- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04592731
Acetylated Natural Nucleotides in Treating Hand-foot Syndrome
February 27, 2023 updated by: Nan xu
A Clinical Trial to Evaluate the Efficacy and Safety of Acetylated Natural Nucleotides in Treating Hand-foot Syndrome (HFS)
The clinical trial is planned to investigate the efficacy and safety of acetylated natural nucleotides in treating anti-cancer medications induced hand-foot syndrome (HFS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200120
- Shanghai East Hospital
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-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18 years of age or older.
- Pathologically confirmed cancer receiving capecitabine-based anti-cancer therapy (capecitabine with or without other anti-cancer drugs).
- With HFS determined by "CTCAE v5.0 - PPE" as grade 2 or above.
- Able to use topical medications and complete questionnaires reliably with or without assistance.
- ECOG performance score < 2.
Exclusion Criteria:
- Has HFS due to other medications and does not recover within 4 weeks prior to baseline.
- Other skin disorders that will affect efficacy evaluation on the hands and feet, including but not limited to: tinea of feet and hands, hand/foot eczema, palmoplantar pustulosis, palmoplantar keratosis, acrodermatitis continua etc.
- Uncontrolled intercurrent illness as determined by the investigator including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, uncontrolled hypotension or hypertension, cardiac arrhythmia, or psychiatric illness and social situations that would limit compliance with study requirements.
Significantly abnormal lab test:
Inadequate hematologic function as indicated by:
- Absolute neutrophil counts (ANC) < 1,500 /mm^3
- Hemoglobin (Hgb) < 8.5 g/dL
- Platelet count < 75,000 /mm^3
- PT or PTT > 1.5 x ULN (if patients on anticoagulants: PT INR > 3.5 x ULN)
Inadequate renal and liver function as indicated by:
- Albumin < 2.8 g/dL
- Total bilirubin > 1.5 x ULN (or > 2.5 x ULN for patients with Gilbert's syndrome)
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase > 2 x ULN
- Creatinine > 2 x ULN
- Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle Gel
|
The vehicle gel contains no acetylated natural nucleotides but with the same base as study drug.
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Experimental: Gel containing Acetylated Natural Nucleotides
|
The study drug is a gel containing acetylated natural nucleotides.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients who achieve "NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE)" grade 0 or 1
Time Frame: 6 weeks
|
The proportion of patients who achieve "NCI CTCAE v5.0 - PPE" grade 0 or 1 at week 6 from grade 2 or above at baseline
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety of study drug
Time Frame: 6 weeks
|
Safety of study drug as determined by number of participants with abnormal laboratory values and/or Adverse Events that are related to treatment
|
6 weeks
|
Proportion of patients who achieve at least one grade improvement in HFS severity
Time Frame: 6 weeks
|
The proportion of patients who achieve at least one grade improvement in HFS severity according to "NCI CTCAE v5.0 - PPE" by week 6
|
6 weeks
|
Change from baseline in patient reported pain using Visual Analog Scale (VAS)
Time Frame: 6 weeks
|
Change from baseline in patient reported pain using VAS at week 6.
VAS is a scale used to determine the pain intensity experienced by individuals, which consists of a line 10 cm in length, with the left side signifying no pain and the right side signifying the worst pain ever.
|
6 weeks
|
Change from baseline in Hand-Foot Skin Reaction and Quality of Life (HF-QoL) Questionnaire total score
Time Frame: 6 weeks
|
Change from baseline in HF-QoL Questionnaire total score at week 6.
HF-QoL questionnaire is comprised of a 20-item symptom domain and an 18-item daily activity domain.
Each item is rated on a 5-point scale from 0 (not at all) to 4 (always or extremely) during the previous week.
The HF-QoL symptom and daily activity total scores are transformed to a scale of 0 to 100, based on the sum of each unit-weighted item score divided by the maximum score.
Higher scores on the HF-QoL indicate worse quality of life or greater symptom burden.
|
6 weeks
|
The proportion of patients whose anti-cancer medications are impacted due to HFS
Time Frame: 6 weeks
|
The proportion of patients who need temporary interruption or permanent discontinuation and/or dose reduction of anti-cancer medications due to HFS
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nan Xu, M.D., Shanghai East Hospital
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 (Actual)
November 3, 2020
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
June 1, 2022
Study Registration Dates
First Submitted
October 9, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 19, 2020
Study Record Updates
Last Update Posted (Actual)
March 1, 2023
Last Update Submitted That Met QC Criteria
February 27, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEH001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Hand-foot Syndrome
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Universitas SriwijayaActive, not recruitingCapecitabine | Hand and Foot Syndrome | Hand and Foot Skin ReactionIndonesia
-
China-Japan Friendship HospitalCompleted
-
Jessa HospitalHasselt UniversityRecruitingHand-foot Syndrome | Hand-foot Skin ReactionBelgium
-
Quanta MedicalNAOS Institute of Life ScienceCompletedGrade 2 Hand-foot SyndromFrance
-
Northwestern UniversityCompletedHand Foot Skin ReactionUnited States
-
China Medical University HospitalNot yet recruiting
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRecruitingHand-foot SyndromeChina
-
Instituto Brasileiro de Controle do CancerWecare Comércio de CosméticosRecruiting
-
Heinrich-Heine University, DuesseldorfTerminatedThe Effect of Topical Brimonidine Tartrate on Hand-foot Syndrome (HFS) in Cancer Patients (BRIMOCAN)Hand-foot SyndromeGermany
-
Mahidol UniversitySiriraj HospitalRecruiting
Clinical Trials on Gel containing Acetylated Natural Nucleotides
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NestléCompletedGastrointestinal CancerFrance
-
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-
Ohio State UniversityNational Cancer Institute (NCI); University of North Carolina, Chapel Hill; University...CompletedIntraepithelial Neoplasia | Squamous Cell Carcinoma of MouthUnited States
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-
Cairo UniversityUnknown
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI)WithdrawnHuman Papillomavirus Infection | Healthy SubjectUnited States
-
Chulalongkorn UniversityUnknown
-
Tianjin Medical University Cancer Institute and...Unknown
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University of PalermoUniversity of CataniaCompleted