Trials
Search / Trial NCT06441513

The Preventive Effect of Chemotherapy-induced Hand-foot Syndrome

Launched by PEKING UNIVERSITY THIRD HOSPITAL · May 29, 2024

Trial Information

Current as of February 12, 2025

Recruiting

Keywords

Hand Foot Syndrome Case Tracking Management Tcm External Treatment Nursing

ClinConnect Summary

This clinical trial is investigating a new way to prevent hand-foot syndrome (HFS), a painful condition that can occur after chemotherapy for cancer patients. The study will use a traditional Chinese medicine bath that is known to have no major side effects, along with a special management plan to help patients avoid developing HFS. Researchers at Peking University Third Hospital are looking for participants who are currently undergoing chemotherapy and do not already have symptoms of HFS.

To be eligible, participants should be between the ages of 18 and 65, expect to live at least three more months, and have normal functioning of their major organs. They should also be able to understand the study and provide consent. If you join the trial, you can expect to receive the traditional Chinese medicine treatment and management support while the researchers track your symptoms closely. This study is currently recruiting participants, and your involvement could help improve care for others undergoing similar treatments in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • (1) no HFS symptoms in chemotherapy patients; (2) Ages 18 to 65 years; (3) Estimated survival ≥ 3 months; (4) There was no dysfunction of major organs, heart, liver and kidney functions were basically normal, and the laboratory indicators met the following requirements: neutrophils \> 1.5 × 109/l, platelets \> 100 × 109/l, hemoglobin \> 90g/l; Bilirubin was normal or \< 1.5 × ULN; AST and alt \< 2.5 × ULN; Serum creatinine \< 1.5 × ULN; Endogenous creatinine clearance (CCR) ≥ 60ml/min. (5) Those who can understand the situation of this study, can cooperate in the assessment of HFS grading, and have signed the informed consent.
  • Exclusion Criteria:
  • (1) history of nerve trauma before chemotherapy, diabetic neuropathy, spinal cord compression syndrome without surgical treatment, spinal canal stenosis or spinal cord nerve root compression, and central nervous system tumors; (2) Patients with skin lesions of hands and feet; (3) Those who have plans to use other drugs that may affect HFS (including urea cream, vitamin B6, celecoxib, compound Sophora flavescens injection, calf blood deproteinized extract intravenous injection); (4) Patients with severe, uncontrolled organic lesions or infections, such as decompensated heart, lung, renal failure, etc., that lead to intolerance to chemotherapy; (5) Those who participate in other clinical trials at present or within 4 weeks; (6) Obvious neurological and psychiatric history, including dementia or epilepsy that may affect understanding and informed consent; (7) Intolerant or allergic to the traditional Chinese medicine prescriptions in this study.

Trial Officials

Yamei Chen

Study Chair

Peking University Third Hospital Library

About Peking University Third Hospital

Peking University Third Hospital is a leading medical institution in China, renowned for its commitment to advanced healthcare, innovative research, and comprehensive clinical services. As a prominent sponsor of clinical trials, the hospital emphasizes the integration of cutting-edge scientific research with patient-centered care to enhance therapeutic outcomes. With a multidisciplinary approach, the institution fosters collaboration among top-tier medical professionals and researchers, striving to contribute to the global medical community through rigorous clinical studies that address pressing health challenges. Its dedication to ethical standards and regulatory compliance ensures the safety and efficacy of new treatments, ultimately aiming to improve patient care and outcomes on both a national and international scale.

Locations

Beijing, Beijing, China

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0