NIPPER: Nail Changes Associated With Chemotherapy and Prevention of Nail Pigmentation by Ice Water Immersion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ice water immersion group Ice water immersion of the left hands(30 minutes before the infusion, during the infusion, and 30 minutes after the end of infusion). |
Behavioral: Ice water immersion
Ice water immersion of the left hands
|
| No Intervention: Control group No intervention of the right hands as control. |
Outcome Measures
Primary Outcome Measures
- 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
- 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 Outcome Measures
- 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)
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Early breast cancer patients who plan to receive anthracyclines combined with cyclophosphamide or taxane-containing regimens for adjuvant/neoadjuvant chemotherapy
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No previous nail or skin abnormalities
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No upper limb defects
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Fei Xu, MD, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SYSU003-2020