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Corticosteroids for Doxorubicin Liposome-Induced Hand-Foot-Skin Reactions

NCT07362914 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-01-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Dexamethasone (12mg d1)

dexamethasone 12mg d1, PO/IV;

DRUG

Dexamethasone (2mg QD, d1-5,)

dexamethasone 12mg QD, d1-5, PO/IV.

DRUG

Doxorubicin hydrochloride liposome injection

Liposomal doxorubicin at a dose of 35 mg/m², given via intravenous (IV) infusion every 2 weeks (q2w) or every 3 weeks (q3w).

DRUG

Cyclophosphamide

Cyclophosphamide 600 mg/m² administered by intravenous infusion every 2 weeks (q2w) or every 3 weeks (q3w).

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-07
Primary Completion
2026-07-30
Completion
2027-01-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07362914 on ClinicalTrials.gov