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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
Must not have
History of epilepsy
Skin wounds, skin breakdown or edema at the site of TENS electrode pad placement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and 2 and 6 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of epilepsy.
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I have skin issues where the TENS pads would go.
Select...
I have been treated with chemotherapy that can affect the nerves.
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I have used TENS for chemotherapy-induced peripheral neuropathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and 2 and 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 2 and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks
Secondary study objectives
Change in Monofilament Testing
Change in Patient Reported Outcomes Measurement Information System 29 score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,708 Previous Clinical Trials
2,607,471 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,112,066 Total Patients Enrolled
14 Trials studying Peripheral Neuropathy
1,473 Patients Enrolled for Peripheral Neuropathy
Manali Bhave, MDPrincipal InvestigatorEmory University Hospital/Winship Cancer Institute
1 Previous Clinical Trials
29 Total Patients Enrolled

Media Library

Transcutaneous Electrical Nerve Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT05368428 — N/A
Peripheral Neuropathy Research Study Groups: Supportive Care (TENS)
Peripheral Neuropathy Clinical Trial 2023: Transcutaneous Electrical Nerve Stimulation Highlights & Side Effects. Trial Name: NCT05368428 — N/A
Transcutaneous Electrical Nerve Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05368428 — N/A
~1 spots leftby Jan 2025
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