Hand and Foot Bath for Taxane-Induced Peripheral Neurotoxicity

January 16, 2026 updated by: Peking University Cancer Hospital & Institute

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathologically confirmed breast cancer;
  2. Development of grade ≥1 peripheral neurotoxicity after receiving a taxane-containing regimen, with continuation of this regimen for at least two additional cycles;
  3. Age ≥18 years, male or female;
  4. ECOG performance status score 0-1;

  5. Adequate major organ function (cardiac, hepatic, renal, and bone marrow) within 7 days before treatment, meeting the following requirements:

    1. Hematology (without blood transfusion within the previous 14 days):
    2. Hemoglobin (Hb) ≥90 g/L;
    3. Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;
    4. Platelets (PLT) ≥75 × 10⁹/L.

  6. Biochemical tests:

    1. Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN);
    2. ALT and AST ≤2.5 × ULN;
    3. Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min.
  7. Estimated survival ≥6 months;
  8. Signed informed consent.

Exclusion Criteria:

  1. Pre-existing neurological disorders, including peripheral or central neuropathy;
  2. Known allergy to components of the investigational TCM formula;
  3. Neuropathy caused by electrolyte imbalance, diabetes, or other metabolic diseases;
  4. Neuropathy due to nerve compression of any cause;
  5. Concomitant use of other neuroprotective therapies (e.g., nerve growth factor, vitamin B, calcium-magnesium preparations);
  6. Pregnant or lactating women;
  7. Cognitive impairment or psychiatric disorders;
  8. Any other condition considered unsuitable by the investigator.

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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TCM arm
Drug: Traditional Chinese medicine (TCM) hand and foot baths
Traditional Chinese medicine (TCM) formula "Yi-Qi Yang-Xue Tong-Luo Fang" hand and foot baths
Active Comparator: methylcobalamin arm
Drug: Methylcobalamin (methylB12)
methylcobalamin is a commonly used neurotrophic agent in CIPN

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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)
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.
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.

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.
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.

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.
From the first administration of study drug to 6 weeks after the last taxane chemotherapy cycle.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University Cancer Hospital & Institute

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025YJZ98

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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