Chemotherapy - Induced Peripheral Neuropathy

NCT05138042 | Completed

• 1 other identifier: CS2-19004
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to examine the efficacy of cryotherapy with frozen gloves for the prevention of the chemotherapy-induced peripheral neuropathy (CIPN) of the hand. Frozen glove was provided for dominant hand of breast cancer patients while receiving paclitaxel treat, and as the experimental group. In addition, another hand as a control group. The questionnaire was used before chemotherapy and at the fourth, eighth, twelfth, and sixteenth weeks to understand the effectiveness of frozen gloves.

Conditions

Breast Cancer Female

Keywords

peripheral neuropathy; cryotherapy; frozen gloves

Outcome Measures

Primary Outcomes (1)

• peripheral neuropath (hand sensory symptoms and hand motor symptoms) "change" is being assessed.

  The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 (EORTC QLQ-CIPN 20) was used to assess chemotherapy-induced peripheral neuropathy in breast cancer patients. It contains 20 items and includes three scales (sensory scale, motor scale, and autonomic scale) In this study, we focused on the evaluation of the peripheral neurological symptoms of the hand according to the purpose of the research. Therefore, we selected the scope related to the hand in the EORTC QLQ-CIPN20 as an assessment item. It contains four items about sensory symptoms and four items about motor symptoms.Each item is rated on a 4-point Likert-type scale ranging from 1 (not at all) to 4 (very much). The total score is the sum of all item scores. Higher scores reflect more peripheral neuropathic signs and symptoms.

  Questionnaire were filled out five times, before the first chemotherapy session and at the fourth, eighth, twelfth, and sixteenth weeks following the first chemotherapy session.

Study Arms (2)

Intervention side

EXPERIMENTAL

Breast cancer patients wore frozen glove on the dominant hand for 90 minutes during their weekly treatment with paclitaxel (80 mg/m2). Treatment was continued for 12 weeks, with their non-dominant hand as the control side

Other: Cryotherapy (frozen glove)

Control side

NO INTERVENTION

Breast cancer patients wore frozen glove on the dominant hand for 90 minutes during their weekly treatment with paclitaxel (80 mg/m2). Treatment was continued for 12 weeks, with their non-dominant hand as the control side

Interventions

Cryotherapy (frozen glove) OTHER

In this study, the cryotherapy interventions were based on previous studies, with the dominant hand wearing the frozen glove set as the experimental group, and the non-dominant hand that was not wearing a frozen glove as the control group. The cold temperature of the refrigerator was measured in advance to be -20.2°C to -22.8°C. The freezing of the gloves lasted for at least three hours, and the gloves were tested with an infrared temperature-measuring instrument before use. Its temperature range was -24.3°C to -24.7°C. The patient began to wear gloves 15 minutes before the administration of paclitaxel for one hour, and replaced them with new frozen gloves at the 45th minute. The patient continued to wear the gloves until 15 minutes after the end of the chemotherapy drug administration, for a total of 90 minutes.

Intervention side

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with breast cancer diagnosis confirmed by a physician and receiving paclitaxel for the first time.
• Above 20 years of age.

You may not qualify if:

• Patients with neurological disease histories.
• Patients with histories of the hand-foot syndrome.
• Patients with distant cancer metastases or skin metastases.
• Patients with nail lesions or the absence of fingers.
• Patients with a low tolerance to cold, and edema.

Sponsors & Collaborators

• Chung Shan Medical University: lead

Study Sites (1)

Chung Shan Medical University

Taichung, 40201, Taiwan

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Frozen glove was provided for dominant hand of breast cancer patients while receiving paclitaxel treat, and as the experimental group. In addition, another hand as a control group.

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 30, 2021
• Study Start: October 1, 2019
• Primary Completion: October 7, 2019
• Study Completion: October 15, 2020
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)