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Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

Primary Purpose

Neuropathy;Peripheral, Chemotherapy-induced Peripheral Neuropathy, Neuropathy

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Voxx Human Performance Technology Socks

Placebo Socks

About this trial

This is an interventional supportive care trial for Neuropathy;Peripheral focused on measuring Chemo-induced Peripheral Neuropathy, Voxx Socks, Voxx Human Performance Technology, Voxx HPT

Eligibility Criteria

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

Inclusion Criteria:

Diagnosed with cancer, stage 1-4.
Completed taxane- or platinum-based chemotherapy, vinca alkaloids, or bortezomib at least three months (90 days) ago. Current use of anti-estrogen therapy, Herceptin, or PARP inhibitors is okay.
Clinical diagnosis of chemotherapy-induced peripheral neuropathy by clinician. This will be based on symptom history (paresthesias, dysesthesias, allodynia), loss of deep tendon reflexes, decreased vibratory sensation, or the presence of symmetrical stocking-glove numbness or paresthesias beginning after neurotoxic chemotherapy.
Self-reported average neuropathic pain score of at least 4 on a 10-point scale over the past 1 month.
Age ≥ 18 years
Concomitant use of analgesics is permitted if the dose has been stable for at least 2 weeks prior to study enrollment (no new analgesics have been added, discontinued, or changed in the 2 weeks prior to randomization).
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain injury, or stroke, as assessed by the treating physician.
Neuropathy related to abnormal thyroid stimulating hormone or cobalamin levels as assessed by treating physician.
Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major eating disorder, as assessed by the treating physician.
Currently participating in another chemotherapy-induced peripheral neuropathy-targeted program or trial.
Participated in a non-pharmacologic therapy specifically for the treatment of chemotherapy-induced peripheral neuropathy, including Scrambler Therapy, mindfulness meditation, or other mind-body activities within 14 days (2 weeks) prior to randomization.

Sites / Locations

Cedars Sinai Medical CenterRecruiting
CS Cancer at the Hunt Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: Voxx socks followed by placebo socks

Arm B: Placebo socks followed by Voxx socks

Arm Description

Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period)

Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period)

Outcomes

Primary Outcome Measures

Change in subjective measurement of chemotherapy-induced peripheral neuropathy

Impact on chemotherapy-induced peripheral neuropathy will be subjectively measured by changes in scores on the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity Subscale. The minimum value is 0 and maximum value is 44, and a lower score means a better outcome.

Secondary Outcome Measures

Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Modified Total Neuropathy Scale)

Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Total Neuropathy Scale clinical. The minimum value is 0 and maximum value is 24, and a lower score means a better outcome.

Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Timed Up and Go test)

Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test.

Change in quality of life measurement

Impact on quality of life will be measured by the changes in scores on the Patient-Reported Outcomes Measurement Information System 29. The minimum value is 50 and maximum value is 110, and a lower score means a better outcome.

Change in cancer-related symptom experience

Impact on cancer-related symptom experience will be measured by changes in scores on the Edmonton Symptom Assessment Scale. The minimum value is 0 and maximum value is 100, and a lower score means a better outcome.

Feasibility of Voxx Socks use

Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary.

Full Information

NCT ID

NCT04403802

First Posted

May 21, 2020

Last Updated

May 4, 2023

Sponsor

Arash Asher, MD

Collaborators

VoxxLife

1. Study Identification

Unique Protocol Identification Number

NCT04403802

Brief Title

Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

Official Title

IIT2019-08-ASHER-VOXXSOCK Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy: A Double Blind, Randomized, Controlled Crossover Trial

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 16, 2020 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Arash Asher, MD

Collaborators

VoxxLife

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a double blind, randomized, crossover pilot study of Voxx Human Performance Technology Socks versus placebo socks for the treatment of chemotherapy-induced peripheral neuropathy in patients with cancer. Patients will be randomized 1:1 to one of the following regimens: Arm A: Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period) Arm B: Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period) Patients will be evaluated at three time points using an objective neuropathy assessment as well as self-report questionnaires assessing chemotherapy-induced peripheral neuropathy, quality of life, and cancer-related symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathy;Peripheral, Chemotherapy-induced Peripheral Neuropathy, Neuropathy

Keywords

Chemo-induced Peripheral Neuropathy, Voxx Socks, Voxx Human Performance Technology, Voxx HPT

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Voxx socks followed by placebo socks

Arm Type

Experimental

Arm Description

Continuous wear of Voxx Human Performance Technology Socks for 2 weeks, followed by continuous wear of placebo socks for 2 weeks (separated by a 2-week washout period)

Arm Title

Arm B: Placebo socks followed by Voxx socks

Arm Type

Experimental

Arm Description

Continuous wear of placebo socks for 2 weeks, followed by continuous wear of Voxx Human Performance Technology Socks for 2 weeks (separated by a 2-week washout period)

Intervention Type

Device

Intervention Name(s)

Voxx Human Performance Technology Socks

Intervention Description

Voxx Human Performance Technology Socks are commercially-available socks that are drug and electrical free. The Voxx Human Performance Technology proprietary pattern is woven into a sock that is made of 70% cotton, 25% polyester, 3% spandex, and 2% nylon. Prior to the 2-week treatment window, patients will be provided with 6 pairs of Voxx Human Performance Technology socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.

Intervention Type

Device

Intervention Name(s)

Placebo Socks

Intervention Description

Placebo socks are identical to the Voxx Human Performance Technology socks but do not include the Voxx Human Performance Technology pattern woven into the sock. Placebo socks are made of the same fabric as Voxx Human Performance Technology socks and are drug and electrical free. Prior to the 2-week treatment window, patients will be provided with 6 pairs of placebo socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming.

Primary Outcome Measure Information:

Title

Change in subjective measurement of chemotherapy-induced peripheral neuropathy

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Modified Total Neuropathy Scale)

Description

Time Frame

6 weeks

Title

Change in objective measurement of chemotherapy-induced peripheral neuropathy (score on the Timed Up and Go test)

Description

Impact on chemotherapy-induced peripheral neuropathy will be objectively measured by changes in scores on the Timed Up and Go test.

Time Frame

6 weeks

Title

Change in quality of life measurement

Description

Time Frame

6 weeks

Title

Change in cancer-related symptom experience

Description

Time Frame

6 weeks

Title

Feasibility of Voxx Socks use

Description

Feasibility will be measured by the number of hours the socks are worn, as recorded in the patient's daily sock diary.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosed with cancer, stage 1-4. Completed taxane- or platinum-based chemotherapy, vinca alkaloids, or bortezomib at least three months (90 days) ago. Current use of anti-estrogen therapy, Herceptin, or PARP inhibitors is okay. Clinical diagnosis of chemotherapy-induced peripheral neuropathy by clinician. This will be based on symptom history (paresthesias, dysesthesias, allodynia), loss of deep tendon reflexes, decreased vibratory sensation, or the presence of symmetrical stocking-glove numbness or paresthesias beginning after neurotoxic chemotherapy. Self-reported average neuropathic pain score of at least 4 on a 10-point scale over the past 1 month. Age ≥ 18 years Concomitant use of analgesics is permitted if the dose has been stable for at least 2 weeks prior to study enrollment (no new analgesics have been added, discontinued, or changed in the 2 weeks prior to randomization). Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Syphilis, alcoholic neuropathy, diabetic neuropathy, neurological disorders, brain injury, or stroke, as assessed by the treating physician. Neuropathy related to abnormal thyroid stimulating hormone or cobalamin levels as assessed by treating physician. Current severe depression, suicidal ideation, bipolar disease, alcohol abuse, or major eating disorder, as assessed by the treating physician. Currently participating in another chemotherapy-induced peripheral neuropathy-targeted program or trial. Participated in a non-pharmacologic therapy specifically for the treatment of chemotherapy-induced peripheral neuropathy, including Scrambler Therapy, mindfulness meditation, or other mind-body activities within 14 days (2 weeks) prior to randomization.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chris Waring

Phone

920-217-0317

Christopher.Waring@cshs.org

First Name & Middle Initial & Last Name or Official Title & Degree

Cancer Clinical Trials Office

Phone

310-423-2133

Cancer.Trials.Info@cshs.org

Facility Information:

Facility Name

Cedars Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christopher Waring

Phone

920-217-0317

Christopher.Waring@cshs.org

First Name & Middle Initial & Last Name & Degree

Arash Asher, MD

Facility Name

CS Cancer at the Hunt Cancer Center

City

Torrance

State/Province

California

ZIP/Postal Code

90505

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Valdez

Phone

310-750-3300

Ext

73422

Sarah.Valdez@tmphysicians.com

First Name & Middle Initial & Last Name & Degree

David Chan, MD

First Name & Middle Initial & Last Name & Degree

Vanessa Dickey, MD

First Name & Middle Initial & Last Name & Degree

Hugo Hool, MD

First Name & Middle Initial & Last Name & Degree

Syed Jilani, MD

First Name & Middle Initial & Last Name & Degree

Thomas Lowe, MD

First Name & Middle Initial & Last Name & Degree

Swati Sikaria, MD

12. IPD Sharing Statement

Learn more about this trial

Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

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