Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120, China
NCT Number: NCT04592731
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200120, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The study drug is a gel containing acetylated natural nucleotides.
The vehicle gel contains no acetylated natural nucleotides but with the same base as study drug.
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
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
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
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.
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.
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
Nan xu
Other
A Clinical Trial to Evaluate the Efficacy and Safety of Acetylated Natural Nucleotides in Treating Hand-foot Syndrome (HFS)
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