An interventional study of Liangxue ointment（Traditional Chinese Ointment） and Urea cream in Hand-Foot Syndrome, sponsored by Peking University Cancer Hospital & Institute. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Peking University Cancer Hospital & Institute · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.
Drug: Liangxue ointment（Traditional Chinese Ointment）
Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.
Drug: Urea cream
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.
Apply 2 times a day, 14 days is a course of treatment, and the treatment is 2 courses.
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.
Time frame: Participants will be followed for an expected average of 4 weeks
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.
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
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%.
Time frame: 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.
Time frame: Participants will be followed for an expected average of 4 weeks
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peking University Cancer Hospital & Institute