Nail Changes Associated With Chemotherapy and Prevention of Nail Pigmentation by Ice Water Immersion (NIPPER)
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ice water immersion
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Ice water immersion group
Control group
Arm Description
Ice water immersion of the left hands(30 minutes before the infusion, during the infusion, and 30 minutes after the end of infusion).
No intervention of the right hands as control.
Outcomes
Primary Outcome Measures
Degree of nail pigmentation
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
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
As long as one finger has nail pigmentation, it is regarded that one patient has nail pigmentation.
Incidence of onycholysis
As long as one finger has onycholysis, it is regarded that one patient has onycholysis.
Full Information
NCT ID
NCT04215744
First Posted
December 30, 2019
Last Updated
February 1, 2020
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04215744
Brief Title
Nail Changes Associated With Chemotherapy and Prevention of Nail Pigmentation by Ice Water Immersion
Acronym
NIPPER
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
self-control study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ice water immersion group
Arm Type
Experimental
Arm Description
Ice water immersion of the left hands(30 minutes before the infusion, during the infusion, and 30 minutes after the end of infusion).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention of the right hands as control.
Intervention Type
Behavioral
Intervention Name(s)
Ice water immersion
Intervention Description
Ice water immersion of the left hands
Primary Outcome Measure Information:
Title
Degree of nail pigmentation
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Degree of onycholysis
Description
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.
Time Frame
1 year
Title
Incidence of nail pigmentation
Description
As long as one finger has nail pigmentation, it is regarded that one patient has nail pigmentation.
Time Frame
1 year
Title
Incidence of onycholysis
Description
As long as one finger has onycholysis, it is regarded that one patient has onycholysis.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Patient comfort
Description
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)
Time Frame
1 year
Title
Occurrence time of nail pigmentation/onycholysis
Description
Defined as the time from the first chemotherapy to the occurrence of nail pigmentation/onycholysis.
Time Frame
1 year
Title
Recovery time of nail pigmentation/onycholysis
Description
Defined as the time from the occurrence to the recovery of nail pigmentation/onycholysis.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Xu, MD
Phone
+86-13711277870
Email
xufei@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Kuikui Jiang, MD
Phone
+86-15210589011
Email
jiangkk@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Xu, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nail Changes Associated With Chemotherapy and Prevention of Nail Pigmentation by Ice Water Immersion
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