Hand-Foot Skin Reaction (HFSR)Phase 2NCT04242927
A Study to Investigate Nicotinic Acid on VEGFR Inhibitor-Associated Hand-Foot Skin Reactions
A Phase 2 study testing Nicotinic acid +Routine care and Routine care in people with Hand-Foot Skin Reaction (HFSR), run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) in cancer patients. The main purpose of this study is to evaluate the efficacy and safety of nicotinic acid in solid tumor patients with grade II/III VEGFRi-associated HFSR. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hand-Foot Skin Reaction (HFSR)
- What is being tested?
- Nicotinic acid +Routine care and Routine care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2020to 9 Mar 2022
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to performing any protocol-related procedures, including blood serum collecting
- HFSR grade 2 or higher after treatment with VEGFR inhibitors (such as sorafenib, regorafenib, anlotinib, and apatinib), according to NCI CTCAE V5.0 - PPE
- Age from 18 to 75 years.
- Life expectancy of at least 3 months at Day 1
Who cannot join
- History of allergy to B vitamins
- Major surgery or severe traumatic injury, fracture within 4 weeks prior to first dose of nicotinic acid or ulceration and any factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction
- Patient who takes isoniazid in combination with sorafenib and other VEGFR inhibitors.
- History of psychiatric drugs substance abuse and fails to quit it or has amental disorder
- Pregnant or nursing women, fertile patient who is unwilling or unable to use effective contraception
Trial locations and contacts
1 site in 1 country.
Shenglin Ma, MD contact
China1 site, 1 recruiting
- Recruiting
First People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310006
Xueqin Chen, +8613735430109, chenlucy1437@aliyun.com
Xueqin Chen
About this study
Official title: Efficacy of Nicotinic Acid for VEGFR Inhibitor-Associated Hand-Foot Skin Reactions in Solid Tumor Patients: a Randomised Controlled Phase 2 Trial
Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) in cancer patients. The main purpose of this study is to evaluate the efficacy and safety of nicotinic acid in solid tumor patients with grade II/III VEGFRi-associated HFSR.
- Conditions
- Hand-Foot Skin Reaction (HFSR)
- Being tested
- Nicotinic acid +Routine care, Routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinic acid +Routine careDrug
Also called Nicotinic Acid 50 MG Oral Tablet
Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.
Routine careDrug
Also called Urea ointment
Routinely apply urea ointment and provide best supportive care.
| Study group | Role | What they receive |
|---|---|---|
| Nicotinic acid + Routine care | Experimental | Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care. Receives: Drug: Nicotinic acid +Routine care |
| Routine care | Active comparator | Routinely apply urea ointment and provide best supportive care. Receives: Drug: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of VEGFR inhibitor-associated hand-foot skin reaction
Proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE) grade 0/1 (enrolled grade 2 patients) or grade 0-2 (enrolled grade 3 patients).
Measured: 2 year
Complete response rate of VEGFR inhibitor-associated hand-foot skin reaction
Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0.
Measured: 2 year
Secondary outcomes (2)
Dose adjustment/withdrawal ratio
Proportion of patients who need dose adjustment or withdrawal of VEGFR inhibitors, such as sorafenib, regorafenib, anlotinib, and apatinib.
Measured: 2 year
Hand-Foot Reaction Quality of Life (HF-QoL)
Hand-Foot Reaction Quality of Life (HF-QoL) questionnaire, scoring results statistics. The HF-QoL symptom and daily activity total scores were transformed to a scale of 0 to 4, 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 greatersymptom burden.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start9 Mar 2020
- Primary completion9 Mar 2021 (estimated)
- Study completion9 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand-Foot Skin Reaction (HFSR)Studies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Shenglin Ma, MD, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242927
- Sponsor's protocol ID
- NAVI
- Status last verified
- Mar 2020
- First submitted
- 23 Jan 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Nicotinic Acid for VEGFR Inhibitor-Associated Hand-Foot Skin Reactions in Solid Tumor Patients: a Randomised Controlled Phase 2 Trial
- ClinicalTrials.gov ID
- NCT04242927
- Acronym / sponsor ID
- NAVI
- Conditions
- Hand-Foot Skin Reaction (HFSR)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Collaborators
- Zhejiang University
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 9 Mar 2021 (estimated)
- Study completion
- 9 Mar 2022 (estimated)
- First posted
- 27 Jan 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.
Hand-Foot Skin Reaction (HFSR) is a common adverse event induced by Vascular Endothelial Growth Receptor Inhibitor (VEGFRi) in cancer patients. The main purpose of this study is to evaluate the efficacy and safety of nicotinic acid in solid tumor patients with grade II/III VEGFRi-associated HFSR.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotinic acid + Routine care | Experimental | Drug: Nicotinic acid +Routine careNicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care. |
| Routine care | Active comparator | Drug: Routine careRoutinely apply urea ointment and provide best supportive care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent obtained prior to performing any protocol-related procedures, including blood serum collecting
- HFSR grade 2 or higher after treatment with VEGFR inhibitors (such as sorafenib, regorafenib, anlotinib, and apatinib), according to NCI CTCAE V5.0 - PPE
- Age from 18 to 75 years.
- Life expectancy of at least 3 months at Day 1
Key exclusion criteria (5 listed)
- History of allergy to B vitamins
- Major surgery or severe traumatic injury, fracture within 4 weeks prior to first dose of nicotinic acid or ulceration and any factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction
- Patient who takes isoniazid in combination with sorafenib and other VEGFR inhibitors.
- History of psychiatric drugs substance abuse and fails to quit it or has amental disorder
- Pregnant or nursing women, fertile patient who is unwilling or unable to use effective contraception
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 |
|---|---|---|
| Nicotinic acid +Routine careAlso: Nicotinic Acid 50 MG Oral TabletNicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care. | Drug | Nicotinic acid + Routine care |
| Routine careAlso: Urea ointmentRoutinely apply urea ointment and provide best supportive care. | Drug | Routine care |
Primary outcome
Response rate of VEGFR inhibitor-associated hand-foot skin reaction
Time frame: 2 year
Proportion of patients who achieve NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE) grade 0/1 (enrolled grade 2 patients) or grade 0-2 (enrolled grade 3 patients).
Complete response rate of VEGFR inhibitor-associated hand-foot skin reaction
Time frame: 2 year
Proportion of patients who achieve NCI CTCAE v5.0 - PPE grade 0.
2 secondary outcomes
Dose adjustment/withdrawal ratio
Time frame: 2 year
Hand-Foot Reaction Quality of Life (HF-QoL)
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
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.
Shenglin Ma, MD contact
Shenglin Ma, MD principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nicotinic acid +Routine care and Routine care in people with Hand-Foot Skin Reaction (HFSR), run by First People's Hospital of Hangzhou 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Apr 2020. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xueqin Chen, MD (+8613735430109, chenlucy1437@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of VEGFR inhibitor-associated hand-foot skin reaction (time frame: 2 year). The study lists 2 primary outcomes in all. 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 Apr 2020.