Hand-foot SyndromeNCT04592731
Acetylated Natural Nucleotides in Treating Hand-foot Syndrome
A study testing Gel containing Acetylated Natural Nucleotides in people with Hand-foot Syndrome, run by Nan xu at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand-foot Syndrome
- What is being tested?
- Gel containing Acetylated Natural Nucleotides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2020to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Trial to Evaluate the Efficacy and Safety of Acetylated Natural Nucleotides in Treating Hand-foot Syndrome (HFS)
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).
- Conditions
- Hand-foot Syndrome
- Being tested
- Gel containing Acetylated Natural Nucleotides, Vehicle Gel
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel containing Acetylated Natural NucleotidesDrug
The study drug is a gel containing acetylated natural nucleotides.
Vehicle GelDrug
The vehicle gel contains no acetylated natural nucleotides but with the same base as study drug.
| Study group | Role | What they receive |
|---|---|---|
| Gel containing Acetylated Natural Nucleotides | Experimental | Not described Receives: Drug: Gel containing Acetylated Natural Nucleotides |
| Vehicle Gel | Placebo comparator | Not described Receives: Drug: Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start3 Nov 2020
- Primary completion30 Apr 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand-foot SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nan xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nan xu, Shanghai East Hospital
- Investigators
- Nan Xu, M.D., Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592731
- Sponsor's protocol ID
- SHEH001
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Efficacy and Safety of Acetylated Natural Nucleotides in Treating Hand-foot Syndrome (HFS)
- ClinicalTrials.gov ID
- NCT04592731
- Acronym / sponsor ID
- SHEH001
- Conditions
- Hand-foot Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nan xuUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gel containing Acetylated Natural Nucleotides | Experimental | Drug: Gel containing Acetylated Natural Nucleotides |
| Vehicle Gel | Placebo comparator | Drug: Vehicle Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gel containing Acetylated Natural NucleotidesThe study drug is a gel containing acetylated natural nucleotides. | Drug | Gel containing Acetylated Natural Nucleotides |
| Vehicle GelThe vehicle gel contains no acetylated natural nucleotides but with the same base as study drug. | Drug | Vehicle Gel |
Primary outcome
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
5 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Hand-foot Syndrome
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
Palmar and Plantar Erythema, Numbness of the Four Limbs
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SHIELD: Sorafenib Hand-foot Syndrome Inhibition With Pre-Emptive Local Delivery of Topical Indomethacin
Hepato Cellular Carcinoma (HCC), Hand Foot Skin Syndrome
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Clinical Trial Evaluating the Efficacy and Safety of Uracil 0,5% Plasters in Oncology Patients Affected by Hand-foot Syndrome (HFS)
HFS
Not yet recruitingPhase 2
TAR-0520 Gel in Hand and Foot Syndrome
Hand and Foot Syndrome
Active, not recruitingPhase 3
The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome
Hand-foot Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nan Xu, M.D. principal investigator
Shanghai East Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel containing Acetylated Natural Nucleotides in people with Hand-foot Syndrome, run by Nan xu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who achieve "NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE)" grade 0 or 1 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.