Acetylated Natural Nucleotides in Treating Hand-foot Syndrome

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: Hand-foot Syndrome
• Intervention / Treatment: Drug: Gel containing Acetylated Natural Nucleotides; Drug: Vehicle Gel

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Shanghai East Hospital

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle Gel	Drug: Vehicle Gel; The vehicle gel contains no acetylated natural nucleotides but with the same base as study drug.
Experimental: Gel containing Acetylated Natural Nucleotides	Drug: 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	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	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	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)	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	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	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

• Sponsor: Nan xu
• Investigators: Principal Investigator: Nan Xu, M.D., Shanghai East Hospital

Study record dates

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: Chemically-Induced Disorders; Pathologic Processes; Skin Diseases; Disease; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Drug Eruptions; Drug Hypersensitivity; Syndrome; Hand-Foot Syndrome
• 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