Clinical trial NCT04592731: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hand-foot Syndrome
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Proportion of patients who achieve "NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE)" grade 0 or 1
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety of study drug
timeFrame: 6 weeks
measure: Proportion of patients who achieve at least one grade improvement in HFS severity
timeFrame: 6 weeks
measure: Change from baseline in patient reported pain using Visual Analog Scale (VAS)
timeFrame: 6 weeks
measure: Change from baseline in Hand-Foot Skin Reaction and Quality of Life (HF-QoL) Questionnaire total score
timeFrame: 6 weeks
measure: The proportion of patients whose anti-cancer medications are impacted due to HFS
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
Study officials:
affiliation: Shanghai East Hospital
name: Nan Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: