Clinical trial NCT05138042: Chemotherapy - Induced Peripheral Neuropathy
Official title: Effect of Cryotherapy on Paclitaxel-Induced Peripheral Neuropathy of the Hand in Female Breast Cancer Patients: A Prospective Self-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: peripheral neuropathy
cryotherapy
frozen gloves
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2021-11-30
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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 Elasto-Gel flexible frozen glove (Southwest Technologies, North Kansas City, MO, USA) used in this study lasted for 20 to 40 minutes and was easy to clean.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. These intervention procedures were used for each treatment for 12 weeks.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: peripheral neuropath (hand sensory symptoms and hand motor symptoms) "change" is being assessed.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University
Study officials:
References: