TENS for Chemotherapy-Induced Neuropathy in Breast Cancer

Recruiting at 2 trial locations

Overseen By Manali Bhave, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must be taking: Paclitaxel, Docetaxel

Disqualifiers: Epilepsy, Implanted device, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

27 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves patients actively undergoing chemotherapy, it seems likely that you can continue your current treatment.

Is TENS safe for use in humans?

TENS (Transcutaneous Electrical Nerve Stimulation) is generally considered safe for use in humans, including those with cancer, as it involves using a mild electrical current to stimulate nerves and can be self-administered to relieve pain. ^{1 2 3 4 5}

How does the TENS treatment differ from other treatments for chemotherapy-induced neuropathy?

TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it uses mild electrical currents to stimulate nerves through electrodes placed on the skin, which can be self-administered at home. Unlike other treatments that may involve medications, TENS offers a non-drug approach to managing pain and symptoms associated with chemotherapy-induced neuropathy. ^{1 4 5 6 7}

What is the purpose of this trial?

This phase II trial examines transcutaneous electrical nerve stimulation (TENS) in patients with stage I-III breast cancer with chemotherapy induced peripheral neuropathy. TENS is a procedure in which mild electric currents are applied to some areas of the skin to potentially improve neuropathy. This trial may help determine if TENS is feasible and effective for the treatment of peripheral neuropathy symptoms while on chemotherapy.

Research Team

Manali A Bhave, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

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.

Inclusion Criteria

I am mentally and physically able to follow the study's requirements.

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.

Exclusion Criteria

I have a history of epilepsy.

I have skin issues where the TENS pads would go.

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo TENS therapy at home daily over 1 hour for 14 days

2 weeks

Daily home sessions

Follow-up

Participants are monitored for changes in symptoms and functional impairment, with assessments at 2 and 6 weeks

4 weeks

Assessments at 2 and 6 weeks

Treatment Details

Interventions

• Transcutaneous Electrical Nerve Stimulation

Trial Overview 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.

Participant Groups

Group I: Supportive Care (TENS) Experimental Treatment 1 Intervention

Patients undergo TENS therapy daily over 1 hour for 14 days in the absence of disease progression or unacceptable toxicity.

Transcutaneous Electrical Nerve Stimulation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as TENS for:

• Pain management
• Musculoskeletal pain
• Neck pain
• Back pain
• Knee osteoarthritis pain
• Overactive bladder
• Urinary retention
• Temporomandibular joint dysfunction
• Essential tremor

Approved in European Union as TENS for:

• Pain management
• Musculoskeletal pain
• Neck pain
• Back pain
• Knee osteoarthritis pain
• Overactive bladder
• Urinary retention
• Temporomandibular joint dysfunction
• Essential tremor

Approved in Canada as TENS for:

• Pain management
• Musculoskeletal pain
• Neck pain
• Back pain
• Knee osteoarthritis pain
• Overactive bladder
• Urinary retention
• Temporomandibular joint dysfunction
• Essential tremor

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A single-arm study involving 29 patients demonstrated that transcutaneous electrical nerve stimulation (TENS) is feasible and acceptable for treating chemotherapy-induced peripheral neuropathy (CIPN), with 85% of participants completing the 6-week study.

Participants experienced significant improvements in various symptoms of CIPN, including a 52% reduction in pain and a 30% reduction in tingling, suggesting that TENS could be an effective home-based treatment option for managing CIPN after chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless transcutaneous electrical nerve stimulation device for chemotherapy-induced peripheral neuropathy: an open-label feasibility study. Gewandter, JS., Chaudari, J., Ibegbu, C., et al.[2021]

In a pilot study involving 20 patients with cancer pain, transcutaneous electrical nerve stimulation (TENS) was found to be safe, with 85% of patients using intensity-modulated TENS (IMT) reporting at least slight pain improvement compared to 50% with placebo TENS (PBT).

However, the overall change in average pain intensity did not significantly differ between IMT and PBT, suggesting that while TENS may be desired by patients, it may not provide greater analgesic effects than placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. Siemens, W., Boehlke, C., Bennett, MI., et al.[2021]

A randomized clinical trial involving 142 participants evaluated the efficacy of a wearable, app-controlled TENS device for treating chemotherapy-induced peripheral neuropathy (CIPN), showing promising results for pain and cramping symptoms, although the primary outcome did not reach statistical significance.

The study demonstrated that conducting a trial of TENS for CIPN is feasible within the National Cancer Institute Community Oncology Research Program, indicating a strong basis for future confirmatory trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wireless transcutaneous electric nerve stimulation (TENS) for chronic chemotherapy-induced peripheral neuropathy (CIPN): a proof-of-concept randomized clinical trial. Gewandter, JS., Culakova, E., Davis, JN., et al.[2023]

In a study involving 24 cancer patients undergoing chemotherapy, Transcutaneous Electrical Nerve Stimulation (TENS) did not show any significant benefits in reducing symptoms of Chemotherapy-induced Peripheral Neuropathy compared to a placebo.

Despite the lack of efficacy, TENS did not worsen symptoms during subsequent chemotherapy cycles, indicating it may be safe to use without increasing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical nerve stimulation on chemotherapy-induced peripheral neuropathy symptoms (CIPN): a preliminary case-control study. Tonezzer, T., Caffaro, LAM., Menon, KRS., et al.[2020]

Transcutaneous electrical nerve stimulation (TENS) is a safe method that cancer patients can use to potentially relieve pain and chemotherapy-induced peripheral neuropathy, based on a systematic review of seven studies involving 260 patients.

While the evidence suggests TENS may help with pain relief, the studies varied widely in design and quality, indicating a need for more rigorous, multi-center trials to establish clear recommendations for its use in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Systematic Review. Püsküllüoğlu, M., Tomaszewski, KA., Grela-Wojewoda, A., et al.[2022]

In a study involving 40 lung cancer patients with cisplatin-induced neuropathy, transcutaneous electrical nerve stimulation (TENS) therapy significantly reduced neuropathic pain and improved quality of life, as measured by various questionnaires.

Patients reported a notable decrease in pain intensity and an increase in quality of life scores after four weeks of TENS therapy, indicating its potential as an effective symptomatic treatment for this common chemotherapy side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TENS Improves Cisplatin-Induced Neuropathy in Lung Cancer Patients. Tomanovic Vujadinovic, S., Ilic, N., Selakovic, I., et al.[2023]

A phase 2 study involving 27 cancer patients with chemotherapy-induced peripheral neuropathy (CIPN) demonstrated that acupuncture-like transcutaneous nerve stimulation (ALTENS) significantly improved neuropathy symptoms, as indicated by a reduction in the Modified Total Neuropathy Score (mTNS) over 6 months (p<0.001).

ALTENS was well-tolerated with no significant side effects reported, suggesting it is a safe treatment option for managing CIPN symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 Study of Acupuncture-Like Transcutaneous Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy. Wong, R., Major, P., Sagar, S.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Wireless transcutaneous electrical nerve stimulation device for chemotherapy-induced peripheral neuropathy: an open-label feasibility study. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Wireless transcutaneous electric nerve stimulation (TENS) for chronic chemotherapy-induced peripheral neuropathy (CIPN): a proof-of-concept randomized clinical trial. [2023]

4. Japan pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electrical nerve stimulation on chemotherapy-induced peripheral neuropathy symptoms (CIPN): a preliminary case-control study. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Systematic Review. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

TENS Improves Cisplatin-Induced Neuropathy in Lung Cancer Patients. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Phase 2 Study of Acupuncture-Like Transcutaneous Nerve Stimulation for Chemotherapy-Induced Peripheral Neuropathy. [2018]