Corticosteroids for Doxorubicin Liposome-Induced Hand-Foot-Skin Reactions
China182 participantsStarted 2025-03-07
Plain-language summary
Investigating the Association Between Corticosteroid Use and Improvement in Doxorubicin Liposome-Induced Cutaneous Toxicity: Exploring the Feasibility and Mechanisms of Corticosteroids in Mitigating Liposomal Doxorubicin-Related Dermatologic Adverse Effects.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients aged 18-70 years (inclusive), regardless of gender.
✓. Diagnosis \& Treatment Plan: Histopathologically confirmed early-stage or advanced breast cancer patients eligible for AC regimen (liposomal doxorubicin + cyclophosphamide) chemotherapy per clinical guidelines.
✓. ECOG Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
✓. Anticipated survival ≥3 months.
✓. Organ Function Requirements:
✓. Contraception:
✓. Informed Consent: Patients must voluntarily participate, provide signed informed consent, and comply with protocol-specified procedures (blood tests, follow-ups, etc.).
Exclusion criteria
✕. Received chemotherapy, radiotherapy, biologics, targeted therapy, immunotherapy, or other antitumor treatments within 4 weeks before the first study dose (or within 5 half-lives, whichever is shorter). Exceptions: The washout period may be adjusted per investigator judgment (e.g., shortened to 2 weeks for endocrine therapy to avoid prolonged patient waiting).
✕. Previous treatment with liposomal doxorubicin or similar formulations.
✕. Allergy History: Known hypersensitivity to liposomal products or doxorubicin.
✕. Cardiovascular Diseases:
What they're measuring
1
Number of participants with hand-foot syndrome (HFS) as assessed by CTCAE v5.0 in the high-dose dexamethasone group
. Active Infections: Grade ≥2 （NCI CTCAE v5.0）
✕. Immunosuppression:
✕. HBsAg-positive with HBV-DNA ≥500 IU/mL. Exception: If HBV-DNA \<500 IU/mL and chronic hepatitis is deemed stable/inactive by the investigator, enrollment is permitted.
✕. Other Infections: Positive for HCV antibody or syphilis-specific antibody.