Breast Cancer Clinical Trial
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
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.
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.
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