Post-Chemotherapy Peripheral NeuropathyPhase 2NCT07891403
A Study on the Clinical Efficacy of Fumigation and Washing With Modified Astragalus and Cinnamon Twig Decoction With Five Herbs in the Treatment of Post-Chemotherapy Peripheral Neuropathy
A Phase 2 study testing Traditional Chinese Medicine Steam Bath in people with Post-Chemotherapy Peripheral Neuropathy, run by Emeishan Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This project aims to integrate the knowledge system of Traditional Chinese Medicine (TCM) pattern differentiation with TCM knowledge, combining TCM principles with modern Western pharmacology to fundamentally understand the pathogenesis of chemotherapy-induced peripheral neuropathy (CIPN). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-Chemotherapy Peripheral Neuropathy
- What is being tested?
- Traditional Chinese Medicine Steam Bath
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2025to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Refer to the Chinese Society of Clinical Oncology (CSCO) Clinical Diagnosis and Treatment Guidelines for Common Malignant Tumors, with malignant tumors confirmed by histology or cytology.
- Patients receiving chemotherapy drugs such as oxaliplatin, paclitaxel, and capecitabine
- Karnofsky Performance Status (KPS) ≥ 70 points, Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤ 2 points, survival period ≥ 3 months
- Individuals aged 18 to 80
- Individuals without intellectual or mental disabilities who are capable of completing the questionnaire Exclusion Criteria:：
- Patients with severe cardiac, renal, hepatic, or hematopoietic system impairment;
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- Patients with a history of neuropathy, such as diabetic neuropathy or mechanical nerve injury;
- Patients with drug allergies;
- Patients with skin lesions, a tendency to bleed, or infections;
- Patients with intellectual or psychiatric disabilities who are unable to communicate effectively.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to integrate the knowledge system of Traditional Chinese Medicine (TCM) pattern differentiation with TCM knowledge, combining TCM principles with modern Western pharmacology to fundamentally understand the pathogenesis of chemotherapy-induced peripheral neuropathy (CIPN). It employs herbal fumigation and washing therapy for CIPN, offering novel treatment approaches to better guide and assist clinical practice.
Read the detailed description
Research Methods ：1、A research method combining data collection with clinical application was employed to determine the etiology and pathogenesis of CIPN. The traditional Chinese medicine (TCM) fumigation and washing formula was identified as Modified Huangqi Guizhi Wuwu Decoction: 15 g of Stretching Tendon Grass, 15 g of Chicken Blood Vine, 10 g of Sichuan Aconite, 10 g of Cinnamon Twig, 15 g of Epimedium, 5 g of Safflower, 5 g of Asarum, 15 g of Clematis, Astragalus 15 g, Angelica sinensis 10 g, Paeonia rubra 10 g, and Artemisia argyi 10 g. 2、Subjects were screened according to inclusion and exclusion criteria, and a controlled trial was conducted. Sixty patients were randomly divided into a treatment group and a control group, with 30 patients in each group. Both groups received the following treatment after developing CIPN following administration of oxaliplatin, paclitaxel, and capecitabine: Control Group: Pour 2,000 ml of clean water into the heating pot of the HYZ-IB (2021 model) Traditional Chinese Medicine Steam Therapy Machine, set the preheating temperature to 90°C, and set the steam duration to 30 minutes. Begin steam therapy once the preheating temperature is reached, starting with both upper limbs followed by both lower limbs. Perform once daily; one course of treatment consists of 14 days, and two courses of treatment were administered. Treatment Group: Wrap the Modified Astragalus and Cinnamon Twig Decoction with Five Herbs in gauze, soak it in 2,000 mL of clean water for 10 minutes, and then perform the steam bath using the same method as the control group. 3、 Collect, organize, and analyze the experimental data to draw conclusions.
- Conditions
- Post-Chemotherapy Peripheral Neuropathy
- Being tested
- Traditional Chinese Medicine Steam Bath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine Steam BathDrug
Wrap the Modified Astragalus and Cinnamon Twig Decoction with Five Ingredients in gauze, soak it in 2,000 ml of clean water for 10 minutes, then pour it into the heating chamber of the steam therapy machine. Set the preheating temperature to 90°C. set the fumigation time to 30 minutes, and begin fumigation once the preheating temperature is reached. Start with both upper limbs, followed by both lower limbs. Perform once daily; one course of treatment consists of 14 days, and a total of two courses of treatment are recommended.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine Fumigation and Bathing Group | Experimental | Take Methylcobalamin tablets + herbal steam bath Receives: Drug: Traditional Chinese Medicine Steam Bath |
| Clear Water Fumigation and Washing Group | Placebo comparator | Take methylcobalamin tablets + warm water steam bath Receives: Drug: Traditional Chinese Medicine Steam Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Experience
Numbness, pain, and abnormal sensations in the hands and feet
Measured: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
CIPN Grading Criteria
On a scale of 0 to 4: Level 0: Asymptomatic; Level 1: Absence of tendon reflexes or numbness (including a prickling sensation), but with no impact on function Level 2: Sensory loss or numbness (including a prickling sensation), affecting function but not daily living activities Level 3: Sensory loss or numbness (including a prickling sensation), affecting daily living activities Level 4: Long-term sensory loss, affecting function
Measured: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
Quality of Life Questionnaire QLQ-C30
(Original Total Score - Number of Questions) / (Number of Questions × 3) × 100，0-19 points: Level 0 (asymptomatic); 20-39 points: Level 1 (mild); 40-69 points: Level 2 (moderate);70-100 points: Levels 3-4 (severe)
Measured: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
Hospital Anxiety and Depression Scale
Add up the scores for the 7 questions：0-7 points Normal range, 8-10 points Mild, 11-14 points Moderate, 15-21 points Severe
Measured: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start29 May 2025
- Primary completion20 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Chemotherapy Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a parallel-group controlled trial in which participants were randomly assigned to the treatment group and the control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emeishan Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wu Libo, Emeishan Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891403
- Sponsor's protocol ID
- EmeishanHTCM
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Clinical Efficacy of Fumigation and Washing With Modified Astragalus and Cinnamon Twig Decoction With Five Herbs in the Treatment of Post-Chemotherapy Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07891403
- Acronym / sponsor ID
- EmeishanHTCM
- Conditions
- Post-Chemotherapy Peripheral Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Emeishan Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 29 May 2025 (actual)
- Primary completion
- 20 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 23 Oct 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.
This project aims to integrate the knowledge system of Traditional Chinese Medicine (TCM) pattern differentiation with TCM knowledge, combining TCM principles with modern Western pharmacology to fundamentally understand the pathogenesis of chemotherapy-induced peripheral neuropathy (CIPN). It employs herbal fumigation and washing therapy for CIPN, offering novel treatment approaches to better guide and assist clinical practice.
Detailed description
Research Methods ：1、A research method combining data collection with clinical application was employed to determine the etiology and pathogenesis of CIPN. The traditional Chinese medicine (TCM) fumigation and washing formula was identified as Modified Huangqi Guizhi Wuwu Decoction: 15 g of Stretching Tendon Grass, 15 g of Chicken Blood Vine, 10 g of Sichuan Aconite, 10 g of Cinnamon Twig, 15 g of Epimedium, 5 g of Safflower, 5 g of Asarum, 15 g of Clematis, Astragalus 15 g, Angelica sinensis 10 g, Paeonia rubra 10 g, and Artemisia argyi 10 g. 2、Subjects were screened according to inclusion and exclusion criteria, and a controlled trial was conducted. Sixty patients were randomly divided into a treatment group and a control group, with 30 patients in each group. Both groups received the following treatment after developing CIPN following administration of oxaliplatin, paclitaxel, and capecitabine: Control Group: Pour 2,000 ml of clean water into the heating pot of the HYZ-IB (2021 model) Traditional Chinese Medicine Steam Therapy Machine, set the preheating temperature to 90°C, and set the steam duration to 30 minutes. Begin steam therapy once the preheating temperature is reached, starting with both upper limbs followed by both lower limbs. Perform once daily; one course of treatment consists of 14 days, and two courses of treatment were administered. Treatment Group: Wrap the Modified Astragalus and Cinnamon Twig Decoction with Five Herbs in gauze, soak it in 2,000 mL of clean water for 10 minutes, and then perform the steam bath using the same method as the control group. 3、 Collect, organize, and analyze the experimental data to draw conclusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was a parallel-group controlled trial in which participants were randomly assigned to the treatment group and the control group.
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine Fumigation and Bathing Group | Experimental | Drug: Traditional Chinese Medicine Steam BathTake Methylcobalamin tablets + herbal steam bath |
| Clear Water Fumigation and Washing Group | Placebo comparator | Drug: Traditional Chinese Medicine Steam BathTake methylcobalamin tablets + warm water steam bath |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Refer to the Chinese Society of Clinical Oncology (CSCO) Clinical Diagnosis and Treatment Guidelines for Common Malignant Tumors, with malignant tumors confirmed by histology or cytology.
- Patients receiving chemotherapy drugs such as oxaliplatin, paclitaxel, and capecitabine
- Karnofsky Performance Status (KPS) ≥ 70 points, Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤ 2 points, survival period ≥ 3 months
- Individuals aged 18 to 80
- Individuals without intellectual or mental disabilities who are capable of completing the questionnaire Exclusion Criteria:：
Key exclusion criteria (0 listed)
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 Medicine Steam BathWrap the Modified Astragalus and Cinnamon Twig Decoction with Five Ingredients in gauze, soak it in 2,000 ml of clean water for 10 minutes, then pour it into the heating chamber of the steam therapy machine. Set the preheating temperature to 90°C. set the fumigation time to 30 minutes, and begin fumigation once the preheating temperature is reached. Start with both upper limbs, followed by both lower limbs. Perform once daily; one course of treatment consists of 14 days, and a total of two courses of treatment are recommended. | Drug | Clear Water Fumigation and Washing Group, Traditional Chinese Medicine Fumigation and Bathing Group |
Primary outcome
Patient Experience
Time frame: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
Numbness, pain, and abnormal sensations in the hands and feet
CIPN Grading Criteria
Time frame: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
On a scale of 0 to 4: Level 0: Asymptomatic; Level 1: Absence of tendon reflexes or numbness (including a prickling sensation), but with no impact on function Level 2: Sensory loss or numbness (including a prickling sensation), affecting function but not daily living activities Level 3: Sensory loss or numbness (including a prickling sensation), affecting daily living activities Level 4: Long-term sensory loss, affecting function
Quality of Life Questionnaire QLQ-C30
Time frame: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
(Original Total Score - Number of Questions) / (Number of Questions × 3) × 100，0-19 points: Level 0 (asymptomatic); 20-39 points: Level 1 (mild); 40-69 points: Level 2 (moderate);70-100 points: Levels 3-4 (severe)
Hospital Anxiety and Depression Scale
Time frame: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.
Add up the scores for the 7 questions：0-7 points Normal range, 8-10 points Mild, 11-14 points Moderate, 15-21 points Severe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Traditional Chinese Medicine Steam Bath in people with Post-Chemotherapy Peripheral Neuropathy, run by Emeishan Hospital of Traditional Chinese Medicine at 1 site in China.
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 10 inclusion and 0 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: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Experience (time frame: On days 1, 3, and 5 after fumigation, as well as during the second week and at one month.). The study lists 4 primary outcomes in all. 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 23 Oct 2026.