer stage (Stage 1) indicates a less advanced stage of cancer. | Count of Participants | Participants |
|
| Tumor Grade | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| OG001 | 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. |
|
|
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| 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, 16 weeks |
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| 0 |
| 31 |
| 0 |
| 31 |
| 1 |
| 31 |
| EG001 | 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. | 0 | 32 | 0 | 32 | 0 | 32 |
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| D017437 |
| Skin and Connective Tissue Diseases |