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TENS for Chemotherapy-Induced Neuropathy in Breast Cancer
N/A
Recruiting
Led By Manali Bhave, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of child bearing potential (FCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Biopsy proven stage I-III breast cancer actively undergoing neoadjuvant or adjuvant chemotherapy regimen that contains paclitaxel or docetaxel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 2 and 6 weeks
Awards & highlights
Study Summary
This trial is testing if TENS, a mild electrical current applied to the skin, can help improve neuropathy symptoms for stage I-III breast cancer patients on chemotherapy.
Who is the study for?
This trial is for women with stage I-III breast cancer experiencing nerve pain due to chemotherapy. They must be undergoing treatment with paclitaxel or docetaxel, not pregnant, able to follow the study plan, and use birth control if of childbearing age. Excluded are those with skin issues where TENS pads go, epilepsy, electronic implants like pacemakers, existing neuropathy or prior neurotoxic chemo.Check my eligibility
What is being tested?
The trial tests Transcutaneous Electrical Nerve Stimulation (TENS) on patients with early-stage breast cancer who have nerve pain from chemotherapy. It involves mild electric currents applied to the skin over two weeks to see if it eases their symptoms.See study design
What are the potential side effects?
Potential side effects of TENS may include discomfort at pad sites, muscle twitching during application, and skin irritation. However, since it's non-invasive and drug-free, serious side effects are uncommon.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control or practice abstinence during the study.
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I am currently receiving chemotherapy with paclitaxel or docetaxel for stage I-III breast cancer.
Select...
I have mild nerve pain or tingling in my hands or feet from chemotherapy.
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I am currently on paclitaxel or docetaxel and will continue it during the TENS treatment.
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I am 18 years old or older.
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I am not pregnant and have taken a test to confirm this before starting therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and 2 and 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 2 and 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks
Secondary outcome measures
Change in Monofilament Testing
Change in Patient Reported Outcomes Measurement Information System 29 score
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive Care (TENS)Experimental Treatment1 Intervention
Patients undergo TENS therapy daily over 1 hour for 14 days in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,639 Previous Clinical Trials
2,560,619 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,926,171 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,473 Patients Enrolled for Peripheral Neuropathy
Manali Bhave, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mentally and physically able to follow the study's requirements.I have a history of epilepsy.I agree to use birth control or practice abstinence during the study.I am currently receiving chemotherapy with paclitaxel or docetaxel for stage I-III breast cancer.I have mild nerve pain or tingling in my hands or feet from chemotherapy.I agree to use birth control or abstain from sex during the TENS treatment.I am willing and able to follow the study's schedule and procedures.I have skin issues where the TENS pads would go.I am currently on paclitaxel or docetaxel and will continue it during the TENS treatment.You have nerve damage before starting the study.I have been treated with chemotherapy that can affect the nerves.I have used TENS for chemotherapy-induced peripheral neuropathy.I am 18 years old or older.I am not pregnant and have taken a test to confirm this before starting therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care (TENS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
What is the participant capacity for this investigation?
"That is accurate. According to clinicaltrials.gov, the trial that was initially posted on October 19th 2022 is currently recruiting participants. 27 patients must be accepted from 3 separate medical centres."
Answered by AI
Are participants currently being enrolled for this clinical investigation?
"According to the information listed on clinicaltrials.gov, the recruitment for this trial is ongoing and continues since its original posting date of October 19th 2022. The data was last revised on November 21st 202"
Answered by AI
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