Acetylated Natural Nucleotides in Treating Hand-foot Syndrome

NCT04592731 | Completed

• 1 other identifier: SHEH001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Hand-foot Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Safety of study drug

  6 weeks

• Proportion of patients who achieve at least one grade improvement in HFS severity

  6 weeks

• Change from baseline in patient reported pain using Visual Analog Scale (VAS)

  6 weeks

• Change from baseline in Hand-Foot Skin Reaction and Quality of Life (HF-QoL) Questionnaire total score

  6 weeks

• The proportion of patients whose anti-cancer medications are impacted due to HFS

  6 weeks

Study Arms (2)

Gel containing Acetylated Natural Nucleotides

EXPERIMENTAL

Drug: Gel containing Acetylated Natural Nucleotides

Vehicle Gel

PLACEBO COMPARATOR

Drug: Vehicle Gel

Interventions

Gel containing Acetylated Natural Nucleotides DRUG

The study drug is a gel containing acetylated natural nucleotides.

Gel containing Acetylated Natural Nucleotides

Vehicle Gel DRUG

The vehicle gel contains no acetylated natural nucleotides but with the same base as study drug.

Vehicle Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nan xu: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Hand-Foot Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Nan Xu, M.D.

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Department Head in Dermatology

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: November 3, 2020
• Primary Completion: April 30, 2022
• Study Completion: June 1, 2022
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)