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Not yet recruitingNCT07375446Updated Jan 29, 2026

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

An observational study in Patients With Solid Tumors, sponsored by Peking University Third Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Peking University Third Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Patients With Solid Tumors

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Keywords

  • traditional Chinese medicine (TCM), chemotherapy-induced peripheral neuropathy (CIPN), hand-foot syndrome (HFS)
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

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 design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • DrugTraditional 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)

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What researchers measure

Primary outcomes

  1. CIPN scores

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

Secondary outcomes

  1. HFS Grade

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07375446
Lead sponsor
Peking University Third Hospital
Responsible party
Sponsor
First posted
Jan 29, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Jan 31, 2029 (estimated)
Completion
Jan 31, 2029 (estimated)
Last update
Jan 29, 2026

Study contacts

YANHONG YAO
Contact
snowdream246@163.com
82265857

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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