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

January 21, 2026 updated by: Peking University Third Hospital

Efficacy and Safety of a Traditional Chinese Medicine Hand-Foot Soak for Chemotherapy-Induced Peripheral Neuropathy and Hand-Foot Syndrome

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study will enroll patients with solid tumors who received systemic anticancer therapy at the Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital.

Description

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 system tumors; (3) Individuals with a known history of allergies to the components of this medication regimen; (4) Other situations that researchers believe are not suitable for inclusion.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Traditional Chinese medicine group

Patients received a topical TCM treatment. The formula consisted of: Ramulus Cinnamomi (Guizhi), Radix Angelicae Sinensis (Danggui) , Radix Aconiti Lateralis Preparata (Zhi Chuanwu) , Caulis Spatholobi (Jixueteng), Rhizoma Chuanxiong (Chuanxiong) , Radix Astragali (Huangqi), Rhizoma Dioscoreae Nipponicae (Chuanshanlong) , Herba Speranskiae Tuberculatae (Tougucao), Radix Paeoniae Rubra (Chishao), and Radix Sophorae Flavescentis (Kushen Pian).

The herbs were decocted in 1000-2000ml of 37-41℃ water. Patients were instructed to soak their hands and feet in the warm solution for 20-30 minutes twice daily.
Drug: Traditional Chinese Medicine
Ramulus Cinnamomi (Guizhi) , Radix Angelicae Sinensis (Danggui) , Radix Aconiti Lateralis Preparata (Zhi Chuanwu), Caulis Spatholobi (Jixueteng) , Rhizoma Chuanxiong (Chuanxiong) , Radix Astragali (Huangqi) , Rhizoma Dioscoreae Nipponicae (Chuanshanlong) , Herba Speranskiae Tuberculatae (Tougucao) , Radix Paeoniae Rubra (Chishao) , and Radix Sophorae Flavescentis (Kushen Pian)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CIPN scores
Time Frame: From enrollment to the end of treatment at 8 weeks"
From enrollment to the end of treatment at 8 weeks"

Secondary Outcome Measures

Outcome Measure
Time Frame
HFS Grade
Time Frame: From enrollment to the end of treatment at 8 weeks"
From enrollment to the end of treatment at 8 weeks"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Third Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20250937

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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