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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

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.

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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 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

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

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.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor

1,679 Previous Clinical Trials

2,583,639 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,841 Previous Clinical Trials

41,002,862 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

~4 spots leftby Jan 2025

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