Clinical trial · Interventional
Nail Changes Associated With Chemotherapy and Prevention of Nail Pigmentation by Ice Water Immersion
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ice water immersion | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ice water immersion group
- description
- Ice water immersion of the left hands(30 minutes before the infusion, during the infusion, and 30 minutes after the end of infusion).
- interventionNames
- Behavioral: Ice water immersion
- type
- NO_INTERVENTION
- label
- Control group
- description
- No intervention of the right hands as control.
Primary outcomes (1)
- measure
- Degree of nail pigmentation
- timeFrame
- 1 year
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available