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

Not Applicable

• Conditions: Breast Cancer
• Interventions: Behavioral: Ice water immersion

• Registration Number: NCT04215744
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2019-12-30
• Study First Posted: 2020-01-02
• Status Verified: 2020-02
• Study Start: 2020-02
• Last Update Submitted: 2020-02-01
• Last Update Posted: 2020-02-05
• Primary Completion: 2021-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ice water immersion group	Ice water immersion	Ice water immersion of the left hands(30 minutes before the infusion, during the infusion, and 30 minutes after the end of infusion).

Primary Outcome Measures

Name	Time	Method
Degree of nail pigmentation	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Degree of onycholysis	1 year	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.
Incidence of nail pigmentation	1 year	As long as one finger has nail pigmentation, it is regarded that one patient has nail pigmentation.
Incidence of onycholysis	1 year	As long as one finger has onycholysis, it is regarded that one patient has onycholysis.

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China