Palmar-Plantar ErythrodysesthesiaHFSB6NCT02625415
The Topical Application of Vitamin B6 in Palmar-Plantar Erythrodysesthesia
A study testing Vitamin B6 cream in people with Palmar-Plantar Erythrodysesthesia, run by Cyprus University of Technology at 2 sites in Cyprus.
Trial summary
The study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmar-Plantar Erythrodysesthesia
- What is being tested?
- Vitamin B6 cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesCyprus
- Study dates
- Jul 2016to 15 Jun 2018
- 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
- Adult cancer patients (>18)
- Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents
- Patients that will experience PPE grade 1 or above
- Willing to participate
- Ability to complete the psychometric assessments.
- A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG
Who cannot join
- Patients with hypersensitivity to Vitamin B.
- Patients with pre-existing dermatological condition affecting the hands or/and feet that may limit the interpretation of results
- Patients on oral Pyridoxine or nicotine patches
- Patients with a previous history of PPE
- Patients whose chemotherapy was discontinued for more than a week
Trial locations and contacts
2 sites in 1 country.
Cyprus2 sites
Limassol General Hospital
Limassol
American Medical Center
Nicosia, 1311
About this study
Official title: A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome
The study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).
Read the detailed description
This will be a randomized double-blind, placebo-controlled study with 100 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered daily (t.d.s) and assessments will take place at 0, 1, 2, 3 and 4 weeks.
The intervention group will receive the application of topical vitamin B6 cream to the hands and/or feet of the patients and the control group will receive the placebo.
At both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.
- Conditions
- Palmar-Plantar Erythrodysesthesia
- Being tested
- Vitamin B6 cream, Placebo Vitamin B6 cream
- 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.
Vitamin B6 creamDevice
Topical Vitamin B6 cream
Placebo Vitamin B6 creamDevice
Placebo Vitamin B6 cream
| Study group | Role | What they receive |
|---|---|---|
| Vitamin B6 | Experimental | Topical application of B6 cream to the hand or/and feet 1-2 ml applied to the hand or /and feet three times a day for 4 weeks. Receives: Device: Vitamin B6 cream |
| Placebo | Placebo comparator | Topical application of B6 Placebo cream to the hand or/and feet 1-2 ml applied to the hand or /and feet three times a day for 4 weeks. Receives: Device: Placebo Vitamin B6 cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
PPE grade
The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials (Scheithauer et al 2003)
Measured: up to 4 weeks
Secondary outcomes (2)
Health Related Quality of Life
The HRQoL of the patients will be assessed with the EORTC QLQ -C30 module which has been developed and validated explicitly for patients suffering from cancer.
Measured: up to 4 weeks
Quality of Life in relation to PPE
This is a quality of life scale specifically for patients experiencing radiation-induced PPE
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startJul 2016
- Primary completion1 May 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Palmar-Plantar ErythrodysesthesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- American Medical Center
- Responsible party
- Principal investigator, Dr. Andreas Charalambous, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02625415
- Sponsor's protocol ID
- AC-PPEHP-89
- Acronym
- HFSB6
- Status last verified
- Aug 2018
- First submitted
- 5 Dec 2015
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Charalambous A, Tsitsi T, Astras G, Paikousis L, Filippou E. A pilot randomized double-blind, placebo-controlled study on the effects of the topical application of pyridoxine on palmar-plantar erythrodysesthesia (PPE) induced by capecitabine or pegylated liposomal doxorubicin (PLD). Eur J Oncol Nurs. 2021 Feb;50:101866. doi: 10.1016/j.ejon.2020.101866. Epub 2020 Nov 11.
PubMed 33227569
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Placebo Control Randomised Trial to Test the Effectiveness of Vitamin B6 in Hand Foot Syndrome
- ClinicalTrials.gov ID
- NCT02625415
- Acronym / sponsor ID
- HFSB6 / AC-PPEHP-89
- Conditions
- Palmar-Plantar Erythrodysesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Collaborators
- American Medical Center
- Study start
- Jul 2016
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 9 Dec 2015 (estimated)
- 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 study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).
Detailed description
This will be a randomized double-blind, placebo-controlled study with 100 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered daily (t.d.s) and assessments will take place at 0, 1, 2, 3 and 4 weeks.
The intervention group will receive the application of topical vitamin B6 cream to the hands and/or feet of the patients and the control group will receive the placebo.
At both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin B6 | Experimental | Device: Vitamin B6 creamTopical application of B6 cream to the hand or/and feet 1-2 ml applied to the hand or /and feet three times a day for 4 weeks. |
| Placebo | Placebo comparator | Device: Placebo Vitamin B6 creamTopical application of B6 Placebo cream to the hand or/and feet 1-2 ml applied to the hand or /and feet three times a day for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult cancer patients (>18)
- Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents
- Patients that will experience PPE grade 1 or above
- Willing to participate
- Ability to complete the psychometric assessments.
Key exclusion criteria (5 listed)
- Patients with hypersensitivity to Vitamin B.
- Patients with pre-existing dermatological condition affecting the hands or/and feet that may limit the interpretation of results
- Patients on oral Pyridoxine or nicotine patches
- Patients with a previous history of PPE
- Patients whose chemotherapy was discontinued for more than a week
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 |
|---|---|---|
| Vitamin B6 creamTopical Vitamin B6 cream | Device | Vitamin B6 |
| Placebo Vitamin B6 creamPlacebo Vitamin B6 cream | Device | Placebo |
Primary outcome
PPE grade
Time frame: up to 4 weeks
The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials (Scheithauer et al 2003)
2 secondary outcomes
Health Related Quality of Life
Time frame: up to 4 weeks
Quality of Life in relation to PPE
Time frame: up to 4 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 7 Aug 2018.
- Derived from this study: PubMed 33227569Charalambous A, Tsitsi T, Astras G, Paikousis L, Filippou E. A pilot randomized double-blind, placebo-controlled study on the effects of the topical application of pyridoxine on palmar-plantar erythrodysesthesia (PPE) induced by capecitabine or pegylated liposomal doxorubicin (PLD). Eur J Oncol Nurs. 2021 Feb;50:101866. doi: 10.1016/j.ejon.2020.101866. Epub 2020 Nov 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B6 cream in people with Palmar-Plantar Erythrodysesthesia, run by Cyprus University of Technology at 2 sites in Cyprus.
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 6 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: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cyprus. 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?
PPE grade (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02625415, which also lists 1 linked publication.
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 7 Aug 2018.