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An open label, single arm study for treatment of cutaneous toxicity induced by anti-cancer therapies

An open label, single arm study of nitroglycerin ointment for treatment of cutaneous toxicity induced by anti-cancer therapies

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038321
Enrollment
Unknown
Registered
2020-09-17
Start date
2019-09-01
Completion date
Unknown
Last updated
2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous toxicity of anti-cancer therapies

Interventions

trial group:nitroglycerin

Sponsors

Shanghai Jiao Tong University School of Biomedical Engineering
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The patients voluntarily participated in the study and signed the informed consent form; 2. Patients >= 18 years old. 3. The patient was diagnosed as malignant tumor and was receiving anti-tumor drug treatment. 4. Patients with skin rash and / or hand foot syndrome related to anti-tumor drugs, with skin symptom score of 1 or above according to NCI CTCAE V5.0. 5. Patients can use external medication, and can complete the questionnaire survey. 6. Patients with ECoG score <= 2.

Exclusion criteria

Exclusion criteria: 1. The patient had skin adverse reactions (rash and / or hand foot syndrome) caused by non antineoplastic drugs before enrollment, and did not fully recover at 4 weeks before baseline. 2. Other topical drugs are being used in the corresponding parts of the patient's skin, and can not be stopped 7 days before the baseline. 3. The patient is suffering from other uncontrollable diseases, including but not limited to persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, uncontrolled hypertension or hypotension, arrhythmia or psychosis, and other social conditions that may limit patient compliance with study requirements. 4. The patient had contraindications for the use of active ingredients of the trial drug, including severe anemia, elevated intracranial pressure, and known grade III hypertension. 5. The patient has other skin diseases that may affect the assessment. 6. The patient had used phosphodiesterase-5 inhibitors such as sildenafil, vardenafil, tadalafil, etc. within 7 days before baseline. 7. The patient had obvious laboratory abnormalities. 8. The patients were pregnant or lactating women. 9. The patient is a woman with fertility possibility and is not willing to take effective contraception two weeks before and during the trial.

Design outcomes

Primary

MeasureTime frame
NCI CTCAEv5.0;

Secondary

MeasureTime frame
VAS-pain;DLQI;HF-QoL;

Countries

China

Contacts

Public ContactLina Tang

Shanghai Sixth People's Hospital

tina_8042@hotmail.com+86 18930172910

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026