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Acupuncture for Chemotherapy-Induced Peripheral Neuropathy
Phase 2
Recruiting
Led By Wanqing Iris Zhi, MD, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 weeks
Awards & highlights
Study Summary
This trial is studying whether acupuncture can help prevent TIPN from getting worse in people receiving taxane.
Who is the study for?
This trial is for English or Spanish-speaking adults over 18 with breast cancer, who are undergoing chemotherapy with taxane and have developed mild nerve pain (TIPN). They must be planning to continue this treatment and agree not to start new pain medications during the study. People can't join if they had neuropathy before starting chemo, are currently on anti-neuropathy meds, or used acupuncture recently.Check my eligibility
What is being tested?
The study tests whether real acupuncture can prevent worsening of nerve pain caused by taxane chemotherapy in breast cancer patients. Participants will receive either actual acupuncture (RA) or sham acupuncture (SA), which uses different needles and targets non-specific body areas.See study design
What are the potential side effects?
Acupuncture may cause minor side effects such as bruising, bleeding at needle sites, dizziness, fainting, or infection. However, these are generally rare and considered low-risk compared to other medical treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neuropathic Pain Scale (NPS)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: real acupuncture (RA)Active Control1 Intervention
Real Acupuncture weekly till taxane completion
Group II: sham acupuncture (SA)Placebo Group1 Intervention
Sham Acupuncture weekly till taxane completion
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,818 Total Patients Enrolled
3 Trials studying Peripheral Neuropathy
154 Patients Enrolled for Peripheral Neuropathy
Gateway for Cancer ResearchOTHER
45 Previous Clinical Trials
2,490 Total Patients Enrolled
Wanqing Iris Zhi, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree not to change my pain medication or its dose for the first 12 weeks of the study.I am currently taking medication for nerve pain.I have not used acupuncture for symptom management in the last 28 days.I have nerve pain from taxane treatment.I have been diagnosed with invasive breast cancer.I am scheduled for a 12-week chemotherapy with paclitaxel or nab-paclitaxel.I have had nerve pain or tingling in my hands or feet within the last month.I am scheduled for or have started a specific chemotherapy regimen.I am currently taking medication for nerve pain.I am 18 or older and speak English or Spanish.I am willing to follow all study procedures and accept any of the two acupuncture treatments.
Research Study Groups:
This trial has the following groups:- Group 1: real acupuncture (RA)
- Group 2: sham acupuncture (SA)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants have enrolled in this experiment thus far?
"Affirmative. Clinicaltrials.gov exhibits that this clinical trial, which was initially published on July 11th 2022, is recruiting candidates currently. 80 participants are required from 7 distinct medical sites."
Answered by AI
Are there any open enrollment opportunities for this clinical research study?
"As of now, the data posted on clinicaltrials.gov reveals that this trial is seeking out participants. This research initiative was initially shared online on July 11th 2022 and last revised at the same time."
Answered by AI
How many locations are participating in this exploration?
"Presently, the medical trial is operational in 7 different locations including Basking Ridge and Middletown. To reduce any travel associated with enrolment, participants should consider selecting a clinic located nearby."
Answered by AI
Has the FDA validated real acupuncture as an acceptable treatment?
"Our team has assessed the safety of real acupuncture to be a 2, as Phase 2 trials have revealed some indications regarding its security but none in terms of efficacy."
Answered by AI
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