The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment
Primary Purpose
Breast Cancer, Taxane-Induced Peripheral Neuropathy
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Real Acupuncture
Sham Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Acupuncture, Peripheral Neuropathy, 22-197
Eligibility Criteria
Inclusion Criteria:
Screening Phase:
- English or Spanish-proficient men and women aged ≥18 years
- Histological diagnoses of invasive carcinoma of the breast
- Plan to receive curative intent chemotherapy regimen containing 12 weeks weekly paclitaxel or nab-paclitaxel as standard of care
Intervention Phase:
- TIPN grade ≥1 based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, developed while receiving taxane
- ≥ 4 weeks of weekly paclitaxel or nab-paclitaxe planned, as standard of care and at treating physician's discretion
- Willing to adhere to requirement that no new pain medication or dose changes be taken throughout the first 12 weeks of the study period
- Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments
Exclusion Criteria:
Screening Phase:
- Pre-existing peripheral neuropathy within 28 days of screening consent
- Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
Intervention Phase:
- Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
- Use of acupuncture for symptom management within 28 days of intervention consent
Sites / Locations
- Memorial Sloan Kettering Basking RidgeRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Memorial Sloan Kettering Suffolk- CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering NassauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
real acupuncture (RA)
sham acupuncture (SA)
Arm Description
Real Acupuncture weekly till taxane completion
Sham Acupuncture weekly till taxane completion
Outcomes
Primary Outcome Measures
Neuropathic Pain Scale (NPS)
Evaluate the effectiveness of real acupuncture versus sham acupuncture in preventing TIPN progression as measured by the Neuropathic Pain Scale (NPS) in patients with early stage breast cancer who are receiving curative intent weekly taxane containing regimen and who have grade ≥ 1 TIPN
Secondary Outcome Measures
Full Information
NCT ID
NCT05458284
First Posted
July 11, 2022
Last Updated
June 23, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Gateway for Cancer Research
1. Study Identification
Unique Protocol Identification Number
NCT05458284
Brief Title
The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment
Official Title
Acupuncture for Taxane-Induced Peripheral Neuropathy Prevention (ATP): A Phase II Randomized, Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2022 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Gateway for Cancer Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (TIPN). TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. The purpose of this study is to learn if acupuncture can prevent TIPN from getting worse. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. We will compare real acupuncture (RA) to placebo (sham) acupuncture (SA). SA is done like RA, but will use different needles and target different sites or places on the body than RA. We are comparing RA to SA to learn whether RA can prevent TIPN from getting worse while receiving taxane.
Detailed Description
The study will include two phases. The first phase is the screening phase, in which patients with early stage breast cancer undergoing taxane therapy will consent and receive TIPN screening each week till they develop grade 1 or higher by CTCAE criteria. The patients with TIPN grade 1 or higher will then be consented to the intervention phase, in which patients will be randomized to receive either weekly real or sham acupuncture treatment using a standardized, semi-fixed protocol developed in our preliminary studies to improve TIPN pain. The participant may also participate in Part 2 of the study if they begin to experience TIPN but do not participate in Part 1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Taxane-Induced Peripheral Neuropathy
Keywords
Acupuncture, Peripheral Neuropathy, 22-197
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
real acupuncture (RA)
Arm Type
Active Comparator
Arm Description
Real Acupuncture weekly till taxane completion
Arm Title
sham acupuncture (SA)
Arm Type
Placebo Comparator
Arm Description
Sham Acupuncture weekly till taxane completion
Intervention Type
Procedure
Intervention Name(s)
Real Acupuncture
Intervention Description
Real Acupuncture weekly till taxane completion
Intervention Type
Other
Intervention Name(s)
Sham Acupuncture
Intervention Description
Sham Acupuncture weekly till taxane completion
Primary Outcome Measure Information:
Title
Neuropathic Pain Scale (NPS)
Description
Evaluate the effectiveness of real acupuncture versus sham acupuncture in preventing TIPN progression as measured by the Neuropathic Pain Scale (NPS) in patients with early stage breast cancer who are receiving curative intent weekly taxane containing regimen and who have grade ≥ 1 TIPN
Time Frame
at 4 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breast Cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Screening Phase:
English or Spanish-proficient men and women aged ≥18 years
Histological diagnoses of invasive carcinoma of the breast
Plan to receive curative intent chemotherapy regimen containing 12 weeks weekly paclitaxel or nab-paclitaxel as standard of care
Intervention Phase:
TIPN grade ≥1 based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, developed while receiving taxane
≥ 4 4 weeks of either weekly paclitaxel or nab-paclitaxel, or paclitaxel or abraxane with dosing every 2-3 weeks planned, as standard of care and at treating physician's discretion
Willing to adhere to requirement that no new pain medication or dose changes be taken throughout the first 12 weeks of the study period
Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments
Exclusion Criteria:
Screening Phase:
Pre-existing peripheral neuropathy within 28 days of screening consent
Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
Intervention Phase:
Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
Use of acupuncture for symptom management within 28 days of intervention consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanqing Iris Zhi, MD, PhD
Phone
631-623-4246
Email
zhiw@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Mao, MD, MSCE
Phone
646-608-8552
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wanqing Iris Zhi, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanqing Iris Zhi, MD, PhD
Phone
631-212-6055
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanqing Iris Zhi, MD, PhD
Phone
631-212-6055
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanqing Iris Zhi, MD, PhD
Phone
631-212-6055
Facility Name
Memorial Sloan Kettering Suffolk- Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanqing Iris Zhi, MD, PhD
Phone
631-212-6055
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanqing Iris Zhi, MD, PhD
Phone
631-212-6055
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanqing Iris Zhi, MD, PhD
Phone
631-623-4246
Facility Name
Memorial Sloan Kettering Nassau
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanqing Iris Zhi, MD, PhD
Phone
631-212-6055
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment
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