The Effect of Cryotherapy on Breast Cancer Patients

NCT06020222 | Unknown

• 2 other identifiers: KMUHIRB-F(I)-20230041TWNA-1121020
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

breast cancer; chemotherapy; neuropathy; cryotherapy

Outcome Measures

Primary Outcomes (5)

• Patient neurotoxicity questionnaire (PNQ)

  the incidence of sensory and motor neuropathy, the Grade A to E, the higher the grade, the more serious

  first day

• Patient neurotoxicity questionnaire (PNQ)

  the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious

  the day after the first chemotherapy

• Patient neurotoxicity questionnaire (PNQ)

  the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious

  the day after the second chemotherapy

• Patient neurotoxicity questionnaire (PNQ)

  the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious

  the day after the third chemotherapy

• Patient neurotoxicity questionnaire (PNQ)

  the incidence of sensory and motor neuropathy,the Grade A to E, the higher the grade, the more serious

  the day after the fourth chemotherapy

Secondary Outcomes (15)

• European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20

  first day

• European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20

  the day after the first chemotherapy

• European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20

  the day after the second chemotherapy

• European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20

  the day after the third chemotherapy

• European Organization for Research and Treatment of Cancer quality of life questionnaire-chemotherapy-induced peripheral neuropathy 20

  the day after the fourth chemotherapy

Other Outcomes (4)

• the adverse event and discomfort

  the day after the first cryotherapy

• the adverse event and discomfort

  the day after the second cryotherapy

• the adverse event and discomfort

  the day after the third cryotherapy

Study Arms (2)

Cryotherapy group

EXPERIMENTAL

Both hands and feet received cryotherapy gloves and boots

Device: cryotherapy

Usual care group

PLACEBO COMPARATOR

health education leaflets

Other: education

Interventions

cryotherapy 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.

Cryotherapy group

education OTHER

Provide preventive CIPN education leaflets

Usual care group

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead
• Taiwan Nurses Association: collaborator

Study Sites (1)

Tsai-Rung Lin

Kaohsiung City, Taiwan

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryotherapy; Educational Status

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Socioeconomic Factors; Population Characteristics

Study Officials

• Tsai-Rung Lin, Master

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsai-Rung Lin, Master

CONTACT

07-31211014; 920410@kmuh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Assessors don't know groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: August 31, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 31, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)