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

NCT04215744 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-02-05

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Ice water immersion

Ice water immersion of the left hands

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Fei Xu, MD · Sun Yat-sen University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-29
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04215744 on ClinicalTrials.gov