Anatomic Stage I Breast Cancer AJCC v8NCT05368428
Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
A study testing Transcutaneous Electrical Nerve Stimulation in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Emory University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesUnited States
- Study dates
- 19 Oct 2022to 18 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven stage I-III breast cancer actively undergoing neoadjuvant or adjuvant chemotherapy regimen that contains paclitaxel or docetaxel.
- At least Common Terminology Criteria for Adverse Events (CTCAE) grade 1 CIPN in hands or feet attributed to taxane chemotherapy.
- Actively undergoing paclitaxel or docetaxel with plans to continue during the two-week TENS treatment.
- Age >= 18 years
- For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to starting TENS
- Given the potential concern that TENS could induce uterine contractions or interfere with fetal cardiac conduction, female of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
Show all 11Show fewer
- Female of childbearing 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 TENS treatment. Should a woman become pregnant or suspect she is pregnant during the two weeks of TENS, she should inform her treating physician immediately. A female of childbearing potential (FCBP) is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Willingness and ability of the subject to comply with scheduled visits, TENS administration plan, other study procedures, and study restrictions.
- Evidence of a personally signed informed consent indicating that the subject has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation
- Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up
- 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.
Who cannot join
- Skin wounds, skin breakdown or edema at the site of TENS electrode pad placement
- History of epilepsy
- Implanted electronic device including a cardiac pacemaker, defibrillator, pain pump etc.
- Pre-existing neuropathy
- Prior exposure to neurotoxic chemotherapy
- Previous use of TENS for CIPN
- Prisoners or an adult who is unable to consent
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
About this study
Official title: Single-Institution Trial Investigating the Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) in Taxane Induced Peripheral Neuropathy (CIPN) in Patients With Early Stage Breast Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of daily transcutaneous electrical nerve stimulation (TENS) by measuring participant adherence to TENS for two weeks.
SECONDARY OBJECTIVES:
- To evaluate the change in patient reported outcome (PRO) measures of symptoms (e.g. pain, tingling, numbness) and functional impairment.
II. To evaluate the change in objective measures of neuropathy over the study period through bedside monofilament testing.
TERTIARY/EXPLORATORY OBJECTIVES:
- To collect data on the type and use frequency of non-TENS chemotherapy-induced peripheral neuropathy (CIPN) treatments (e.g. neuropathic agents and doses) both at baseline and over the duration of the trial (six weeks).
II. To measure the number of chemotherapy dose-limiting events (dose reductions, delays, discontinuations) over the duration of the trial.
OUTLINE:
Patients undergo TENS therapy at home daily over 1 hour for 14 days in the absence of unacceptable toxicity.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Being tested
- Transcutaneous Electrical Nerve Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationOther
Also called TENS, transcutaneous electric nerve stimulation
Undergo TENS
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (TENS) | Experimental | Patients undergo TENS therapy daily over 1 hour for 14 days in the absence of disease progression or unacceptable toxicity. Receives: Other: Transcutaneous Electrical Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks
Adherence for each trial participant will be calculated by summing the number of one-hour TENS sessions completed and dividing by 14 total treatments. Adherence for the cohort will be summarized descriptively using descriptive statistics.
Measured: Up to 2 weeks
Secondary outcomes (2)
Change in Patient Reported Outcomes Measurement Information System 29 score
Change in Patient Reported Outcomes Measurement Information System 29 score at two and six weeks compared to baseline
- Physical Function scored on a scale from "without any difficulty" (maximum value) to "unable to do" (minimum value)
- Anxiety scored on a scale from "always" (maximum value) to "never" (minimum value)
- Depression scored on a scale from "always"(maximum value) to "never" (minimum value)
- Fatigue scored on a scale of "very much" (maximum value) to "not at all" (minimum value)
- Sleep Disturbance scored on a scale from "very good" (maximum value) to "very poor" (minimum value)
- Ability to Participate in Social Roles and Activities" scored on a scale from "never" (maximum value) to "always" (minimum value)
- Pain Interference scored on a scale from "very much" (maximum value) to "not at all" (minimum value)
- Pain Intensity scored on a scale of 0-10, where "10" is the maximum value and "0" is the minimum value.
Measured: At baseline and 2 and 6 weeks
Change in Monofilament Testing
Testing at two and six weeks compared to baseline.
Measured: At baseline and 2 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start19 Oct 2022
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Why it stopped: PI Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Manali Bhave, Emory University
- Investigators
- Manali Bhave, MD, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368428
- Sponsor's protocol ID
- STUDY00003705
- Other IDs
- NCI-2022-01726, STUDY00003705, WINSHIP5501-21, P30CA138292
- Status last verified
- May 2026
- First submitted
- 5 May 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Institution Trial Investigating the Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) in Taxane Induced Peripheral Neuropathy (CIPN) in Patients With Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT05368428
- Acronym / sponsor ID
- STUDY00003705
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Decision
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the feasibility of daily transcutaneous electrical nerve stimulation (TENS) by measuring participant adherence to TENS for two weeks.
SECONDARY OBJECTIVES:
- To evaluate the change in patient reported outcome (PRO) measures of symptoms (e.g. pain, tingling, numbness) and functional impairment.
II. To evaluate the change in objective measures of neuropathy over the study period through bedside monofilament testing.
TERTIARY/EXPLORATORY OBJECTIVES:
- To collect data on the type and use frequency of non-TENS chemotherapy-induced peripheral neuropathy (CIPN) treatments (e.g. neuropathic agents and doses) both at baseline and over the duration of the trial (six weeks).
II. To measure the number of chemotherapy dose-limiting events (dose reductions, delays, discontinuations) over the duration of the trial.
OUTLINE:
Patients undergo TENS therapy at home daily over 1 hour for 14 days in the absence of unacceptable toxicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (TENS) | Experimental | Other: Transcutaneous Electrical Nerve StimulationPatients undergo TENS therapy daily over 1 hour for 14 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Biopsy proven stage I-III breast cancer actively undergoing neoadjuvant or adjuvant chemotherapy regimen that contains paclitaxel or docetaxel.
- At least Common Terminology Criteria for Adverse Events (CTCAE) grade 1 CIPN in hands or feet attributed to taxane chemotherapy.
- Actively undergoing paclitaxel or docetaxel with plans to continue during the two-week TENS treatment.
- Age >= 18 years
- For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to starting TENS
Key exclusion criteria (8 listed)
- Skin wounds, skin breakdown or edema at the site of TENS electrode pad placement
- History of epilepsy
- Implanted electronic device including a cardiac pacemaker, defibrillator, pain pump etc.
- Pre-existing neuropathy
- Prior exposure to neurotoxic chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationAlso: TENS, transcutaneous electric nerve stimulationUndergo TENS | Other | Supportive Care (TENS) |
Primary outcome
Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks
Time frame: Up to 2 weeks
Adherence for each trial participant will be calculated by summing the number of one-hour TENS sessions completed and dividing by 14 total treatments. Adherence for the cohort will be summarized descriptively using descriptive statistics.
2 secondary outcomes
Change in Patient Reported Outcomes Measurement Information System 29 score
Time frame: At baseline and 2 and 6 weeks
Change in Monofilament Testing
Time frame: At baseline and 2 and 6 weeks
Results and safety
The study was stopped early (reason given: PI Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manali Bhave, MD principal investigator
Emory University Hospital/Winship Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.