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Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer

Primary Purpose

Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous Electrical Nerve Stimulation
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anatomic Stage I Breast Cancer AJCC v8

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Emory University Hospital MidtownRecruiting
  • Emory University/Winship Cancer InstituteRecruiting
  • Emory Saint Joseph's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive Care (TENS)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in Monofilament Testing
Testing at two and six weeks compared to baseline.

Full Information

First Posted
May 5, 2022
Last Updated
June 6, 2023
Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05368428
Brief Title
Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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: I. To evaluate the feasibility of daily transcutaneous electrical nerve stimulation (TENS) by measuring participant adherence to TENS for two weeks. SECONDARY OBJECTIVES: I. 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: I. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Chemotherapy-Induced Peripheral Neuropathy, Early Stage Breast Carcinoma, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Supportive Care (TENS)
Arm Type
Experimental
Arm Description
Patients undergo TENS therapy daily over 1 hour for 14 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Other
Intervention Name(s)
Transcutaneous Electrical Nerve Stimulation
Other Intervention Name(s)
TENS, transcutaneous electric nerve stimulation
Intervention Description
Undergo TENS
Primary Outcome Measure Information:
Title
Evaluate the Feasibility of Daily TENS by Measuring Participant Adherence to TENS for Two Weeks
Description
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.
Time Frame
Up to 2 weeks
Secondary Outcome Measure Information:
Title
Change in Patient Reported Outcomes Measurement Information System 29 score
Description
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.
Time Frame
At baseline and 2 and 6 weeks
Title
Change in Monofilament Testing
Description
Testing at two and six weeks compared to baseline.
Time Frame
At baseline and 2 and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manali Bhave, MD
Phone
404-778-1900
Email
manali.ajay.bhave@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manali Bhave, MD
Organizational Affiliation
Emory University Hospital/Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Trumbull
Phone
404-778-4389
Email
ashley.lynn.trumbull@emory.edu
First Name & Middle Initial & Last Name & Degree
L.
First Name & Middle Initial & Last Name & Degree
Manali Bhave, MD
Facility Name
Emory University/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Trumbull
Phone
404-778-4389
Email
ashley.lynn.trumbull@emory.edu
First Name & Middle Initial & Last Name & Degree
Manali Bhave, MD
Facility Name
Emory Saint Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Trumbull
Phone
404-778-4389
Email
ashley.lynn.trumbull@emory.edu
First Name & Middle Initial & Last Name & Degree
Manali Bhave, MD

12. IPD Sharing Statement

Learn more about this trial

Transcutaneous Electrical Nerve Stimulation in Chemotherapy Induced Peripheral Neuropathy in Patients With Stage I-III Early Stage Breast Cancer

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