---
title: Acetylated Natural Nucleotides in Treating Hand-foot Syndrome
nct_id: NCT04592731
overall_status: COMPLETED
phase: NA
sponsor: Nan xu
study_type: INTERVENTIONAL
primary_condition: Hand-foot Syndrome
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04592731.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04592731"
ct_last_update_post_date: 2023-03-01
last_seen_at: "2026-05-12T07:10:36.584Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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)

**NCT ID:** [NCT04592731](https://clinicaltrials.gov/study/NCT04592731)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 21
- **Lead Sponsor:** Nan xu
- **Conditions:** Hand-foot Syndrome
- **Start Date:** 2020-11-03
- **Completion Date:** 2022-06-01
- **CT.gov Last Update:** 2023-03-01

## 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Gel containing Acetylated Natural Nucleotides** (EXPERIMENTAL)
- **Vehicle Gel** (PLACEBO_COMPARATOR)

## Interventions

- **Gel containing Acetylated Natural Nucleotides** (DRUG) — The study drug is a gel containing acetylated natural nucleotides.
- **Vehicle Gel** (DRUG) — The vehicle gel contains no acetylated natural nucleotides but with the same base as study drug.

## Primary Outcomes

- **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

## Secondary Outcomes

- **Safety of study drug** _(time frame: 6 weeks)_
- **Proportion of patients who achieve at least one grade improvement in HFS severity** _(time frame: 6 weeks)_
- **Change from baseline in patient reported pain using Visual Analog Scale (VAS)** _(time frame: 6 weeks)_
- **Change from baseline in Hand-Foot Skin Reaction and Quality of Life (HF-QoL) Questionnaire total score** _(time frame: 6 weeks)_
- **The proportion of patients whose anti-cancer medications are impacted due to HFS** _(time frame: 6 weeks)_

## Locations (1)

- Shanghai East Hospital, Shanghai, Shanghai Municipality, China

## Recent Field Changes (last 30 days)

- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.shanghai east hospital|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04592731*  
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