Acupuncture for Peripheral Neuropathy
Dana Farber Cancer Institute, Boston, MA
Targeting 6 different conditionsAcupuncture +1 moreN/ARecruitingLed by Weidong Lu, MB, MPH, PhDResearch Sponsored by Dana-Farber Cancer InstituteEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow upspre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is studying whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy in people with breast cancer. It will also study if it improves quality of life. Funding is provided by CIMI of S.Korea.
Eligible Conditions
- Chemotherapy-induced Peripheral Neuropathy
- Acupuncture
- Breast Cancer
- Breast Cancer Stage 1
- Breast Cancer, Stage II
- Breast Cancer, Stage III
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow ups ~ pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score
Secondary outcome measures
Changes in mean scores of pain intensity
Changes in the total and subscales of EORTC QLQ-C30
Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI)
+4 moreSide effects data
From 2013 Phase 1 & 2 trial • 104 Patients • NCT013058112%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AcupunctureExperimental Treatment1 Intervention
Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline.
40 participants will be randomized into the acupuncture Arm:
The acupuncture arm will receive a standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).
Group II: Nature scenery videos with relaxation exerciseActive Control1 Intervention
Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline.
40 Participants will be randomized into the Control Arm:
The control arm will receive and watch videos with nature scenery with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture
2011
Completed Phase 3
~1240
Find a site
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,040 Previous Clinical Trials
763,679 Total Patients Enrolled
The Comprehensive and Integrative Medicine Institute of South KoreaOTHER
3 Previous Clinical Trials
140 Total Patients Enrolled
Weidong Lu, MB, MPH, PhDPrincipal Investigator
Dana-Farber Cancer Institute2 Previous Clinical Trials
68 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the capacity of this clinical investigation?
"Affirmative, the details present on clinicaltrials.gov indicate that recruitment for this experiment is underway. It was initially posted to the website September 8th 2022 and has been subsequently updated December 21st of same year. The aim is to find 80 patients from a single site."
Answered by AI
Are there any remaining vacancies for participants in this clinical study?
"Correct. According to the information presented on clinicaltrials.gov, this medical trial is in search of 80 participants from a single location and was first advertised on September 8th 2022 with its most recent update made December 21st 2022."
Answered by AI
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