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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcutaneous electrical nerve stimulation (TENS), which uses mild electric currents, can alleviate nerve pain caused by chemotherapy in breast cancer patients. The researchers aim to determine if this technique effectively eases discomfort from peripheral neuropathy (nerve damage) during treatment. Participants wear a TENS device for an hour each day over two weeks. This trial suits those with stage I-III breast cancer experiencing nerve pain in their hands or feet due to chemotherapy drugs like paclitaxel or docetaxel. As an unphased study, it offers patients the chance to explore a potentially beneficial treatment for nerve pain without the constraints of traditional clinical trial phases.

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.

What prior data suggests that TENS is safe for treating chemotherapy-induced neuropathy?

Research shows that transcutaneous electrical nerve stimulation (TENS) is generally safe for patients. TENS, a non-drug treatment controlled by the patient, uses gentle electrical currents and has helped with pain in conditions similar to chemotherapy-induced nerve pain. The FDA has approved TENS in some areas for treating various types of nerve pain, indicating it is well-tolerated with minimal risk of serious side effects. Overall, TENS is considered a safe option for managing nerve-related pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Electrical Nerve Stimulation (TENS) stands out because it offers a non-drug approach to treating chemotherapy-induced neuropathy in breast cancer patients. Unlike the standard treatments that often rely on medications like antidepressants or anticonvulsants, TENS uses electrical currents to stimulate nerves, potentially reducing pain and discomfort with minimal side effects. This method is particularly appealing because it can be self-administered at home, providing a convenient and potentially safer alternative to traditional drug therapies. Researchers are excited by its potential to offer relief without the risk of medication-related side effects or interactions.

What evidence suggests that TENS is effective for chemotherapy-induced neuropathy?

Studies have shown that a device called TENS (transcutaneous electrical nerve stimulation) can help reduce symptoms of nerve damage caused by cancer treatment. One study found that daily home use of TENS eased painful symptoms for patients. However, another study found no difference between TENS and a placebo in reducing pain or numbness. Despite these mixed results, this trial tests TENS as a supportive care option because it sends mild electric currents through the skin, which might help with nerve pain. Researchers continue to explore how well this method can help people with this type of pain. ^{1 6 7 8 9}

Who Is on the Research Team?

Manali A Bhave, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-01726

Transcutaneous Electrical Nerve Stimulation in ... This trial may help determine if TENS is feasible and effective for chemotherapy induced peripheral neuropathy symptoms that develop while on chemotherapy.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5430273/

Effects of transcutaneous electrical nerve stimulation on ... [Results] The data showed no difference between active or placebo groups in terms of pain, numbness/tingling, frequency of symptoms or impact on ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12426722/

Chemotherapy-induced peripheral neuropathy in patients ... Despite these modifications and the available therapies, 44% of patients report persistent symptoms two years after CIPN diagnosis (5). CIPN ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05368428

Transcutaneous Electrical Nerve Stimulation in ... This phase II trial examines transcutaneous electrical nerve stimulation (TENS) in patients with stage I-III breast cancer with chemotherapy induced ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S152659002300617X

A Proof-of-Concept Randomized Clinical Trial Daily, home-based TENS therapy demonstrates promising efficacy for painful CIPN symptoms in this proof-of-concept randomized clinical trial.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06499103

Effect of Transcutaneous Electrical Nerve Stimulation on ... TENS is an innovative and FDA approved method in Jordan to treat a variety of neuropathic pain. It has documented effects in reducing pain related to different ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e24134

Wireless transcutaneous electric nerve stimulation (TENS) ... Preliminary efficacy evidence suggests that TENS is promising for pain and cramping from CIPN, but less likely to improve numbness and tingling.

8. mdpi.com mdpi.com/1648-9144/58/2/284

Effects of Transcutaneous Electrical Nerve Stimulation on ... TENS is a safe procedure that may be self-administered by the patients with malignancy in an attempt to relieve different types of pain.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6393221/

Wireless transcutaneous electrical nerve stimulation device for ... In conclusion, TENS is a safe, non-pharmacologic, patient-controlled therapy that if demonstrated to be efficacious would provide CIPN patients with an ...