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The Effect of Cryotherapy on Breast Cancer Patients

NCT ID: NCT06020222

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-12-31

Brief Summary

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The goal of this clinical trial is to test the effect of cryotherpay on chemotherapy-induced peripheral neuropathy(CIPN) among Breast Cancer Patients. The main questions of research are:

* Does cryotherapy reduce the incidence of CIPN?
* Does cryotherapy reduce the severity of CIPN and improve the quality of life? Participants will be put on the cold gloves and boots during chemotherapy injection process and total 90 minutes.

If there is a comparison group: Researchers will compare usual care group to make sure if it effects of CIPN.

Detailed Description

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This study is designed as a experiment study. In a medical center and breast ward, a randomized controlled trial was used to evaluate the effect of cryotherapy. Block sampling was adopted, and participants total 94 were included. Patients were randomly assigned to the croytherapy group (n=47) or the usual care group(n=47). Both hands and feet received cryotherapy, and the frequency was once every three weeks. Each cycle was 90-150 minutes, and the cycle was performed 4-8 times. The instrument included EPRTC QLQ-CIPN20, PNQ, and EORTC QLQ-C30. After 12-32 weeks, the cryotherapy received qualitative interviews to collect experience and perceptions. Quantitaitve data were constructed and analyzed with SPSS 20.0 version, and Chi-square test was used to detect the incidence of CIPN after three months. Mixed linear model was used to detect the severity of peripheral neuropathy symptoms and quality of life. Survival analysis was used to compare the occurrence time of peripheral neuropathy events between groups.

Conditions

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Chemotherapy-induced Peripheral Neuropathy

Keywords

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breast cancer chemotherapy neuropathy cryotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
Assessors don't know groups

Study Groups

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Cryotherapy group

Both hands and feet received cryotherapy gloves and boots

Group Type EXPERIMENTAL

cryotherapy

Intervention Type DEVICE

Both hands and feet received cryotherapy gloves and boots, and the frequency was once every three weeks. Each cycle was 90 minutes, and the cycle was performed 4 times.

Usual care group

health education leaflets

Group Type PLACEBO_COMPARATOR

education

Intervention Type OTHER

Provide preventive CIPN education leaflets

Interventions

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cryotherapy

Both hands and feet received cryotherapy gloves and boots, and the frequency was once every three weeks. Each cycle was 90 minutes, and the cycle was performed 4 times.

Intervention Type DEVICE

education

Provide preventive CIPN education leaflets

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Breast cancer stage I-III, first time receive paclitaxel neurotoxic chemotherapy, consciousness clear, able to communicate in Taiwanese or Mandarin

Exclusion Criteria

* Insulin depent diabetes, Raynaud's disease, cold urticaria disease, cryoglobulinemia and sclerosing basal cell carcinoma, those diagnosed with mental illness, and those with visual or hearing impairments.
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Taiwan Nurses Association

OTHER

Sponsor Role collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tsai-Rung Lin, Master

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

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Tsai-Rung Lin

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tsai-Rung Lin, Master

Role: CONTACT

Phone: 07-31211014

Email: [email protected]

Facility Contacts

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Tsai Rung Lin, Master

Role: primary

Other Identifiers

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TWNA-1121020

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

KMUHIRB-F(I)-20230041

Identifier Type: -

Identifier Source: org_study_id