Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06441513

The Preventive Effect of Chemotherapy-induced Hand-foot Syndrome

Led by Peking University Third Hospital · Updated on 2024-06-04

130

Participants Needed

1

Research Sites

182 weeks

Total Duration

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AI-Summary

What this Trial Is About

this study will use traditional Chinese medicine bath with no obvious side effects combined with case tracking management mode to form nursing measures to prevent hand foot syndrome. A randomized controlled trial design will be used to collect cases of hand foot syndrome (HFS) that did not appear after chemotherapy in the ward of the Department of chemotherapy, Peking University Third Hospital, and carry out nursing intervention.

CONDITIONS

Official Title

The Preventive Effect of Chemotherapy-induced Hand-foot Syndrome

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • No symptoms of hand-foot syndrome in chemotherapy patients
  • Age between 18 and 65 years
  • Estimated survival of 3 months or more
  • No major organ dysfunction; heart, liver, and kidney functions basically normal
  • Laboratory values within specified limits: neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 90 g/L
  • Bilirubin normal or less than 1.5 times the upper limit of normal
  • AST and ALT less than 2.5 times the upper limit of normal
  • Serum creatinine less than 1.5 times the upper limit of normal
  • Endogenous creatinine clearance (CCR) 60 ml/min or higher
  • Able to understand the study and cooperate with HFS assessment
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • History of nerve trauma before chemotherapy, diabetic neuropathy, untreated spinal cord compression, spinal canal stenosis or nerve root compression, or central nervous system tumors
  • Presence of skin lesions on hands or feet
  • Planned use of other drugs affecting HFS (e.g., urea cream, vitamin B6, celecoxib, compound Sophora flavescens injection, calf blood deproteinized extract intravenous injection)
  • Severe, uncontrolled organic diseases or infections causing chemotherapy intolerance (e.g., decompensated heart, lung, or kidney failure)
  • Participation in other clinical trials currently or within the last 4 weeks
  • Significant neurological or psychiatric history affecting understanding or consent, including dementia or epilepsy
  • Allergy or intolerance to the traditional Chinese medicine used in this study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University Third Hospital

Beijing, Beijing Municipality, China

Actively Recruiting

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Research Team

Y

Yamei Chen

CONTACT

J

Jing Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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