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

NCT04215744 | Unknown

• 1 other identifier: SYSU003-2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (3)

• Degree of onycholysis

  1 year

• Incidence of nail pigmentation

  1 year

• Incidence of onycholysis

  1 year

Other Outcomes (3)

• Patient comfort

  1 year

• Occurrence time of nail pigmentation/onycholysis

  1 year

• Recovery time of nail pigmentation/onycholysis

  1 year

Study Arms (2)

Ice water immersion group

EXPERIMENTAL

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

Control group

NO INTERVENTION

No intervention of the right hands as control.

Interventions

Ice water immersion BEHAVIORAL

Ice water immersion of the left hands

Ice water immersion group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fei Xu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fei Xu, MD

CONTACT

+86-13711277870; xufei@sysucc.org.cn

Kuikui Jiang, MD

CONTACT

+86-15210589011; jiangkk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: self-control study

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: February 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)