Nail Changes Associated With Chemotherapy and Prevention of Nail Pigmentation by Ice Water Immersion

Breast Cancer Clinical Trial

— NIPPER  

Official title:

An Observational Study About Nail Changes Associated With Adjuvant/Neo-adjuvant Chemotherapy and a Prospective Phase II Study About Prevention of Chemotherapy-related Nail Pigmentation by Ice Water Immersion in Breast Cancer Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04215744
• Other study ID #: SYSU003-2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2020
• Est. completion date: December 2022

Study information

• Verified date: February 2020
• Source: Sun Yat-sen University
• Contact: Fei Xu, MD
• Phone: +86-13711277870
• Email: xufei[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Anthracyclines combined with cyclophosphamide or taxane-containing regimens may cause nail pigmentation which reduces quality of life in breast cancer patients. We conducted this study to investigate nail pigmentation and other skin changes associated with these drugs and aim to evaluate the effect of ice water immersion of hands on nail pigmentation. The first phase is an observational study. Breast cancer patients who received anthracyclines combined with cyclophosphamide or taxane-containing regimens for adjuvant/neoadjuvant chemotherapy are enrolled. The second phase is a prospective phase II study. Early breast cancer patients who plan to receive these drugs for adjuvant/neoadjuvant chemotherapy are treated with ice water immersion of the left hands while their right hands serve as control. The primary end point is the degree of nail pigmentation. The other end points are the incidence of nail pigmentation in both hands, the degree and the incidence of onycholysis, the time from the first chemotherapy to the occurrence of nail pigmentation/onycholysis, the recovery of nail pigmentation/onycholysis, and patient comfort.

Description:

Anthracyclines combined with cyclophosphamide or taxane-containing regimens are commonly used for adjuvant or neoadjuvant chemotherapy in breast cancer patients. However, these drugs may cause nail pigmentation which reduces quality of life in patients. We conducted this study to investigate nail pigmentation and other skin changes associated with anthracyclines in combination with cyclophosphamide or taxane-containing regimens in breast cancer patients who received adjuvant or neoadjuvant chemotherapy. Besides, we aim to evaluate the effect of ice water immersion of hands on nail pigmentation caused by chemotherapy.

The first phase is an observational study. Breast cancer patients who received anthracyclines combined with cyclophosphamide or taxane-containing regimens for adjuvant or neoadjuvant chemotherapy were followed up until six months after the last course of chemotherapy. The second phase is a prospective phase II study. Early breast cancer patients who plan to receive anthracyclines combined with cyclophosphamide or taxane-containing regimens for adjuvant or neoadjuvant chemotherapy are treated with ice water immersion of the left hands while their right hands serve as control. The primary end point is the degree of nail pigmentation. The other end points are the incidence of nail pigmentation in both hands, the degree and the incidence of onycholysis, the time from the first chemotherapy to the occurrence of nail pigmentation/onycholysis, the recovery of nail pigmentation/onycholysis, and patient comfort.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Early breast cancer patients who plan to receive anthracyclines combined with cyclophosphamide or taxane-containing regimens for adjuvant/neoadjuvant chemotherapy

• No previous nail or skin abnormalities

• No upper limb defects

• Have not received any antitumor treatments before

Exclusion Criteria:

• Have any mental condition that prevents the understanding of the contents of this study and can't complete the study or provide the information required.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Ice water immersion
Ice water immersion of the left hands

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient comfort	Patients' comfort level is assessed using a 4-point rating system that determined whether patients were dissatisfied (0), not very satisfied (1), satisfied (2), or very satisfied (3)	1 year
Other	Occurrence time of nail pigmentation/onycholysis	Defined as the time from the first chemotherapy to the occurrence of nail pigmentation/onycholysis.	1 year
Other	Recovery time of nail pigmentation/onycholysis	Defined as the time from the occurrence to the recovery of nail pigmentation/onycholysis.	1 year
Primary	Degree of nail pigmentation	Score according to the area of the nail bed where the pigmentation occurs and the color depth: Area score: 0 (no change), 1 (1/3 area of nail bed), 2 (2/3 area), 3 (3/3 area); Color score: 0 (no change), 1 (light), 2 (gray), 3 (black). The most severe finger is selected to score.	1 year
Secondary	Degree of onycholysis	According to National Cancer Institute Common Toxicity Criteria; that is, grade 1, indicated by discoloration, ridging (koilonychia), or pitting; and grade 2, indicated by partial or complete onycholysis or pain in the nail bed.	1 year
Secondary	Incidence of nail pigmentation	As long as one finger has nail pigmentation, it is regarded that one patient has nail pigmentation.	1 year
Secondary	Incidence of onycholysis	As long as one finger has onycholysis, it is regarded that one patient has onycholysis.	1 year