An interventional study of Cryotherapy (frozen glove) in Breast Cancer Female, sponsored by Chung Shan Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Supportive care
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.
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.
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This study's enrollment of 22 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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)
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
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.
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.
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.
Plan to share: No — We have no plan to provide IPD.
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Chung Shan Medical University