Trial Outcomes & Findings for Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients (NCT NCT04256512)

NCT ID: NCT04256512

Last Updated: 2025-07-28

Results Overview

Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 94 participants
• Primary outcome timeframe: During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up
• Results posted on: 2025-07-28

Participant Flow

This single arm non-randomized study was conducted at Mayo Clinic in Florida. Participants included early breast cancer patients who underwent standard of care chemotherapy and who had Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no sensory peripheral neuropathy at study entry. Patients with metastatic breast cancer, Raynaud's and peripheral vascular disease, cryoglobulinemia, cold intolerance, prior exposure to neurotoxic or taxane chemotherapy were excluded.

Participant milestones

Measure	Prevention (Elasto Gel Therapy Mittens and Foot Wraps) Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment. Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps Questionnaire Administration: Ancillary studies
Overall Study STARTED	94
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Prevention (Elasto Gel Therapy Mittens and Foot Wraps) Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment. Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps Questionnaire Administration: Ancillary studies

Overall Study Withdrawal by Subject

1

Baseline Characteristics

Cryotherapy for the Prevention of Taxane-Induced Sensory Neuropathy of the Hands and Feet in Breast Cancer Patients

Baseline characteristics by cohort

Measure	Prevention (Elasto Gel Therapy Mittens and Foot Wraps) n=94 Participants Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment. Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps Questionnaire Administration: Ancillary studies
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	80 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants
Age, Continuous	54 years STANDARD_DEVIATION 12.270 • n=5 Participants
Sex: Female, Male Female	94 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	22 Participants n=5 Participants
Race/Ethnicity, Customized White	62 Participants n=5 Participants
Race/Ethnicity, Customized Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	94 participants n=5 Participants

PRIMARY outcome

Timeframe: During chemotherapy (baseline), after chemotherapy (1 week post baseline), at 3 month follow up

Population: Adults ages 18 and older with diagnosis of breast cancer undergoing 3 months of taxane based chemotherapy \[4 cycles of weekly paclitaxel (1 cycle = 3 weeks) or docetaxel every 3 weeks x 4-6 cycles\].

Number of subjects to experience chemotherapy induced peripheral neuropathy (CIPN).

Outcome measures

Measure	Prevention (Elasto Gel Therapy Mittens and Foot Wraps) n=93 Participants Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment. Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps Questionnaire Administration: Ancillary studies
Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) During chemotherapy	41 Participants
Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) After chemotherapy	30 Participants
Incidence of Chemotherapy Induced Peripheral Neuropathy (CIPN) 3 month follow up	25 Participants

Adverse Events

Prevention (Elasto Gel Therapy Mittens and Foot Wraps)

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Prevention (Elasto Gel Therapy Mittens and Foot Wraps) n=93 participants at risk Patients wear Elasto Gel Therapy Mittens and Foot Wraps on both hands and feet 15 minutes prior to each infusion, during the entire infusion, and for 15 minutes after the completion of each infusion during their three months of treatment. Medical Device Usage and Evaluation: Wear Elasto Gel Therapy Mittens and Foot Wraps Questionnaire Administration: Ancillary studies
Nervous system disorders Neuropathy during chemotherapy (Grade 1)	44.1% 41/93 • Number of events 41 • Adverse event (AE) data were collected prior to each cycle of chemo, at the end of each cycle, and 3 months after chemotherapy. Patients were evaluated for chemotherapy induced peripheral neuropathy (CIPN).
Nervous system disorders Neuropathy after chemotherapy (Grade 1)	34.1% 28/82 • Number of events 28 • Adverse event (AE) data were collected prior to each cycle of chemo, at the end of each cycle, and 3 months after chemotherapy. Patients were evaluated for chemotherapy induced peripheral neuropathy (CIPN).
Nervous system disorders Neuropathy after chemotherapy (Grade 2)	2.4% 2/82 • Number of events 2 • Adverse event (AE) data were collected prior to each cycle of chemo, at the end of each cycle, and 3 months after chemotherapy. Patients were evaluated for chemotherapy induced peripheral neuropathy (CIPN).
Nervous system disorders Neuropathy at 3 month follow up (Grade 1)	23.8% 19/80 • Number of events 19 • Adverse event (AE) data were collected prior to each cycle of chemo, at the end of each cycle, and 3 months after chemotherapy. Patients were evaluated for chemotherapy induced peripheral neuropathy (CIPN).
Nervous system disorders Neuropathy at 3 month follow up (Grade 2)	7.5% 6/80 • Number of events 6 • Adverse event (AE) data were collected prior to each cycle of chemo, at the end of each cycle, and 3 months after chemotherapy. Patients were evaluated for chemotherapy induced peripheral neuropathy (CIPN).

Additional Information

Pooja P. Advani, MBBS

Mayo Clinic

Phone: 904-953-7291

Email: Advani.Pooja@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place