Palmar and Plantar ErythemaEarly Phase 1NCT07883642
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
A Early Phase 1 study testing Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath and Standard Basic Nursing Interventions in people with Palmar and Plantar Erythema and Numbness of the Four Limbs, run by Emeishan Hospital of Traditional Chinese Medicine.
Trial summary
This study is a prospective, single-center, randomized, parallel-group, open-label clinical trial titled "Intervention with the 'Xu Xue Tong Luo Traditional Chinese Medicine Compound for Capecitabine-Related Hand-Foot Syndrome." The research hypothesis is that adding this traditional Chinese medicine hand and foot… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmar and Plantar Erythema, Numbness of the Four Limbs, Pain in the Distal Extremities
- What is being tested?
- Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath and Standard Basic Nursing Interventions
- 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
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Dec 2026
- Phase
- Early Phase 1
- 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
- Age ≥ 18 years， Open to all genders;
- Currently receiving adjuvant or palliative chemotherapy with capecitabine monotherapy or the XELOX regimen, and expected to continue capecitabine treatment;
- Patients with Grade 1-2 hand-foot syndrome as confirmed by CTCAE v5.0 [1], as well as some patients with Grade 3 hand-foot syndrome as assessed by the investigator (those with dry, crusted lesions, old skin lesions, and no signs of acute inflammation) may undergo hand and foot baths;
- ECOG performance status of 0-2, able to independently perform hand and foot baths, and able to attend weekly outpatient follow-up visits;
- Fully informed about all aspects of the study and voluntarily signed a written informed consent form.
Who cannot join
- Patients with Grade 3 CTCAE hand-foot syndrome (with active, extensive ulceration, exudation, or secondary acute bacterial/fungal skin infections) who are not suitable for hand and foot baths; Note: Patients with dry crusting, chronic skin lesions, or no signs of acute inflammation are not excluded;
- Patients with an allergy to any of the Chinese herbal ingredients in the formula when used topically;
- Pregnant or breastfeeding women;
- Patients with baseline severe hepatic or renal impairment, persistent arrhythmias, or prolonged QT interval;
- Patients concurrently taking or applying other herbal preparations containing aconite [9];
- Patients with severe diabetic peripheral neuropathy and significantly diminished pain and temperature sensation in the hands and feet;
- Patients with mental disorders or cognitive impairment who are unable to comply with home herbal baths and follow-up visits.
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 Cpntrolled Trial Protocol of Xuxue Tongluo for Capecitabine-Related Hand-Foot Syndrome
This study is a prospective, single-center, randomized, parallel-group, open-label clinical trial titled "Intervention with the 'Xu Xue Tong Luo Traditional Chinese Medicine Compound for Capecitabine-Related Hand-Foot Syndrome." The research hypothesis is that adding this traditional Chinese medicine hand and foot bath to standard baseline care will result in a significantly higher efficacy rate-defined as a ≥1-grade reduction in Hand-Foot Syndrome (HFS) severity after 3 weeks-compared to baseline care alone.The study plans to enroll 110 patients with capecitabine-related Grade 1-2 HFS (with some eligible Grade 3 patients), who will be randomized in a 1:1 ratio to the control group and the intervention group. The control group will receive standard baseline care; the intervention group will receive standard baseline care supplemented with a fixed 12-ingredient traditional Chinese medicine hand-and-foot bath, in which processed Aconite is pre-decocted to reduce toxicity. Patients will soak their hands and feet in the decoction at 38-41°C at least 4 times per week for 3 consecutive weeks.Primary endpoint: The proportion of patients with a ≥1-grade reduction in HFS score from baseline after 3 weeks of intervention.
Read the detailed description
This study is a prospective, single-center, randomized, parallel-group, open-label clinical trial titled "Intervention with the Xu Xue Tong Luo Traditional Chinese Medicine Compound for Capecitabine-Related Hand-Foot Syndrome." The study plans to enroll 110 patients with Grade 1-2 (and some Grade 3 cases without acute inflammation) capecitabine-related hand-foot syndrome, who will be randomized in a 1:1 ratio to two groups. The control group will receive standard baseline care; the intervention group will additionally receive a fixed 12-ingredient Chinese herbal hand and foot bath, containing processed Aconite, Cinnamomum twig, Asarum, Astragalus, Angelica sinensis, and others. Processed Aconite will be decocted for 30-60 minutes to reduce toxicity. The herbal solution will be maintained at 38-41°C, and patients will soak for 15-20 minutes at least 4 times per week for 3 consecutive weeks. The primary endpoint was the proportion of patients with a ≥1-grade reduction in HFS score after 3 weeks compared to baseline; secondary endpoints included pain NRS, capecitabine dose maintenance rate, EORTC QLQ-C30 quality of life, and time to first improvement. Safety monitoring focused on local skin reactions and aconitine-related symptoms such as numbness of the mouth and tongue, palpitations, and arrhythmias, with follow-up electrocardiograms and liver and kidney function tests. The study employed centralized randomization, concealed allocation, single-blind outcome assessment, and independent statistical analysis, adhering to guidelines such as CONSORT and TIDieR. It is expected to validate the efficacy and safety of the treatment and establish a standardized operating procedure (SOP) for traditional Chinese medicine hand and foot baths.
- Conditions
- Palmar and Plantar Erythema, Numbness of the Four Limbs, Pain in the Distal Extremities, Peeling of the Soles and Palms
- Being tested
- Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath, Standard Basic Nursing Interventions
- Keywords
- Hand-foot syndrome, Traditional Chinese Medicine
- 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.
Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot BathDrug
Prepare a traditional Chinese medicine decoction, maintain the temperature of the decoction between 38 and 41°C, completely submerge both hands and feet in the decoction for 15 to 20 minutes, soak at least 4 times a week, and continue the treatment for 3 consecutive weeks.
Standard Basic Nursing InterventionsOther
- Basic Care: Gently wash hands and feet daily with warm water, and apply a generous amount of non-irritating medical-grade moisturizer to both hands and feet; 2. Education on Daily Protection: Strictly avoid washing with hot water, contact with high-temperature objects, prolonged friction, pressure, and excessive sun exposure. This is the standard Western medical care protocol uniformly recommended by current domestic and international guidelines [3]; 33. Symptomatic Management: For patients with significant pain, use only conventional Western medical symptomatic pain relief; the use of any herbal foot baths or topical herbal preparations is strictly prohibited throughout the entire treatment period; 4. Intervention Period: Provide continuous, standardized care for 3 weeks, with weekly outpatient follow-up evaluations.
| Study group | Role | What they receive |
|---|---|---|
| raditional Chinese medicine fumigation and washing intervention group | Experimental | Standard Basic Care + Hand and Foot Bath with Twelve-Ingredient Processed Sichuan Aconite
1 Fixed Formula (Uniformly and Independently Packaged by the Hospital's Traditional Chinese Medicine Pharmacy) Shenjincao 15 g, Jixueteng 15 g, Processed Sichuan Aconite 10 g, Guizhi 15 g, Yinyanghuo 15 g, Honghua 15 g, Xixin 5 g, Weilingxian 15 g, Huangqi 30 g, Angelica sinensis 15 g, Paeonia rubra 15 g, Artemisia argyi 15 g; The outer packaging must clearly state "For external use only; do not take orally," and separately indicate the requirement to decoct processed Aconite root first.
7.2.2 Standardized Decoction Procedure 1.1. Soak all herbal ingredients in clean water for 30 minutes; 2.2. Add water to the processed Aconite (Zhi Chuan Wu) separately and decoct for 30-60 minutes to reduce toxicity; then add all remaining herbal ingredients. This decoction protocol complies with the Pharmacopoeia and the unified toxicity-reduction standards for external preparations containing Aconite [9]; 3. Receives: Drug: Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath |
| Control Group | Placebo comparator | 1.1. Basic Care: Gently wash hands and feet daily with warm water, and apply a generous amount of non-irritating medical-grade moisturizer to both hands and feet; 2.2. Daily Protection Education: Strictly avoid washing with hot water, contact with high-temperature objects, prolonged friction, pressure, and exposure to direct sunlight. The standard Western medical care protocol is uniformly recommended by current domestic and international guidelines [3]; 3.3. Symptomatic Treatment: For patients with significant pain, use only conventional Western medical symptomatic pain relief; the use of any herbal baths or topical herbal preparations is strictly prohibited throughout the entire treatment period; 4. Intervention Period: Provide continuous, standardized care for 3 weeks, with weekly outpatient follow-up evaluations. Receives: Other: Standard Basic Nursing Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand-Foot Syndrome Grading
Grade 1: Numbness, paresthesia, or tingling in the hands and feet. Grade 2: Discomfort in holding objects or walking; painless swelling or erythema.
Grade 3: Painful erythema, edema of the palms and soles, periungual erythema, and swelling.
Grade 4: Desquamation, ulceration, blistering, and severe pain.
Measured: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
Secondary outcomes (3)
numeric rating scale (NRS) score
The NRS (Numeric Rating Scale) is a simple tool used to assess pain intensity, usually scored from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain.
Measured: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
capecitabine dose maintenance rate
capecitabine dose maintenance rate during the 3-week observation period
Measured: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
Quality of life score (EORTC QLQ-C30)
Measured: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmar and Plantar ErythemaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employs a prospective, randomized, parallel-group design. The specific randomization process is as follows: 1.1. A 1:1 allocation ratio is used via a centralized randomization system (or a computer-generated random sequence combined with the sealed-envelope method); 2.2. Block randomization is employed, with block sizes set at 4-6. A random sequence is generated in advance by an independent statistician to ensure allocation concealment; 3.3. Patients who met the inclusion criteria and signed the informed consent form received a sealed randomization envelope with a corresponding number in the order of enrollment; the study coordinator opened the envelope to determine the group assignment; 4.4. The randomization sequence was kept by an independent statistician; the principal investigator and clinical evaluators did not participate in the randomization process; 5.5. Timing of randomization: Randomization was completed after the informed consent form was signed during the baseli
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (estimated)
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
- NCT07883642
- Sponsor's protocol ID
- Xuxue Tongluo
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 20 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Cpntrolled Trial Protocol of Xuxue Tongluo for Capecitabine-Related Hand-Foot Syndrome
- ClinicalTrials.gov ID
- NCT07883642
- Acronym / sponsor ID
- Xuxue Tongluo
- Conditions
- Palmar and Plantar Erythema, Numbness of the Four Limbs, Pain in the Distal Extremities, Peeling of the Soles and Palms
- Keywords
- Hand-foot syndrome, Traditional Chinese Medicine
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Emeishan Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 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 study is a prospective, single-center, randomized, parallel-group, open-label clinical trial titled "Intervention with the 'Xu Xue Tong Luo Traditional Chinese Medicine Compound for Capecitabine-Related Hand-Foot Syndrome." The research hypothesis is that adding this traditional Chinese medicine hand and foot bath to standard baseline care will result in a significantly higher efficacy rate-defined as a ≥1-grade reduction in Hand-Foot Syndrome (HFS) severity after 3 weeks-compared to baseline care alone.The study plans to enroll 110 patients with capecitabine-related Grade 1-2 HFS (with some eligible Grade 3 patients), who will be randomized in a 1:1 ratio to the control group and the intervention group. The control group will receive standard baseline care; the intervention group will receive standard baseline care supplemented with a fixed 12-ingredient traditional Chinese medicine hand-and-foot bath, in which processed Aconite is pre-decocted to reduce toxicity. Patients will soak their hands and feet in the decoction at 38-41°C at least 4 times per week for 3 consecutive weeks.Primary endpoint: The proportion of patients with a ≥1-grade reduction in HFS score from baseline after 3 weeks of intervention.
Detailed description
This study is a prospective, single-center, randomized, parallel-group, open-label clinical trial titled "Intervention with the Xu Xue Tong Luo Traditional Chinese Medicine Compound for Capecitabine-Related Hand-Foot Syndrome." The study plans to enroll 110 patients with Grade 1-2 (and some Grade 3 cases without acute inflammation) capecitabine-related hand-foot syndrome, who will be randomized in a 1:1 ratio to two groups. The control group will receive standard baseline care; the intervention group will additionally receive a fixed 12-ingredient Chinese herbal hand and foot bath, containing processed Aconite, Cinnamomum twig, Asarum, Astragalus, Angelica sinensis, and others. Processed Aconite will be decocted for 30-60 minutes to reduce toxicity. The herbal solution will be maintained at 38-41°C, and patients will soak for 15-20 minutes at least 4 times per week for 3 consecutive weeks. The primary endpoint was the proportion of patients with a ≥1-grade reduction in HFS score after 3 weeks compared to baseline; secondary endpoints included pain NRS, capecitabine dose maintenance rate, EORTC QLQ-C30 quality of life, and time to first improvement. Safety monitoring focused on local skin reactions and aconitine-related symptoms such as numbness of the mouth and tongue, palpitations, and arrhythmias, with follow-up electrocardiograms and liver and kidney function tests. The study employed centralized randomization, concealed allocation, single-blind outcome assessment, and independent statistical analysis, adhering to guidelines such as CONSORT and TIDieR. It is expected to validate the efficacy and safety of the treatment and establish a standardized operating procedure (SOP) for traditional Chinese medicine hand and foot baths.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study employs a prospective, randomized, parallel-group design. The specific randomization process is as follows: 1.1. A 1:1 allocation ratio is used via a centralized randomization system (or a computer-generated random sequence combined with the sealed-envelope method); 2.2. Block randomization is employed, with block sizes set at 4-6. A random sequence is generated in advance by an independent statistician to ensure allocation concealment; 3.3. Patients who met the inclusion criteria and signed the informed consent form received a sealed randomization envelope with a corresponding number in the order of enrollment; the study coordinator opened the envelope to determine the group assignment; 4.4. The randomization sequence was kept by an independent statistician; the principal investigator and clinical evaluators did not participate in the randomization process; 5.5. Timing of randomization: Randomization was completed after the informed consent form was signed during the baseli
| Arm | Type | Receives |
|---|---|---|
| raditional Chinese medicine fumigation and washing intervention group | Experimental | Drug: Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot BathStandard Basic Care + Hand and Foot Bath with Twelve-Ingredient Processed Sichuan Aconite 1 Fixed Formula (Uniformly and Independently Packaged by the Hospital's Traditional Chinese Medicine Pharmacy) Shenjincao 15 g, Jixueteng 15 g, Processed Sichuan Aconite 10 g, Guizhi 15 g, Yinyanghuo 15 g, Honghua 15 g, Xixin 5 g, Weilingxian 15 g, Huangqi 30 g, Angelica sinensis 15 g, Paeonia rubra 15 g, Artemisia argyi 15 g; The outer packaging must clearly state "For external use only; do not take orally," and separately indicate the requirement to decoct processed Aconite root first. 7.2.2 Standardized Decoction Procedure 1.1. Soak all herbal ingredients in clean water for 30 minutes; 2.2. Add water to the processed Aconite (Zhi Chuan Wu) separately and decoct for 30-60 minutes to reduce toxicity; then add all remaining herbal ingredients. This decoction protocol complies with the Pharmacopoeia and the unified toxicity-reduction standards for external preparations containing Aconite [9]; 3. |
| Control Group | Placebo comparator | Other: Standard Basic Nursing Interventions1.1. Basic Care: Gently wash hands and feet daily with warm water, and apply a generous amount of non-irritating medical-grade moisturizer to both hands and feet; 2.2. Daily Protection Education: Strictly avoid washing with hot water, contact with high-temperature objects, prolonged friction, pressure, and exposure to direct sunlight. The standard Western medical care protocol is uniformly recommended by current domestic and international guidelines [3]; 3.3. Symptomatic Treatment: For patients with significant pain, use only conventional Western medical symptomatic pain relief; the use of any herbal baths or topical herbal preparations is strictly prohibited throughout the entire treatment period; 4. Intervention Period: Provide continuous, standardized care for 3 weeks, with weekly outpatient follow-up evaluations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years， Open to all genders;
- Currently receiving adjuvant or palliative chemotherapy with capecitabine monotherapy or the XELOX regimen, and expected to continue capecitabine treatment;
- Patients with Grade 1-2 hand-foot syndrome as confirmed by CTCAE v5.0 [1], as well as some patients with Grade 3 hand-foot syndrome as assessed by the investigator (those with dry, crusted lesions, old skin lesions, and no signs of acute inflammation) may undergo hand and foot baths;
- ECOG performance status of 0-2, able to independently perform hand and foot baths, and able to attend weekly outpatient follow-up visits;
- Fully informed about all aspects of the study and voluntarily signed a written informed consent form.
Key exclusion criteria (7 listed)
- Patients with Grade 3 CTCAE hand-foot syndrome (with active, extensive ulceration, exudation, or secondary acute bacterial/fungal skin infections) who are not suitable for hand and foot baths; Note: Patients with dry crusting, chronic skin lesions, or no signs of acute inflammation are not excluded;
- Patients with an allergy to any of the Chinese herbal ingredients in the formula when used topically;
- Pregnant or breastfeeding women;
- Patients with baseline severe hepatic or renal impairment, persistent arrhythmias, or prolonged QT interval;
- Patients concurrently taking or applying other herbal preparations containing aconite [9];
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 |
|---|---|---|
| Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot BathPrepare a traditional Chinese medicine decoction, maintain the temperature of the decoction between 38 and 41°C, completely submerge both hands and feet in the decoction for 15 to 20 minutes, soak at least 4 times a week, and continue the treatment for 3 consecutive weeks. | Drug | raditional Chinese medicine fumigation and washing intervention group |
| Standard Basic Nursing Interventions1. Basic Care: Gently wash hands and feet daily with warm water, and apply a generous amount of non-irritating medical-grade moisturizer to both hands and feet; 2. Education on Daily Protection: Strictly avoid washing with hot water, contact with high-temperature objects, prolonged friction, pressure, and excessive sun exposure. This is the standard Western medical care protocol uniformly recommended by current domestic and international guidelines [3]; 33. Symptomatic Management: For patients with significant pain, use only conventional Western medical symptomatic pain relief; the use of any herbal foot baths or topical herbal preparations is strictly prohibited throughout the entire treatment period; 4. Intervention Period: Provide continuous, standardized care for 3 weeks, with weekly outpatient follow-up evaluations. | Other | Control Group |
Primary outcome
Hand-Foot Syndrome Grading
Time frame: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
Grade 1: Numbness, paresthesia, or tingling in the hands and feet. Grade 2: Discomfort in holding objects or walking; painless swelling or erythema. Grade 3: Painful erythema, edema of the palms and soles, periungual erythema, and swelling. Grade 4: Desquamation, ulceration, blistering, and severe pain.
3 secondary outcomes
numeric rating scale (NRS) score
Time frame: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
capecitabine dose maintenance rate
Time frame: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
Quality of life score (EORTC QLQ-C30)
Time frame: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention
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 Oct 2026.
- Individual participant dataSharing planned: Undecided
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 Early Phase 1 study testing Twelve-Ingredient Prepared Sichuan Aconite Hand and Foot Bath and Standard Basic Nursing Interventions in people with Palmar and Plantar Erythema and Numbness of the Four Limbs, run by Emeishan Hospital of Traditional Chinese Medicine.
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 5 inclusion and 7 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 Oct 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 WLiBo Wu (18784644364, 1071089518@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand-Foot Syndrome Grading (time frame: on the day of enrollment, at week 1, at week 3, and on day 7 after completion of the intervention). 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 Oct 2026.