An interventional study of Gel containing Acetylated Natural Nucleotides and Vehicle Gel in Hand-foot Syndrome, sponsored by Nan xu. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Nan xu · Not applicable, Interventional, and Treatment
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).
45 studies on the registry are indexed under Hand-Foot Syndrome; 9 are open to participants now.
This study's enrollment of 21 is below the median of 60 across 36 interventional studies indexed under Hand-Foot Syndrome.
Browse Hand-Foot Syndrome studies →This is the only study on the registry with Nan xu as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Significantly abnormal lab test:
Inadequate hematologic function as indicated by:
Inadequate renal and liver function as indicated by:
Drug: Gel containing Acetylated Natural Nucleotides
Drug: Vehicle Gel
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.
Proportion of patients who achieve "NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE)" grade 0 or 1
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
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
Proportion of patients who achieve at least one grade improvement in HFS severity
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 Visual Analog Scale (VAS)
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 Hand-Foot Skin Reaction and Quality of Life (HF-QoL) Questionnaire total score
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 whose anti-cancer medications are impacted due to HFS
The proportion of patients who need temporary interruption or permanent discontinuation and/or dose reduction of anti-cancer medications due to HFS
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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