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Completed

NCT Number: NCT04592731

Acetylated Natural Nucleotides in Treating Hand-foot Syndrome

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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

  1. Safety of study drug

    Time frame: 6 weeks

    Safety of study drug as determined by number of participants with abnormal laboratory values and/or Adverse Events that are related to treatment

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

    Time frame: 6 weeks

    The proportion of patients who achieve at least one grade improvement in HFS severity according to "NCI CTCAE v5.0 - PPE" by week 6

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

    Time frame: 6 weeks

    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.

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

    Time frame: 6 weeks

    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.

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

    Time frame: 6 weeks

    The proportion of patients who need temporary interruption or permanent discontinuation and/or dose reduction of anti-cancer medications due to HFS

Sponsors and collaborators

Lead sponsor

Nan xu

Other

Registry information

Official study title

A Clinical Trial to Evaluate the Efficacy and Safety of Acetylated Natural Nucleotides in Treating Hand-foot Syndrome (HFS)

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2020
Registry last updated
Mar 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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