Trial Outcomes & Findings for Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy (NCT NCT04403802)

Last Updated: 2025-08-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

28 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-08-29

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A: Voxx Socks Followed by Placebo Socks 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) Voxx Human Performance Technology Socks: 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. Placebo Socks: 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.	Arm B: Placebo Socks Followed by Voxx Socks 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) Voxx Human Performance Technology Socks: 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. Placebo Socks: 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.
First 2 Week STARTED	14	14
First 2 Week COMPLETED	14	14
First 2 Week NOT COMPLETED	0	0
Second 2 Week STARTED	14	14
Second 2 Week COMPLETED	14	14
Second 2 Week NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Voxx Human Performance Technology Socks for Chemotherapy-Induced Peripheral Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Voxx Socks Followed by Placebo Socks n=14 Participants 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) Voxx Human Performance Technology Socks: 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. Placebo Socks: 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.	Arm B: Placebo Socks Followed by Voxx Socks n=14 Participants 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) Voxx Human Performance Technology Socks: 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. Placebo Socks: 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.	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Age, Continuous	58.28571 years STANDARD_DEVIATION 16.44304 • n=5 Participants	59.85714 years STANDARD_DEVIATION 10.91123 • n=7 Participants	59.071429 years STANDARD_DEVIATION 13.716518 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Voxx Human Performance Technology Socks n=28 Participants Continuous wear of Voxx Human Performance Technology Socks for 2 weeks Voxx Human Performance Technology Socks: 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.	Placebo Socks n=28 Participants Continuous wear of placebo socks for 2 weeks Placebo Socks: 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.
Change in Subjective Measurement of Chemotherapy-induced Peripheral Neuropathy	27.32 score on a scale Standard Deviation 8.03	27.94 score on a scale Standard Deviation 8.72

SECONDARY outcome

Timeframe: 6 weeks

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 28, and a lower score means a better outcome.

Outcome measures

Outcome measures
Measure	Voxx Human Performance Technology Socks n=27 Participants Continuous wear of Voxx Human Performance Technology Socks for 2 weeks Voxx Human Performance Technology Socks: 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.	Placebo Socks n=26 Participants Continuous wear of placebo socks for 2 weeks Placebo Socks: 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.
Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Modified Total Neuropathy Scale)	8.22 score on a scale Standard Deviation 2.36	8.88 score on a scale Standard Deviation 3.13

SECONDARY outcome

Timeframe: 6 weeks

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

Outcome measures

Outcome measures
Measure	Voxx Human Performance Technology Socks n=27 Participants Continuous wear of Voxx Human Performance Technology Socks for 2 weeks Voxx Human Performance Technology Socks: 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.	Placebo Socks n=27 Participants Continuous wear of placebo socks for 2 weeks Placebo Socks: 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.
Change in Objective Measurement of Chemotherapy-induced Peripheral Neuropathy (Score on the Timed Up and Go Test)	10.19 seconds Standard Deviation 2.96	10.55 seconds Standard Deviation 3.02

SECONDARY outcome

Timeframe: 6 weeks

Impact on quality of life will be measured by the changes in scores on the Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29). PROMIS-29 is a collection of short form instruments which encompass PROMIS domains (depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social and activities) in addition to a single item assessing pain intensity. The PROMIS 29 contains 4 items per domain plus one pain intensity item, totaling 29 items. Each domain is scored separately. For all domains (besides pain intensity) the raw score lies between 4 to 20. The PROMIS-29 uses a T-score metric to score its domains, with a mean of 50 and a standard deviation of 10, where higher scores indicate better health or less of the concept being measured.

Outcome measures

Outcome measures
Measure	Voxx Human Performance Technology Socks n=28 Participants Continuous wear of Voxx Human Performance Technology Socks for 2 weeks Voxx Human Performance Technology Socks: 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.	Placebo Socks n=28 Participants Continuous wear of placebo socks for 2 weeks Placebo Socks: 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.
Change in Quality of Life Measurement Physical Function	43.19 score on a scale Standard Deviation 8.29	42.66 score on a scale Standard Deviation 8.94
Change in Quality of Life Measurement Anxiety	52.86 score on a scale Standard Deviation 9.36	52.76 score on a scale Standard Deviation 9.13
Change in Quality of Life Measurement Depression	50.04 score on a scale Standard Deviation 9.29	49.63 score on a scale Standard Deviation 8.93
Change in Quality of Life Measurement Fatigue	52.18 score on a scale Standard Deviation 9.65	53.94 score on a scale Standard Deviation 11.12
Change in Quality of Life Measurement Sleep Disturbance	57.03 score on a scale Standard Deviation 2.57	56.76 score on a scale Standard Deviation 2.67
Change in Quality of Life Measurement Pain Interference	57.75 score on a scale Standard Deviation 8.97	58.2 score on a scale Standard Deviation 8.69
Change in Quality of Life Measurement Ability to participate in social and activities	49.86 score on a scale Standard Deviation 8.78	49.11 score on a scale Standard Deviation 10.41

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Outcome measures
Measure	Voxx Human Performance Technology Socks n=28 Participants Continuous wear of Voxx Human Performance Technology Socks for 2 weeks Voxx Human Performance Technology Socks: 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.	Placebo Socks n=28 Participants Continuous wear of placebo socks for 2 weeks Placebo Socks: 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.
Change in Cancer-related Symptom Experience	26.39 score on a scale Standard Deviation 17.89	27.61 score on a scale Standard Deviation 18.1

SECONDARY outcome

Timeframe: 6 weeks

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

Outcome measures

Outcome measures
Measure	Voxx Human Performance Technology Socks n=25 Participants Continuous wear of Voxx Human Performance Technology Socks for 2 weeks Voxx Human Performance Technology Socks: 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.	Placebo Socks n=25 Participants Continuous wear of placebo socks for 2 weeks Placebo Socks: 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.
Feasibility of Voxx Socks Use	17.31615 hours/day Standard Deviation 6.463149	16.65153 hours/day Standard Deviation 6.011369

Adverse Events

Voxx Human Performance Technology Socks

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Socks

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Voxx Human Performance Technology Socks n=28 participants at risk Continuous wear of Voxx Human Performance Technology Socks for 2 weeks Voxx Human Performance Technology Socks: 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.	Placebo Socks n=28 participants at risk Continuous wear of placebo socks for 2 weeks Voxx Human Performance Technology Socks: 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.
Musculoskeletal and connective tissue disorders Pain in extremity	7.1% 2/28 • Number of events 4 • from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first)	3.6% 1/28 • Number of events 1 • from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first)
Skin and subcutaneous tissue disorders Other - Skin Iritation	3.6% 1/28 • Number of events 1 • from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first)	0.00% 0/28 • from the start of treatment until 30 days following the end of treatment or until initiation of a new anticancer therapy (whichever occurs first)

Additional Information

Dr. Arash Asher

Cedars-Sinai Medical Center

Phone: 310-423-1218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place