Not Yet RecruitingNot Applicable

Traditional Chinese Medicine Hand-Foot Soak for Chemotherapy-Induced Peripheral Neuropathy and Hand-Foot Syndrome

300 participantsStarted 2026-02-01

Plain-language summary

Systemic therapies, including chemotherapy, targeted therapy, and immunotherapy, are cornerstones of modern oncology and have significantly extended patient survival. However, these treatments are frequently associated with adverse reactions that can impair patients' quality of life. Among the most common and debilitating are chemotherapy-induced peripheral neuropathy (CIPN) and hand-foot syndrome (HFS). Currently, no universally effective standard of care exists for either CIPN or HFS. Interventions such as duloxetine for CIPN or empirical vitamin use for HFS offer limited efficacy and are not robustly supported by evidence. This unmet clinical need has driven interest in complementary approaches. In recent years, traditional Chinese medicine (TCM) has been rigorously evaluated in high-quality clinical trials for various conditions, showing benefits in cardiovascular disease and oncology. However, while some studies have explored systemic TCM for preventing CIPN, research on topical TCM therapies for established CIPN and HFS is scarce. We therefore conducted this retrospective study to investigate the efficacy and safety of a topical TCM hand-foot soak for these conditions, using patient-reported outcome measures to assess its impact on symptoms and quality of life.

Who can participate

Age range18 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: * (1) The patient is over 18 years old, with no gender restrictions; (2) Pathology confirmed malignant tumor, including digestive tract tumor, lung cancer, breast cancer, etc; (3) Received systemic anti-tumor treatment, including chemotherapy, targeted therapy, etc; (4) Combination of HFS or CIPN after anti-tumor treatment; (5) After the occurrence of HFS or CIPN, according to the diagnosis and treatment routine or the patient's wishes, traditional Chinese medicine topical treatment is used, or western medicine such as methylcobalamin/vitamin B is taken orally, or no intervention measures are used; (6) The main organ functions are normal, and there are no severe abnormalities in blood, heart, lung, liver, kidney, bone marrow, or immunodeficiency diseases; (7) The time from the end of the previous use of traditional Chinese medicine and traditional Chinese patent medicines and simple preparations to the start of the study must be ≥ 2 weeks; (8) Those with good compliance can follow up on the efficacy and adverse reactions according to the requirements of the plan; (9) HFS, CIPN, and quality of life assessments were conducted before and after treatment. Exclusion Criteria: (1) Incomplete clinical data; (2) Before treatment, there were poor control of symptoms of diabetes peripheral neuropathy, history of nerve trauma, spinal cord compression syndrome without surgical treatment, spinal canal stenosis or spinal cord nerve root compression, central nervous s…

What they're measuring

CIPN scores

Timeframe: From enrollment to the end of treatment at 8 weeks"

Trial details

NCT IDNCT07375446

SponsorPeking University Third Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-01-31

Contact for this trial

YANHONG YAO

82265857 snowdream246@163.com