Hand-Foot SyndromeNCT06583369
The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs
A study testing Liangxue ointment（Traditional Chinese Ointment） and Urea cream in people with Hand-Foot Syndrome, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
This study was a prospective, single-center randomized controlled trial. The subject of this study is to evaluate the effectiveness and safety of traditional Chinese medicine Liangxue Ointment in the treatment of hand-foot syndrome caused by VEGFR-TKI drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand-Foot Syndrome
- What is being tested?
- Liangxue ointment（Traditional Chinese Ointment） and Urea cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2024to 25 Mar 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old, both men and women are welcome;
- Patients with pathologically confirmed malignant tumors;
- Receive treatment with VEGFR-TKI drugs;
- Hand-foot syndrome associated with VEGFR-TKI drugs is judged by the researcher;
- No skin lesions on hands and feet before receiving VEGFR-TKI drug treatment;
- No allergies to the traditional Chinese medicine components of the trial drug;
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- Be conscious, have language expression or reading skills, and can communicate normally;
- Estimated survival time ≥3 months;
- ECOG score ≤ 2;
- Ability to comply with the trial protocol, as judged by the investigator;
- Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of the trial drug; men of reproductive potential or women with the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, oral contraceptives, Intrauterine device, libido control or barrier method combined with spermicide) and continue contraception for 6 months after the end of treatment;
- Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the written informed consent form.
Who cannot join
- Those with skin ulcers on hands and feet;
- Known allergy to ingredients of Liangxue Ointment;
- Have used other targeted drugs and chemotherapy drugs that cause HFS within 4 weeks;
- Those who have skin lesions on their hands and feet before treatment with VEGFR-TKI drugs or those who have a history of skin diseases;
- Use of medications within 2 weeks that may affect study results (topical antibiotics, topical steroids, and other topical treatments);
- With serious accompanying diseases, such as severe hypertension, diabetes, thyroid disease, heart disease, and mental illness;
- Poor compliance and refusal to cooperate with follow-up visits;
- Other reasons lead the researcher to believe that they are not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100142
Lu Si, MD, +86(10)88196951, silu.net@hotmail.com
Lu Si, MD
About this study
This study was a prospective, single-center randomized controlled trial. The subject of this study is to evaluate the effectiveness and safety of traditional Chinese medicine Liangxue Ointment in the treatment of hand-foot syndrome caused by VEGFR-TKI drugs.
Read the detailed description
This study was a prospective, single-center randomized controlled trial. Patients with hand-foot syndrome caused by VEGFR-TKI drugs were randomly divided into the experimental group and the control group at a ratio of 1:1 according to the numerical randomization method. All patients are required to avoid inappropriate local friction of hands and feet; avoid heavy physical labor and sun exposure; eat a light diet, avoid spicy and irritating foods, and keep warm. The control group received urea cream application, and the experimental group received Liangxue ointment application.
- Conditions
- Hand-Foot Syndrome
- Being tested
- Liangxue ointment（Traditional Chinese Ointment）, Urea cream
- Keywords
- axitinib, Hand-Foot Syndrome, renal cell carcinoma, Melanoma, VEGFR-TKI
- Medical subject headings
- Hand-Foot Syndrome, Carcinoma, Renal Cell, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liangxue ointment（Traditional Chinese Ointment）Drug
The main ingredients of Liangxue Ointment include: Lithospermum sibiricum, Sanguisorba Sanguis, Rehmannia glutinosa, Gardenia, rhubarb, skullcap, borneol, dragon's blood, olibanum and myrrh.
Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.
Urea creamDrug
Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.
| Study group | Role | What they receive |
|---|---|---|
| Liangxue ointment | Experimental | Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses. Receives: Drug: Liangxue ointment（Traditional Chinese Ointment） |
| urea cream | Active comparator | Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses. Receives: Drug: Urea cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-week treatment effectiveness
According to the patient's NCI CTCAE grade improvement, it is divided into: 1) The clinical symptoms completely disappear, which is a complete remission; 2) The symptom grade decreases by 1 level or more (not including falling to level 0), which is a partial remission; 3) There is no change in symptoms. , is invalid. Calculate the treatment effectiveness at different time points respectively, and take the 2-week treatment effectiveness as the main research endpoint.
Measured: Participants will be followed for an expected average of 4 weeks
Secondary outcomes (3)
Quality of life improvement value
Quality of life improvement value: According to the HFS-14 scale, patients' quality of life scores were scored before and after treatment. Quality of life improvement value = quality of life score before treatment - quality of life score after treatment. The quality of life improvement values were calculated each week during treatment, 2 weeks, and 4 weeks after the end of treatment.
Measured: The quality of life improvement values were calculated each week during treatment, 2 weeks, and 4 weeks after the end of treatment.
Pain relief rate
Pain relief rate: The NRS numerical scoring method is used to evaluate the pain before and after treatment: 1) The disappearance of pain after treatment is complete relief; 2) The pain score after treatment / the pain score before treatment ≤50% is effective; 3) There is no change in pain, which is invalid. Pain relief rate = (number of complete relief cases + number of effective cases)/total number of cases × 100%.
Measured: Participants will be followed for an expected average of 4 weeks
Drug discontinuation and dose reduction rate
Drug discontinuation and dose reduction: the rate of drug discontinuation or dose reduction in the two groups due to severe hand-foot syndrome caused by VEGFR-TKI drugs.
Measured: Participants will be followed for an expected average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start25 Mar 2024
- Primary completion25 Mar 2025 (estimated)
- Study completion25 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand-Foot SyndromeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Si, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583369
- Sponsor's protocol ID
- 2022YJZ82
- Status last verified
- Apr 2024
- First submitted
- 1 Sep 2024
- Last updated
- 4 Sep 2024
- 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 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Liangxue Ointment in the Treatment of Hand-foot Syndrome Caused by VEGFR-TKI Drugs
- ClinicalTrials.gov ID
- NCT06583369
- Acronym / sponsor ID
- 2022YJZ82
- Conditions
- Hand-Foot Syndrome
- Keywords
- axitinib, Hand-Foot Syndrome, renal cell carcinoma, Melanoma, VEGFR-TKI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 25 Mar 2025 (estimated)
- First posted
- 4 Sep 2024 (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 was a prospective, single-center randomized controlled trial. The subject of this study is to evaluate the effectiveness and safety of traditional Chinese medicine Liangxue Ointment in the treatment of hand-foot syndrome caused by VEGFR-TKI drugs.
Detailed description
This study was a prospective, single-center randomized controlled trial. Patients with hand-foot syndrome caused by VEGFR-TKI drugs were randomly divided into the experimental group and the control group at a ratio of 1:1 according to the numerical randomization method. All patients are required to avoid inappropriate local friction of hands and feet; avoid heavy physical labor and sun exposure; eat a light diet, avoid spicy and irritating foods, and keep warm. The control group received urea cream application, and the experimental group received Liangxue ointment application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liangxue ointment | Experimental | Drug: Liangxue ointment（Traditional Chinese Ointment）Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses. |
| urea cream | Active comparator | Drug: Urea creamApply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- ≥18 years old, both men and women are welcome;
- Patients with pathologically confirmed malignant tumors;
- Receive treatment with VEGFR-TKI drugs;
- Hand-foot syndrome associated with VEGFR-TKI drugs is judged by the researcher;
- No skin lesions on hands and feet before receiving VEGFR-TKI drug treatment;
Key exclusion criteria (8 listed)
- Those with skin ulcers on hands and feet;
- Known allergy to ingredients of Liangxue Ointment;
- Have used other targeted drugs and chemotherapy drugs that cause HFS within 4 weeks;
- Those who have skin lesions on their hands and feet before treatment with VEGFR-TKI drugs or those who have a history of skin diseases;
- Use of medications within 2 weeks that may affect study results (topical antibiotics, topical steroids, and other topical treatments);
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 |
|---|---|---|
| Liangxue ointment（Traditional Chinese Ointment）The main ingredients of Liangxue Ointment include: Lithospermum sibiricum, Sanguisorba Sanguis, Rehmannia glutinosa, Gardenia, rhubarb, skullcap, borneol, dragon's blood, olibanum and myrrh. Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses. | Drug | Liangxue ointment |
| Urea creamApply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses. | Drug | urea cream |
Primary outcome
2-week treatment effectiveness
Time frame: Participants will be followed for an expected average of 4 weeks
According to the patient's NCI CTCAE grade improvement, it is divided into: 1) The clinical symptoms completely disappear, which is a complete remission; 2) The symptom grade decreases by 1 level or more (not including falling to level 0), which is a partial remission; 3) There is no change in symptoms. , is invalid. Calculate the treatment effectiveness at different time points respectively, and take the 2-week treatment effectiveness as the main research endpoint.
3 secondary outcomes
Quality of life improvement value
Time frame: The quality of life improvement values were calculated each week during treatment, 2 weeks, and 4 weeks after the end of treatment.
Pain relief rate
Time frame: Participants will be followed for an expected average of 4 weeks
Drug discontinuation and dose reduction rate
Time frame: Participants will be followed for an expected average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liangxue ointment（Traditional Chinese Ointment） and Urea cream in people with Hand-Foot Syndrome, run by Peking University Cancer Hospital & Institute 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 12 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: status not confirmed, as of the sponsor's last update on 4 Sep 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-week treatment effectiveness (time frame: Participants will be followed for an expected average of 4 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 4 Sep 2024.