Patients With Solid TumorsNCT07375446
Traditional Chinese Medicine Hand-Foot Soak for Chemotherapy-Induced Peripheral Neuropathy and Hand-Foot Syndrome
An observational study of Patients With Solid Tumors, run by Peking University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Solid Tumors
- What is being tested?
- Traditional Chinese Medicine
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- (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.
Who cannot join
- 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.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Patients With Solid Tumors
- Being tested
- Traditional Chinese Medicine
- Keywords
- traditional Chinese medicine (TCM), chemotherapy-induced peripheral neuropathy (CIPN), hand-foot syndrome (HFS)
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese MedicineDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Traditional Chinese Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIPN scores
Measured: From enrollment to the end of treatment at 8 weeks"
Secondary outcomes (1)
HFS Grade
Measured: From enrollment to the end of treatment at 8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Solid TumorsStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375446
- Sponsor's protocol ID
- M20250937
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Traditional Chinese Medicine Hand-Foot Soak for Chemotherapy-Induced Peripheral Neuropathy and Hand-Foot Syndrome
- ClinicalTrials.gov ID
- NCT07375446
- Acronym / sponsor ID
- M20250937
- Conditions
- Patients With Solid Tumors
- Keywords
- traditional Chinese medicine (TCM), chemotherapy-induced peripheral neuropathy (CIPN), hand-foot syndrome (HFS)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese medicine group | – | Drug: Traditional Chinese MedicinePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese MedicineRamulus 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) | Drug | Traditional Chinese medicine group |
Primary outcome
CIPN scores
Time frame: From enrollment to the end of treatment at 8 weeks"
1 secondary outcome
HFS Grade
Time frame: From enrollment to the end of treatment at 8 weeks"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Solid Tumors, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YANHONG YAO (82265857, snowdream246@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIPN scores (time frame: From enrollment to the end of treatment at 8 weeks"). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.