Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-07566 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC19085 | Other Identifier | University of Rochester NCORP Research Base | |
| URCC-19085 | Other Identifier | DCP | |
| URCC-19085 | Other Identifier | CTEP | |
| R21CA235389 | U.S. NIH Grant/Contract | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
This phase II trial studies the effects of transcutaneous electrical nerve stimulation (TENS) for the treatment of peripheral neuropathy caused by chemotherapy, often called chemotherapy-induced peripheral neuropathy (CIPN). Peripheral neuropathy refers to the conditions that result when nerves that carry messages to and from the brain and spinal cord from and to the rest of the body are damaged or diseased. The TENS device emits high frequency electrical stimulation through the skin and may provide relief from chronic pain.
PRIMARY OBJECTIVE:
I. Obtain efficacy estimates of daily TENS on CIPN (European Organization for Research and Treatment of Cancer-CIPN20 [EORTC-CIPN20]) to inform the design of a phase III confirmatory trial.
SECONDARY OBJECTIVES:
I. Obtain efficacy estimates of TENS on individual CIPN symptoms (i.e., hot/burning pain, sharp/shooting pain, tingling, numbness, cramping (measured daily via 0 - 10 numeric rating scale [NRS]).
II. Evaluate the feasibility of conducting, within the University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) network, a multisite, modified double-blind randomized control trial (RCT) of TENS for CIPN with physiologic assessments of descending inhibition (i.e., conditioned pain modulation [CPM] test) by assessing the proportions of (a) screened patients who enroll, (b) randomized participants who adhere to the treatment and complete the primary assessment, and (c) randomized participants who complete the CPM test.
EXPLORATORY OBJECTIVES:
I. Investigate the potential effects of TENS on balance, physical function, descending inhibition, lower limb sensation, and anxiety and depression.
II. Establish data to support the construct validity of the Treatment-Induced Neuropathy Assessment Scale (TNAS) and CIPN symptom inventory daily diary by comparison to the EORTC-CIPN20, which is the most commonly used measure of CIPN.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
GROUP II: Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Active TENS) | Experimental | Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. |
|
| Group II (Placebo TENS) | Placebo Comparator | Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Administration | Device | Wear placebo TENS device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms | Measured by the mean European Organization for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20). The effects of transcutaneous electrical nerve stimulation (TENS) on CIPN will be estimated using analysis of covariance (ANCOVA). A 20 -item patient self -report tool to assess symptoms and function in the sensory, motor and autonomic domains. Two items, Q49 and Q50, were excluded from the total score calculation. Q49 was relevant only for individuals who could drive, and Q50 was relevant only for men. 0 - 72, a higher score indicates worse neuropathy | 6 weeks after the start of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of TENS on Hot/Burning Pain | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on hot/burning pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Gewandter | University of Rochester NCORP Research Base | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Health Care System | Newark | Delaware | 19713 | United States | ||
| Lee Memorial Health System |
7 participants withdrew from the study before randomization to an arm for the following reasons: Became ineligible after registration, Lost to follow-up, Changed their mind.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group I (Active TENS) | Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. Questionnaire Administration: Ancillary studies Transcutaneous Electrical Nerve Stimulation: Wear active TENS device |
| FG001 | Group II (Placebo TENS) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Questionnaire Administration |
| Other |
Ancillary studies |
|
| Transcutaneous Electrical Nerve Stimulation | Device | Wear active TENS device |
|
|
| 6 weeks after the start of intervention |
| Effect of TENS on Sharp/Shooting Pain | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on sharp/shooting pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23) | 6 weeks after the start of intervention |
| Effect of TENS on Numbness | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on numbness will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50) | 6 weeks after the start of intervention |
| Effect of TENS on Tingling | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on tingling will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50) | 6 weeks after the start of intervention |
| Effect of TENS on Cramping | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on cramping will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18) | 6 weeks after the start of intervention |
| Fort Myers |
| Florida |
| 33905 |
| United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | 49503 | United States |
| Metro Health Hospital | Wyoming | Michigan | 49519 | United States |
| Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | 29341 | United States |
| Prisma Health Cancer Institute - Butternut | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Faris | Greenville | South Carolina | 29605 | United States |
| Prisma Health Cancer Institute - Eastside | Greenville | South Carolina | 29615 | United States |
| Gibbs Cancer Center-Pelham | Greer | South Carolina | 29651 | United States |
| Spartanburg Medical Center | Spartanburg | South Carolina | 29303 | United States |
| MGC Hematology Oncology-Union | Union | South Carolina | 29379 | United States |
| Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | 54301 | United States |
| St. Vincent Hospital Cancer Center at St. Mary's | Green Bay | Wisconsin | 54303 | United States |
| Aspirus | Wausau | Wisconsin | 54401 | United States |
Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. Questionnaire Administration: Ancillary studies Placebo Administration: Wear placebo TENS device |
| Received Intervention and Completed Baseline Assessments |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I (Active TENS) | Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. Questionnaire Administration: Ancillary studies Transcutaneous Electrical Nerve Stimulation: Wear active TENS device |
| BG001 | Group II (Placebo TENS) | Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. Placebo Administration: Wear placebo TENS device Questionnaire Administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Education level | Count of Participants | Participants |
| ||||||||||||||||
| BMI | BMI calculation formulae - For standard measures: (weight (lb) / [height (in)]^2 ) x 703, For metric measures: weight (kg) / [height (m)]^2 | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||
| Cancer Type | Count of Participants | Participants |
| ||||||||||||||||
| Neurotoxic Chemo Class | Count of Participants | Participants |
| ||||||||||||||||
| Time since Neurotoxic Chemo | Median | Inter-Quartile Range | days |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chemotherapy-induced Peripheral Neuropathy (CIPN) Symptoms | Measured by the mean European Organization for Research and Treatment of Cancer-CIPN20 (EORTC-CIPN20). The effects of transcutaneous electrical nerve stimulation (TENS) on CIPN will be estimated using analysis of covariance (ANCOVA). A 20 -item patient self -report tool to assess symptoms and function in the sensory, motor and autonomic domains. Two items, Q49 and Q50, were excluded from the total score calculation. Q49 was relevant only for individuals who could drive, and Q50 was relevant only for men. 0 - 72, a higher score indicates worse neuropathy | Participants who completed the baseline assessment were included in the analysis (N=141) except one extreme outlier that was removed from the Active TENS group due to data discordance among similar measures at baseline. | Posted | Least Squares Mean | Standard Error | score on a scale | 6 weeks after the start of intervention |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effect of TENS on Hot/Burning Pain | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on hot/burning pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Hot/Burning Pain. (N: Active TENS=22, Placebo TENS=22). | All participants who completed the study were included in the analysis, except one who did not provide Hot/Burning pain data at post-intervention. | Posted | Least Squares Mean | Standard Error | mean of a score on a scale | 6 weeks after the start of intervention |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effect of TENS on Sharp/Shooting Pain | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on sharp/shooting pain will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Sharp/Shooting Pain. (N: Active TENS=24, Placebo TENS=23) | All participants who completed the study were included in the analysis, except one who did not provide Sharp/Shooting pain data at post-intervention. | Posted | Least Squares Mean | Standard Error | mean of a score on a scale | 6 weeks after the start of intervention |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effect of TENS on Numbness | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on numbness will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Numbness. (N: Active TENS=60, Placebo TENS=50) | All participants who completed the study were included in the analysis, except one who did not provide Numbness data at post-intervention. | Posted | Least Squares Mean | Standard Error | mean of a score on a scale | 6 weeks after the start of intervention |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effect of TENS on Tingling | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on tingling will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Tingling. (N: Active TENS=55, Placebo TENS=50) | All participants who completed the study were included in the analysis, except one who did not provide Tingling pain data at post-intervention. | Posted | Least Squares Mean | Standard Error | mean of a score on a scale | 6 weeks after the start of intervention |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Effect of TENS on Cramping | Measured by the CIPN Symptom Inventory; numeric rating scale of 0-10. Higher score is worse. The effects of transcutaneous electrical nerve stimulation (TENS) on cramping will be estimated using analysis of covariance (ANCOVA) for 2 study populations: (1) Study Completers (N: Active TENS=67, Placebo TENS=62) and (2) participants who reported at least 4 out of 10 at baseline for Cramping. (N: Active TENS=18, Placebo TENS=18) | All participants who completed the study were included in the analysis, except one who did not provide Cramping pain data at post-intervention. | Posted | Least Squares Mean | Standard Error | mean of a score on a scale | 6 weeks after the start of intervention |
|
The adverse event data were collected over the intervention period. i.e. 6 weeks.
Adverse events were assessed by phone in weeks 1, 3, and 5 and at the Week 6 visit. At each participant visit and phone call, the site study staff assessed adverse events by asking participants if they have experienced any new symptoms since starting the experimental treatment. They asked specifically if any skin reactions have occurred.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (Active TENS) | Patients wear an active wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. Questionnaire Administration: Ancillary studies Transcutaneous Electrical Nerve Stimulation: Wear active TENS device | 1 | 72 | 1 | 72 | 17 | 72 |
| EG001 | Group II (Placebo TENS) | Patients wear a placebo wireless TENS device 5 hours daily for up to 6 weeks in the absence of unacceptable toxicity. Questionnaire Administration: Ancillary studies Placebo Administration: Wear placebo TENS device | 0 | 70 | 1 | 70 | 12 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease Progression | General disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bruising | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Muscle cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dysesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Paresthesia | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Muscle cramp | Nervous system disorders | Systematic Assessment |
| ||
| Burning sensation in toes | Nervous system disorders | Systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Systematic Assessment |
| ||
| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rash acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Contact Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Gewandter, PhD | University of Rochester NCORP Research Base | 585-275-2141 | Jennifer_Gewandter@urmc.rochester.edu |
| Jul 26, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 25, 2021 | Jul 26, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| High School Graduate |
|
| College Degree |
|
| Graduate Degree |
|
| Chose not to answer |
|
| GI |
|
| Hematologic |
|
| Gynecologic |
|
| Other |
|
| Taxane |
|
| Platinum and Taxane |
|
| Bortezomib |
|
| Vinca alkaloid |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|