Heart and Blood Diseases

All Conditions

Symptoms and General Pathology

Substance Related Disorders

Wounds and Injuries

Rare Diseases

Heart Failure

Cardiomyopathies

Arrhythmias, Cardiac

Cardiotoxicity

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Radiation Injuries

Doxorubicin Induced Cardiomyopathy

Antineoplastic Agents

All Drugs and Chemicals

Doxorubicin

Liposomal doxorubicin

Medication: Once per day on an empty stomach in the morning. Treatment cycle: 3 days before the first administration of doxorubicin to the entire treatment cycle of doxorubicin.

Dosage: DH001 placebo (8 tablets)

Medication: once per day on an empty stomach in the morning. Treatment cycle: 3 days before the first administration of doxorubicin to the entire treatment cycle of doxorubicin.

Dosage: DH001 200mg (4 tablets) + DH001 placebo (4 tablets)

Medication: Once per day on an empty stomach in the morning. Treatment cycle: 3 days before the first administration of doxorubicin to the entire treatment cycle of doxorubicin.

Dosage: DH001 400mg (8 tablets).

Control group:DH001 placebo

Dosage: DH001 200mg (4 tablets) + DH001 placebo (4 tablets)

Trial group: DH001 low-dose group

Trial group: DH001 high-dose group

Jun Ma

Jun Zhu

Hongmei Jing

Hui Zhou

Yufu Li

Hesheng He

Zeping Zhou

Wenbin Qian

Xiaojia Wang

Jiwei Liu

Zhenchang Sun

Purpose：1. Preliminary evaluation of the preventive effect of DH001 on doxorubicin-induced cardiotoxicity in cancer patients 2.To explore appropriate dosages to provide basis for dosages in subsequent confirmatory studies 3.To evaluate the effect of DH001 on the efficacy of doxorubicin treatment in cancer patients 4.To evaluate the safety of DH001 in cancer patients treated with doxorubicin

After the subjects sign the informed consent form, meet the inclusion criteria and do not meet the exclusion criteria, they will receive a random number according to the order of enrollment, and will be randomly assigned to the DH001 low-dose group (200 mg), DH001 high-dose group (400 mg) and control group in a 1:1:1 manner according to the randomization plan；Stratification factor: Patient's tumor type \[lymphoma and non-lymphoma (breast cancer, soft tissue sarcoma, etc.)\].

A Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients

The incidence of cardiac events in subjects during doxorubicin treatment

Monyan Pharmaceutical (Shanghai) Co., Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients	NCT06092606	Cancer Heart Failure Arrhythmia Doxorubicin Ind... Doxorubicin Adv...	Control group:D... Trial group: DH... Trial group: DH...	18 Years - 75 Years	Monyan Pharmaceutical (Shanghai) Co., Ltd.
A Multicenter Clinical Trial on DH001 Tablets in the Prevention of Doxorubicin-induced Cardiotoxicity in Cancer Patients	NCT06092606	Cancer Heart Failure Arrhythmia Doxorubicin Ind... Doxorubicin Adv...	Control group:D... Trial group: DH... Trial group: DH...	18 Years - 75 Years	Monyan Pharmaceutical (Shanghai) Co., Ltd.

Spots Global Cancer Trial Database for control group:dh001 placebo