Grade 2 Hand-foot SyndromPhase 3OCRPNCT03612011
Efficacy of the Cosmetic Product "Onco-Repair" on Grade 2 Hand Foot Syndrome
A Phase 3 study of Grade 2 Hand-foot Syndrom, run by Quanta Medical at 1 site in France.
Trial summary
The aim of the study is to assess the restorative efficacy of the cosmetic product "Onco-Repair" vs placebo of the most affected palmer face in subject with grade 2 HFS induced by targeted therapies or conventional chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grade 2 Hand-foot Syndrom
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2018to 2 Jun 2019
- Phase
- Phase 3
- 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
- Who suffers from grade 2 HFS
- Subject under anti-tumor treatment known to cause this toxicity: targeted therapies or conventional chemotherapy: 5-Fluorouracile, Aflibercept, Axitinib, Bévacizumab, Capécitabine, Cediranib, Cytarabine, Dabrafenib, Docétaxel, Doxorubicine, Epirubicine, Pazopanib, Sorafenib, Sunitinib, Trastuzumab, Regorafenib, Vemurafenib and any other anti-tumor treatment that may lead to this toxicity
- Subject 18 years old and more
- Subject having been informed, having signed a free, informed and written consent
- Woman of childbearing age using contraception deemed effective
- Non-Inclusion Criteria:
Show all 16Show fewer
- Pregnant or lactating women
- Subject having a history of allergic contact dermatitis or irritation to any of the components of the investigational products
- Subjects with another skin pathology that may interfere with the evaluation of a HFS (at the investigator's discretion)
- Subject under anti-inflammatory treatment
- Subject participating in another clinical study during the duration of the study, except in a study assessing one of the molecules listed in the section above
- Subject who has already been treated for Grade 2 HFS or under other local treatment or cosmetic product
- Subject refusing to interrupt the application of his/her usual care
- Subject having a strongly altered general condition and / or non-autonomous subject (Karnofsky index <50%)
- Subject in linguistic or psychic impossibility to understand and sign informed consent or in the impossibility of submitting to the medical follow-up of the study
- Subject deprived of liberty by administrative or judicial decision, or under guardianship
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Restorative Efficacy of the Cosmetic Product "Onco-Repair" vs. Placebo on Grade 2 Hand Foot Syndrome Induced by Targeted Therapies or Conventional Chemotherapy. Randomized, Multicentre, Double Blind, Controlled Study Versus Placebo.
The aim of the study is to assess the restorative efficacy of the cosmetic product "Onco-Repair" vs placebo of the most affected palmer face in subject with grade 2 HFS induced by targeted therapies or conventional chemotherapy.
Read the detailed description
HFS, also known as Palmar-Plantar Erythrodysethesia, is a common adverse event observed in subjects under anti-tumor therapy with conventional chemotherapy or targeted thérapies. The initial symptoms are dysesthesia and tingling in the palms, fingers and soles of feet and erythema, which may progress to burning pain with dryness, cracking, desquamation, ulceration and oedema. Sensory impairment, paresthesia and pruritus have also been reported. Palms of the hands are more frequently affected than soles of the feet, and might even be the only area affected in some subjects.
Although HFS is rarely life-threatening, the skin changes are often painful and debilitating and can impair with the general activities of daily living and quality of life. No standard prevention for HFS has not been established yet.
Onco-Repair is a nourishing and repairing cream specially formulated to treat grade 2 HFS which demonstrate skin tolerance, hypoallergenicity and efficacy through several preclinical and clinical studies on healthy subjects.
Therefore, a randomized, double-blind, placebo-controlled study will be conducted to evaluate efficacy and safety of topical cream 'Onco-Repair' on HFS.
- Conditions
- Grade 2 Hand-foot Syndrom
- Being tested
- Onco-Repair/ Placebo
- Keywords
- Hand Foot Syndrome Grade 2, Common Terminology Criteria for Adverse Events (CTCAE), Oncology, Repair Cream, Cutaneous events, Palmar-plantar erythrodysesthesia syndrome, Targeted Therapies or Conventional Chemotherapy
- Medical subject headings
- Neoplasms, Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onco-Repair/ PlaceboOther
Cream must be applied twice a day, in the morning and evening, on the hands and feet (palmo-plantar areas and interdigital spaces included) previously cleaned with Atoderm Intensive Foaming Gel, chosen as a standardized hygiene product.
| Study group | Role | What they receive |
|---|---|---|
| Onco-Repair | Experimental | Onco-Repair tube of 150 ml Receives: Other: Onco-Repair/ Placebo |
| Placebo | Placebo comparator | Placebo tube of 150 ml Receives: Other: Onco-Repair/ Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall success
A subject is considered to have attained success if he achieves at least one grade improvement in HFS for the most affected palmer face according to the National Cancer Institute CTCATE V5.0 at any time during study period (28 days).
The subjects will be defined in success or failure according to the following rules:
Success: switch from grade 2 to grade 1 or grade 0 Failure: switch from grade 2 to grade 3 If subjects remain at grade 2 at the end of the study, they will be classified as either success or failure according to the evolution of clinical signs and / or quality of life assessed using the Dermatological Life Quality Index (DLQI) scale from D0 to D28.
Measured: 28 days
Secondary outcomes (14)
Time to onset of grade 1 or 0 will be assessed using time (in days) from study commencement (inclusion, D0) to first occurrence of grade 1 or lower HFS according to the CTCAEV5.0
Time to onset of grade 1 or 0 will be assessed using time (in days) from study
Measured: 28 days
Clinical parameters such as lesion color
Clinical parameters such as lesion color will be assessed
- On e-CRF at D0, D7 and D28
- from D0 to D28 using a standardized diary completed by subjects
Measured: Day 0 (inclusion) , Day 7 and Day 28
Clinical parameters such as presence of blisters
Clinical parameters such as presence of blisters will be assessed
- On e-CRF at D0, D7 and D28
- from D0 to D28 using a standardized diary completed by subjects
Measured: Day 0 (inclusion) , Day 7 and Day 28
Clinical parameters such as fissures/cracks
Clinical parameters such as fissures/cracks will be assessed
- On e-CRF at D0, D7 and D28
- from D0 to D28 using a standardized diary completed by subjects
Measured: Day 0 (inclusion) , Day 7 and Day 28
Assessment of quality of life from D0 to D28 using Dermatology Life Quality Index scale
Quality of life will be assessed from D0 to D28 using Dermatology Life Quality Index scale. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages.
Meaning of Dermatology Life Quality Index scale Scores:
0 to 1 = no effect at all on patient's life 2 to 5 = small effect on patient's life 6 to 10 = moderate effect on patient's life 11 to 20 = very large effect on patient's life 21 to 30 = extremely large effect on patient's life
Measured: 28 days
Assessment of symptoms
Such as intensity of lesions, feeling of subjects, etc will be assessed: on e-CRF at D0, D7 and D28, from D0 to D28 using a standardized diary completed by subjects
Measured: Day 0 (inclusion) , Day 7 and Day 28
Assessment of pain score and prurit at D0, D7 and D28 using a 100 Visual Analogue Scale [Visual analogue scale, 0 (no pain, no prurit) and 100 (worst possible pain or prurit)]
Pain score and prurit will be assessed at D0, D7 and D28 using a 100 Visual Analogue Scale [Visual analogue scale , 0 (no pain, no prurit) and 100 (worst possible pain or prurit)]
Measured: Day 0 (inclusion) , Day 7 and Day 28
Assessment of the repair quality of skin
The repair quality of skin will be assessed from D0, D7 and D28 using a standardized diary completed by subjects.
Measured: Day 0 (inclusion) , Day 7 and Day 28
Cosmetic parameters such as nourishing power of the cream will be assessed at D28 using a standardized diary
Nourishing power will be assessed at D28 using a standardized diary completed by subjects.
Measured: 28 days
Cosmetic parameters such as soothing power of the cream will be assessed at D28 using a standardized diary
Soothing power will be assessed at D28 using a standardized diary completed by subjects.
Measured: 28 days
Cosmetic parameters such as penetration power of the cream will be assessed at D28 using a standardized diary
Penetration power will be assessed at D28 using a standardized diary completed by subjects.
Measured: 28 days
Assessment of compliance
The compliance will be assessed at the end of the study: subject will be considered to be compliant if he/she applied at least the theoretical consumption of 60% of the product.
Measured: 28 days
The overall tolerance will be assessed by the investigator (Subject interrogation). This evaluation will be carried out during visits using the following rating: 1 = Very good tolerance 2 = Good tolerance 3 = Middle tolerance 4 = Poor tolerance
- = Very good tolerance: no functional signs of discomfort and no objective signs during examination
- = Good tolerance: some functional signs of minimal and transient discomfort that did not interrupt the applications and no objective signs during examination
- = Middle tolerance: functional signs of discomfort, net or persistent, or objective signs during examination that did not interrupt the applications of the investigationalproduct
- = Poor tolerance: functional and / or objectives signs leading to discontinuation of the use of the investigational product
Measured: 28 days
Safety will be will be evaluated in terms of: - the number of subjects presenting during the study period at least : One AE/ One SAE - the total number of AEs during the study period - the total number of SAEs during the study period
Safety will be assessed on the basis of adverse event (AE) reports
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start12 Jul 2018
- Primary completion1 Aug 2018
- Study completion2 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Grade 2 Hand-foot SyndromStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III multicenter, double blind, superiority, prospective, randomised controlled study Subjects will be randomized to receive either cosmetic product "Onco-Repair" or placebo in a 1:1 ratio
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quanta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAOS Institute of Life Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612011
- Sponsor's protocol ID
- NAOS_ONCOREPAIR_PP_17_2851
- Acronym
- OCRP
- Status last verified
- Sep 2019
- First submitted
- 12 Jul 2018
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lipworth AD, Robert C, Zhu AX. Hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia): focus on sorafenib and sunitinib. Oncology. 2009;77(5):257-71. doi: 10.1159/000258880. Epub 2009 Nov 16.
PubMed 19923864Zhang RX, Wu XJ, Lu SX, Pan ZZ, Wan DS, Chen G. The effect of COX-2 inhibitor on capecitabine-induced hand-foot syndrome in patients with stage II/III colorectal cancer: a phase II randomized prospective study. J Cancer Res Clin Oncol. 2011 Jun;137(6):953-7. doi: 10.1007/s00432-010-0958-9. Epub 2010 Nov 27.
PubMed 21113620
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Restorative Efficacy of the Cosmetic Product "Onco-Repair" vs. Placebo on Grade 2 Hand Foot Syndrome Induced by Targeted Therapies or Conventional Chemotherapy. Randomized, Multicentre, Double Blind, Controlled Study Versus Placebo.
- ClinicalTrials.gov ID
- NCT03612011
- Acronym / sponsor ID
- OCRP / NAOS_ONCOREPAIR_PP_17_2851
- Conditions
- Grade 2 Hand-foot Syndrom
- Keywords
- Hand Foot Syndrome Grade 2, Common Terminology Criteria for Adverse Events (CTCAE), Oncology, Repair Cream, Cutaneous events, Palmar-plantar erythrodysesthesia syndrome, Targeted Therapies or Conventional Chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Quanta MedicalIndustry (pharma, biotech, devices)
- Collaborators
- NAOS Institute of Life Science
- Study start
- 12 Jul 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 2 Jun 2019 (actual)
- First posted
- 2 Aug 2018 (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 aim of the study is to assess the restorative efficacy of the cosmetic product "Onco-Repair" vs placebo of the most affected palmer face in subject with grade 2 HFS induced by targeted therapies or conventional chemotherapy.
Detailed description
HFS, also known as Palmar-Plantar Erythrodysethesia, is a common adverse event observed in subjects under anti-tumor therapy with conventional chemotherapy or targeted thérapies. The initial symptoms are dysesthesia and tingling in the palms, fingers and soles of feet and erythema, which may progress to burning pain with dryness, cracking, desquamation, ulceration and oedema. Sensory impairment, paresthesia and pruritus have also been reported. Palms of the hands are more frequently affected than soles of the feet, and might even be the only area affected in some subjects.
Although HFS is rarely life-threatening, the skin changes are often painful and debilitating and can impair with the general activities of daily living and quality of life. No standard prevention for HFS has not been established yet.
Onco-Repair is a nourishing and repairing cream specially formulated to treat grade 2 HFS which demonstrate skin tolerance, hypoallergenicity and efficacy through several preclinical and clinical studies on healthy subjects.
Therefore, a randomized, double-blind, placebo-controlled study will be conducted to evaluate efficacy and safety of topical cream 'Onco-Repair' on HFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Phase III multicenter, double blind, superiority, prospective, randomised controlled study Subjects will be randomized to receive either cosmetic product "Onco-Repair" or placebo in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Onco-Repair | Experimental | Other: Onco-Repair/ PlaceboOnco-Repair tube of 150 ml |
| Placebo | Placebo comparator | Other: Onco-Repair/ PlaceboPlacebo tube of 150 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Who suffers from grade 2 HFS
- Subject under anti-tumor treatment known to cause this toxicity: targeted therapies or conventional chemotherapy: 5-Fluorouracile, Aflibercept, Axitinib, Bévacizumab, Capécitabine, Cediranib, Cytarabine, Dabrafenib, Docétaxel, Doxorubicine, Epirubicine, Pazopanib, Sorafenib, Sunitinib, Trastuzumab, Regorafenib, Vemurafenib and any other anti-tumor treatment that may lead to this toxicity
- Subject 18 years old and more
- Subject having been informed, having signed a free, informed and written consent
- Woman of childbearing age using contraception deemed effective
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Onco-Repair/ PlaceboCream must be applied twice a day, in the morning and evening, on the hands and feet (palmo-plantar areas and interdigital spaces included) previously cleaned with Atoderm Intensive Foaming Gel, chosen as a standardized hygiene product. | Other | Onco-Repair, Placebo |
Primary outcome
Overall success
Time frame: 28 days
A subject is considered to have attained success if he achieves at least one grade improvement in HFS for the most affected palmer face according to the National Cancer Institute CTCATE V5.0 at any time during study period (28 days). The subjects will be defined in success or failure according to the following rules: Success: switch from grade 2 to grade 1 or grade 0 Failure: switch from grade 2 to grade 3 If subjects remain at grade 2 at the end of the study, they will be classified as either success or failure according to the evolution of clinical signs and / or quality of life assessed using the Dermatological Life Quality Index (DLQI) scale from D0 to D28.
14 secondary outcomes
Time to onset of grade 1 or 0 will be assessed using time (in days) from study commencement (inclusion, D0) to first occurrence of grade 1 or lower HFS according to the CTCAEV5.0
Time frame: 28 days
Clinical parameters such as lesion color
Time frame: Day 0 (inclusion) , Day 7 and Day 28
Clinical parameters such as presence of blisters
Time frame: Day 0 (inclusion) , Day 7 and Day 28
Clinical parameters such as fissures/cracks
Time frame: Day 0 (inclusion) , Day 7 and Day 28
Assessment of quality of life from D0 to D28 using Dermatology Life Quality Index scale
Time frame: 28 days
Assessment of symptoms
Time frame: Day 0 (inclusion) , Day 7 and Day 28
Assessment of pain score and prurit at D0, D7 and D28 using a 100 Visual Analogue Scale [Visual analogue scale, 0 (no pain, no prurit) and 100 (worst possible pain or prurit)]
Time frame: Day 0 (inclusion) , Day 7 and Day 28
Assessment of the repair quality of skin
Time frame: Day 0 (inclusion) , Day 7 and Day 28
Cosmetic parameters such as nourishing power of the cream will be assessed at D28 using a standardized diary
Time frame: 28 days
Cosmetic parameters such as soothing power of the cream will be assessed at D28 using a standardized diary
Time frame: 28 days
Cosmetic parameters such as penetration power of the cream will be assessed at D28 using a standardized diary
Time frame: 28 days
Assessment of compliance
Time frame: 28 days
The overall tolerance will be assessed by the investigator (Subject interrogation). This evaluation will be carried out during visits using the following rating: 1 = Very good tolerance 2 = Good tolerance 3 = Middle tolerance 4 = Poor tolerance
Time frame: 28 days
Safety will be will be evaluated in terms of: - the number of subjects presenting during the study period at least : One AE/ One SAE - the total number of AEs during the study period - the total number of SAEs during the study period
Time frame: 28 days
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 6 Sep 2019.
- Background: PubMed 19923864Lipworth AD, Robert C, Zhu AX. Hand-foot syndrome (hand-foot skin reaction, palmar-plantar erythrodysesthesia): focus on sorafenib and sunitinib. Oncology. 2009;77(5):257-71. doi: 10.1159/000258880. Epub 2009 Nov 16.
- Background: PubMed 21113620Zhang RX, Wu XJ, Lu SX, Pan ZZ, Wan DS, Chen G. The effect of COX-2 inhibitor on capecitabine-induced hand-foot syndrome in patients with stage II/III colorectal cancer: a phase II randomized prospective study. J Cancer Res Clin Oncol. 2011 Jun;137(6):953-7. doi: 10.1007/s00432-010-0958-9. Epub 2010 Nov 27.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Grade 2 Hand-foot Syndrom, run by Quanta Medical at 1 site in France.
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 16 inclusion and 0 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 6 Sep 2019. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overall success (time frame: 28 days). 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 NCT03612011, which also lists 2 linked publications.
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 6 Sep 2019.