The Effect of Cryotherapy on Breast Cancer Patients

Kaohsiung Medical University

Status: Enrolling

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Other: education; Device: cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06020222

KMUHIRB-F(I)-20230041

TWNA-1121020 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 94 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups, including a placebo group

Cryotherapy group

Experimental group

Description:

Both hands and feet received cryotherapy gloves and boots

Treatment:

Device: cryotherapy

Usual care group

Placebo Comparator group

Description:

health education leaflets

Treatment:

Other: education