Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer
Acupuncture for Chemotherapy-Induced Peripheral Neuropathy Among Breast Cancer Patients
4 other identifiers
interventional
23
1 country
1
Brief Summary
The goal of this study is to obtain preliminary evidence of the effect of 8 acupuncture treatments over 10 weeks in breast and GI cancer patients who are currently receiving or recently completed active neurotoxic chemotherapy and have clinically documented grade 1 or 2 neuropathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2018
CompletedFirst Posted
Study publicly available on registry
April 23, 2018
CompletedStudy Start
First participant enrolled
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2021
CompletedResults Posted
Study results publicly available
May 11, 2022
CompletedJune 1, 2022
May 1, 2022
2.5 years
April 12, 2018
February 23, 2022
May 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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)
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.
Baseline up to week 12
Secondary Outcomes (10)
Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
Baseline up to week 12
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Baseline up to week 12
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
Up to week 12
Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy
Up to week 12
Number of Cycles of Completed Chemotherapy
Up to week 12
- +5 more secondary outcomes
Study Arms (2)
Group 1 (acupuncture)
EXPERIMENTALParticipants undergo 8 45-minute acupuncture treatments over 10 weeks.
Group 2 (usual care)
ACTIVE COMPARATORParticipants receive usual care.
Interventions
Undergo acupuncture therapy
Receive usual care
Ancillary studies
Eligibility Criteria
You may qualify if:
- Breast and GI cancer stage I-III
- Currently receiving or recently completed neurotoxic chemotherapy (either adjuvant or neoadjuvant). Currently is defined as including up until when the next cycle would be delivered, that is if the patient is getting chemotherapy every week, this would include a week after their last treatment; if the patient is getting treatment every 2 weeks, this would include 2 weeks after their last treatment; if the patient is getting treatment every 3 weeks, this would include 3 weeks after their last treatment, etc. Recently completed is defined as 6 weeks after this time period. For example, if a patient was getting chemotherapy every week, this would include seven weeks after their last treatment; if the patient was getting treatment every 2 weeks, this would include 8 weeks after their last treatment; if the patient were getting treatment every 3 weeks, this would include 9 weeks after their last treatment, etc.
- Clinical symptoms of peripheral neuropathy of grade 1 or grade 2 as measured by the National Cancer Institute (NCI)-CTCAE
- Ability and willingness to understand and sign an informed consent
You may not qualify if:
- Self-reported or documented history of UNRESOLVED pre-existing peripheral neuropathy due to diabetes, human immunodeficiency virus (HIV), or other conditions.
- Unable to provide medical history.
- Male patients.
- Pregnant.
- Unwilling to receive acupuncture or unable to travel for treatments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nancy Avis, PhD
- Organization
- Wake Forest Baptist Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Avis
Wake Forest University Health Sciences
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2018
First Posted
April 23, 2018
Study Start
August 3, 2018
Primary Completion
January 21, 2021
Study Completion
February 21, 2021
Last Updated
June 1, 2022
Results First Posted
May 11, 2022
Record last verified: 2022-05