Back to resultsAcetylated Natural Nucleotides in Treating Hand-foot Syndrome
Primary Purpose
Hand-foot Syndrome
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Gel containing Acetylated Natural Nucleotides
Vehicle Gel
Sponsored by
About this trial
This is an interventional treatment trial for Hand-foot Syndrome
Eligibility Criteria
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.
Sites / Locations
- Shanghai East Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gel containing Acetylated Natural Nucleotides
Vehicle Gel
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients who achieve "NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE)" grade 0 or 1
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
Secondary Outcome Measures
Safety of study drug
Safety of study drug as determined by number of participants with abnormal laboratory values and/or Adverse Events that are related to treatment
Proportion of patients who achieve at least one grade improvement in HFS severity
The proportion of patients who achieve at least one grade improvement in HFS severity according to "NCI CTCAE v5.0 - PPE" by week 6
Change from baseline in patient reported pain using Visual Analog Scale (VAS)
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.
Change from baseline in Hand-Foot Skin Reaction and Quality of Life (HF-QoL) Questionnaire total score
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.
The proportion of patients whose anti-cancer medications are impacted due to HFS
The proportion of patients who need temporary interruption or permanent discontinuation and/or dose reduction of anti-cancer medications due to HFS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04592731
Brief Title
Acetylated Natural Nucleotides in Treating Hand-foot Syndrome
Official Title
A Clinical Trial to Evaluate the Efficacy and Safety of Acetylated Natural Nucleotides in Treating Hand-foot Syndrome (HFS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nan xu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand-foot Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gel containing Acetylated Natural Nucleotides
Arm Type
Experimental
Arm Title
Vehicle Gel
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Gel containing Acetylated Natural Nucleotides
Intervention Description
The study drug is a gel containing acetylated natural nucleotides.
Intervention Type
Drug
Intervention Name(s)
Vehicle Gel
Intervention Description
The vehicle gel contains no acetylated natural nucleotides but with the same base as study drug.
Primary Outcome Measure Information:
Title
Proportion of patients who achieve "NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE)" grade 0 or 1
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Safety of study drug
Description
Safety of study drug as determined by number of participants with abnormal laboratory values and/or Adverse Events that are related to treatment
Time Frame
6 weeks
Title
Proportion of patients who achieve at least one grade improvement in HFS severity
Description
The proportion of patients who achieve at least one grade improvement in HFS severity according to "NCI CTCAE v5.0 - PPE" by week 6
Time Frame
6 weeks
Title
Change from baseline in patient reported pain using Visual Analog Scale (VAS)
Description
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.
Time Frame
6 weeks
Title
Change from baseline in Hand-Foot Skin Reaction and Quality of Life (HF-QoL) Questionnaire total score
Description
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.
Time Frame
6 weeks
Title
The proportion of patients whose anti-cancer medications are impacted due to HFS
Description
The proportion of patients who need temporary interruption or permanent discontinuation and/or dose reduction of anti-cancer medications due to HFS
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Xu, M.D.
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Acetylated Natural Nucleotides in Treating Hand-foot Syndrome
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