Chemotherapy - Induced Peripheral Neuropathy
Primary Purpose
Breast Cancer Female
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cryotherapy (frozen glove)
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer Female focused on measuring peripheral neuropathy, cryotherapy, frozen gloves
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.
Sites / Locations
- Chung Shan Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention side
Control side
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05138042
First Posted
November 1, 2021
Last Updated
November 27, 2021
Sponsor
Chung Shan Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05138042
Brief Title
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
October 7, 2019 (Actual)
Study Completion Date
October 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
peripheral neuropathy, cryotherapy, frozen gloves
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention side
Arm Type
Experimental
Arm Description
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
Arm Title
Control side
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Cryotherapy (frozen glove)
Intervention 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 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.
Primary Outcome Measure Information:
Title
peripheral neuropath (hand sensory symptoms and hand motor symptoms) "change" is being assessed.
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We have no plan to provide IPD.
Learn more about this trial
Chemotherapy - Induced Peripheral Neuropathy
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