Breast Cancer
Conditions
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.
Interventions
BEHAVIORALIce water immersion
Ice water immersion of the left hands
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
self-control study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Occurrence time of nail pigmentation/onycholysis | 1 year | Defined as the time from the first chemotherapy to the occurrence of nail pigmentation/onycholysis. |
| Recovery time of nail pigmentation/onycholysis | 1 year | Defined as the time from the occurrence to the recovery of nail pigmentation/onycholysis. |
| Patient comfort | 1 year | 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) |
Countries
China
Contacts
Primary ContactFei Xu, MD
Backup ContactKuikui Jiang, MD
Outcome results
None listed