Breast CancerPhase 4NCT07344974
Hand and Foot Bath for Taxane-Induced Peripheral Neurotoxicity
A Phase 4 study testing Traditional Chinese medicine (TCM) hand and foot baths and Methylcobalamin (methylB12) in people with Breast Cancer, run by Peking University Cancer Hospital & Institute.
Trial summary
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting toxicity of taxane-based agents, with an incidence of 57%-83%. Patients frequently develop fingertip numbness, reduced tactile sensation, and other neuropathic symptoms, which significantly impair quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Traditional Chinese medicine (TCM) hand and foot baths and Methylcobalamin (methylB12)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 2027
- Phase
- Phase 4
- 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
Who may be able to join
- Pathologically confirmed breast cancer;
- Development of grade ≥1 peripheral neurotoxicity after receiving a taxane-containing regimen, with continuation of this regimen for at least two additional cycles;
- Age ≥18 years, male or female;
- ECOG performance status score 0-1;
- Adequate major organ function (cardiac, hepatic, renal, and bone marrow) within 7 days before treatment, meeting the following requirements:
- Hematology (without blood transfusion within the previous 14 days):
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- Hemoglobin (Hb) ≥90 g/L;
- Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
- Platelets (PLT) ≥75 × 10⁹/L.
- Biochemical tests:
- Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN);
- ALT and AST ≤2.5 × ULN;
- Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min.
- Estimated survival ≥6 months;
- Signed informed consent.
Who cannot join
- Pre-existing neurological disorders, including peripheral or central neuropathy;
- Known allergy to components of the investigational TCM formula;
- Neuropathy caused by electrolyte imbalance, diabetes, or other metabolic diseases;
- Neuropathy due to nerve compression of any cause;
- Concomitant use of other neuroprotective therapies (e.g., nerve growth factor, vitamin B, calcium-magnesium preparations);
- Pregnant or lactating women;
- Cognitive impairment or psychiatric disorders;
- Any other condition considered unsuitable by the investigator.
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: A Randomized Controlled Single-Center Clinical Trial of Traditional Chinese Medicine Hand and Foot Bath for Taxane-Induced Peripheral Neurotoxicity
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting toxicity of taxane-based agents, with an incidence of 57%-83%. Patients frequently develop fingertip numbness, reduced tactile sensation, and other neuropathic symptoms, which significantly impair quality of life. The severity of CIPN is strongly associated with cumulative drug dosage. Current management strategies remain inadequate, and no high-level clinical recommendations are available.
Traditional Chinese medicine (TCM) hand and foot baths have been widely applied in clinical practice due to their convenience, low cost, and high patient acceptance. The formula "Yi-Qi Yang-Xue Tong-Luo Fang," developed by the TCM Department of our hospital. Preliminary clinical use has shown reliable efficacy and good tolerability, suggesting potential benefit for CIPN.
Read more
This randomized, controlled clinical trial aims to evaluate the efficacy and safety of the TCM hand and foot bath compared with methylcobalamin (a commonly used neurotrophic agent) for paclitaxel-induced CIPN. Peripheral neurotoxicity will be assessed using standardized measures, including the Common Terminology Criteria for Adverse Events (CTCAE), the Total Neuropathy Score-clinical version (TNSc), and the M. D. Anderson Symptom Inventory with TCM module (MDASI-TCM). Changes in scores between groups will be compared to determine relative effectiveness.
Quality of life will be evaluated using validated international scales, specifically the EORTC Quality of Life Questionnaire for Breast Cancer Patients (EORTC QLQ-BR23) and the core questionnaire (EORTC QLQ-C30). These tools will provide multidimensional evaluation of treatment impact on daily functioning and well-being.
The study is expected to generate evidence on both efficacy and safety of this TCM formula, clarify its potential role in preventing or reducing CIPN progression, and assess its influence on patients' quality of life. The findings will provide clinical data to support TCM-based interventions as complementary strategies for managing chemotherapy-induced neurotoxicity.
- Conditions
- Breast Cancer
- Being tested
- Traditional Chinese medicine (TCM) hand and foot baths, Methylcobalamin (methylB12)
- Keywords
- breast cancer, Chemotherapy-induced peripheral neuropathy, Traditional Chinese Medicine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese medicine (TCM) hand and foot bathsDrug
Traditional Chinese medicine (TCM) formula "Yi-Qi Yang-Xue Tong-Luo Fang" hand and foot baths
Methylcobalamin (methylB12)Drug
methylcobalamin is a commonly used neurotrophic agent in CIPN
| Study group | Role | What they receive |
|---|---|---|
| TCM arm | Experimental | Not described Receives: Drug: Traditional Chinese medicine (TCM) hand and foot baths |
| methylcobalamin arm | Active comparator | Not described Receives: Drug: Methylcobalamin (methylB12) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 as Assessed by CTCAE v5.0
Peripheral neurotoxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Neurotoxicity progression is defined as an increase of ≥1 CTCAE grade from baseline. Controlled peripheral neurotoxicity is defined as stable or improved CTCAE grade compared with baseline. The outcome will be summarized as the proportion of participants with controlled peripheral neurotoxicity at week 6.
Measured: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.
Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 Assessed by the MD Anderson Symptom Inventory-Traditional Chinese Medicine Module (MDASI-TCM)
Symptom severity will be assessed using the MD Anderson Symptom Inventory-Traditional Chinese Medicine module (MDASI-TCM). Changes in symptom burden will be evaluated by comparing MDASI-TCM scores from baseline to week 6. The outcome will be summarized as the proportion of participants with controlled peripheral neurotoxicity in MDASI-TCM score at week 6.
Measured: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.
Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 as Assessed by Total Neuropathy Score-Clinical Version (TNSc)
Peripheral neuropathy severity will be assessed using the Total Neuropathy Score-Clinical version (TNSc). Changes in peripheral neuropathy severity will be evaluated by comparing TNSc scores from baseline to week 6. The outcome will be summarized as the proportion of participants with controlled peripheral neurotoxicity at week 6.
Measured: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.
Secondary outcomes (3)
Time to Peripheral Neurotoxicity Progression as Assessed by CTCAE v5.0
Time to peripheral neurotoxicity progression is defined as the time interval from the first administration of the study intervention to the first documented occurrence of peripheral neurotoxicity progression, as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Neurotoxicity progression is defined as an increase of ≥1 CTCAE grade from baseline. Participants without documented progression will be censored at the date of the last neurotoxicity assessment.
Measured: From the first administration of study drug to the date of first documented neurotoxicity progression, as assessed by CTCAE criteria, up to 6 weeks after the last cycle of taxane chemotherapy.
Change from Baseline in Quality of Life Scores (EORTC QLQ-C30 and QLQ-BR23)
Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the Breast Cancer-Specific Module (EORTC QLQ-BR23).
Changes in global health status and functional and symptom scales from baseline will be analyzed to evaluate the impact of the intervention on patients' quality of life.
Measured: From baseline (within 7 days before treatment initiation) to every 2 chemotherapy cycles, until 6 weeks after the last taxane chemotherapy.
Incidence of Adverse Events
All adverse events (AEs) occurring during the study will be recorded, including onset date, duration, severity (graded per CTCAE v5.0), management, and outcome. Investigators will assess the causal relationship between each AE and the study treatment, and document all findings in the case report form with signature and date.
The number and percentage of participants experiencing treatment-related AEs will be summarized by severity grade and system organ class.
Measured: From the first administration of study drug to 6 weeks after the last taxane chemotherapy cycle.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344974
- Sponsor's protocol ID
- 2025YJZ98
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Single-Center Clinical Trial of Traditional Chinese Medicine Hand and Foot Bath for Taxane-Induced Peripheral Neurotoxicity
- ClinicalTrials.gov ID
- NCT07344974
- Acronym / sponsor ID
- 2025YJZ98
- Conditions
- Breast Cancer
- Keywords
- breast cancer, Chemotherapy-induced peripheral neuropathy, Traditional Chinese Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 15 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.
Chemotherapy-induced peripheral neuropathy (CIPN) is a common and dose-limiting toxicity of taxane-based agents, with an incidence of 57%-83%. Patients frequently develop fingertip numbness, reduced tactile sensation, and other neuropathic symptoms, which significantly impair quality of life. The severity of CIPN is strongly associated with cumulative drug dosage. Current management strategies remain inadequate, and no high-level clinical recommendations are available.
Traditional Chinese medicine (TCM) hand and foot baths have been widely applied in clinical practice due to their convenience, low cost, and high patient acceptance. The formula "Yi-Qi Yang-Xue Tong-Luo Fang," developed by the TCM Department of our hospital. Preliminary clinical use has shown reliable efficacy and good tolerability, suggesting potential benefit for CIPN.
This randomized, controlled clinical trial aims to evaluate the efficacy and safety of the TCM hand and foot bath compared with methylcobalamin (a commonly used neurotrophic agent) for paclitaxel-induced CIPN. Peripheral neurotoxicity will be assessed using standardized measures, including the Common Terminology Criteria for Adverse Events (CTCAE), the Total Neuropathy Score-clinical version (TNSc), and the M. D. Anderson Symptom Inventory with TCM module (MDASI-TCM). Changes in scores between groups will be compared to determine relative effectiveness.
Quality of life will be evaluated using validated international scales, specifically the EORTC Quality of Life Questionnaire for Breast Cancer Patients (EORTC QLQ-BR23) and the core questionnaire (EORTC QLQ-C30). These tools will provide multidimensional evaluation of treatment impact on daily functioning and well-being.
The study is expected to generate evidence on both efficacy and safety of this TCM formula, clarify its potential role in preventing or reducing CIPN progression, and assess its influence on patients' quality of life. The findings will provide clinical data to support TCM-based interventions as complementary strategies for managing chemotherapy-induced neurotoxicity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM arm | Experimental | Drug: Traditional Chinese medicine (TCM) hand and foot baths |
| methylcobalamin arm | Active comparator | Drug: Methylcobalamin (methylB12) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pathologically confirmed breast cancer;
- Development of grade ≥1 peripheral neurotoxicity after receiving a taxane-containing regimen, with continuation of this regimen for at least two additional cycles;
- Age ≥18 years, male or female;
- ECOG performance status score 0-1;
- Adequate major organ function (cardiac, hepatic, renal, and bone marrow) within 7 days before treatment, meeting the following requirements:
Key exclusion criteria (8 listed)
- Pre-existing neurological disorders, including peripheral or central neuropathy;
- Known allergy to components of the investigational TCM formula;
- Neuropathy caused by electrolyte imbalance, diabetes, or other metabolic diseases;
- Neuropathy due to nerve compression of any cause;
- Concomitant use of other neuroprotective therapies (e.g., nerve growth factor, vitamin B, calcium-magnesium preparations);
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 (TCM) hand and foot bathsTraditional Chinese medicine (TCM) formula "Yi-Qi Yang-Xue Tong-Luo Fang" hand and foot baths | Drug | TCM arm |
| Methylcobalamin (methylB12)methylcobalamin is a commonly used neurotrophic agent in CIPN | Drug | methylcobalamin arm |
Primary outcome
Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 as Assessed by CTCAE v5.0
Time frame: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.
Peripheral neurotoxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Neurotoxicity progression is defined as an increase of ≥1 CTCAE grade from baseline. Controlled peripheral neurotoxicity is defined as stable or improved CTCAE grade compared with baseline. The outcome will be summarized as the proportion of participants with controlled peripheral neurotoxicity at week 6.
Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 Assessed by the MD Anderson Symptom Inventory-Traditional Chinese Medicine Module (MDASI-TCM)
Time frame: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.
Symptom severity will be assessed using the MD Anderson Symptom Inventory-Traditional Chinese Medicine module (MDASI-TCM). Changes in symptom burden will be evaluated by comparing MDASI-TCM scores from baseline to week 6. The outcome will be summarized as the proportion of participants with controlled peripheral neurotoxicity in MDASI-TCM score at week 6.
Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 as Assessed by Total Neuropathy Score-Clinical Version (TNSc)
Time frame: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.
Peripheral neuropathy severity will be assessed using the Total Neuropathy Score-Clinical version (TNSc). Changes in peripheral neuropathy severity will be evaluated by comparing TNSc scores from baseline to week 6. The outcome will be summarized as the proportion of participants with controlled peripheral neurotoxicity at week 6.
3 secondary outcomes
Time to Peripheral Neurotoxicity Progression as Assessed by CTCAE v5.0
Time frame: From the first administration of study drug to the date of first documented neurotoxicity progression, as assessed by CTCAE criteria, up to 6 weeks after the last cycle of taxane chemotherapy.
Change from Baseline in Quality of Life Scores (EORTC QLQ-C30 and QLQ-BR23)
Time frame: From baseline (within 7 days before treatment initiation) to every 2 chemotherapy cycles, until 6 weeks after the last taxane chemotherapy.
Incidence of Adverse Events
Time frame: From the first administration of study drug to 6 weeks after the last taxane chemotherapy cycle.
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 20 Jan 2026.
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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?
A Phase 4 study testing Traditional Chinese medicine (TCM) hand and foot baths and Methylcobalamin (methylB12) in people with Breast Cancer, run by Peking University Cancer Hospital & Institute.
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 15 inclusion and 8 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 20 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Bin Shao, MD (+86-010-88196380, shaobin79@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Controlled Peripheral Neurotoxicity at Week 6 as Assessed by CTCAE v5.0 (time frame: From baseline (within 7 days before the first administration of study drug) to 6 weeks ±7 days after treatment initiation; assessments will continue every 6 weeks until 6 weeks after the last cycle of taxane chemotherapy.). The study lists 3 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 20 Jan 2026.