Hand-foot SyndromePhase 2TACX CareNCT04833998
Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine
A Phase 2 study testing Extremecare in people with Hand-foot Syndrome, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
Trial summary
Hand-foot syndrome (HFS) is a very common adverse event of many chemotherapeutic agents, especially capecitabine. The HFS can considerably interfere patient quality of life (QoL). The current treatments for hand-foot symptoms no have demonstrated 100% efficacy. 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?
- Extremecare
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Aug 2019to 31 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age
- Patients with gastrointestinal tumors or breast cancer who will be treated with capecitabine
- Indication of adjuvant or palliative treatment with capecitabine
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Information of the patient and signature of the informed consent form by the patient or her legal representative.
Who cannot join
- Previous chemotherapy with capecitabine
- Pre-existing patients with neuropathies
- Patients with known allergic reactions to any of the ingredients of the investigational product
- Patients with dermatological conditions that affect the hands or feet
- Patients with rectal neoplasia and indication for neoadjuvant treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
IBCC Oncologia
São Paulo, 03102002
Flávia Viécili Tarcha, MD, +55 11 99700-0316, flavinhavt@yahoo.com
Alayne Domingues Yamada, PhD, +55 11 98141-7613, alayne.pesquisa@ibcc-mooca.org.br
About this study
Official title: Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine: TACX Care Trial
Hand-foot syndrome (HFS) is a very common adverse event of many chemotherapeutic agents, especially capecitabine. The HFS can considerably interfere patient quality of life (QoL).
The current treatments for hand-foot symptoms no have demonstrated 100% efficacy. And, the dose reduction and treatment interruption are recommended for treatment of HFS.
Read more
It is known that hydration improves the degree of hand-foot syndrome, as it improves moisture retention and maintain hydration, thereby reducing further desquamation and decreasing infection risks. But so far there is no evidence of a cream that improves incidence. Besides that, clinical trials evaluating the use of urea-based moisturizer in patients treated with capecitabine have not shown efficacy in preventing hand-foot syndrome.
The purpose of this study is to evaluate the effectiveness of moisturizer based on Thoitaine, Aloe Vera and Calendula compared to placebo in the prevention of SMP of any degree, in patients using Capecitabine.
Read the detailed description
The research product, proposed in this study, was developed to meet the specific hydration needs of patients undergoing cancer treatment and is produced from nine main ingredients with natural moisturizing actions based on glycerin, hazelnut extract, shea butter, aloe vera, calendula, chamomile and oat extract and 2 antioxidants (vitamin E and Thoitaine), dermatologically tested and approved. The choice of the product was based, mainly, due to its natural components, whose data from previous studies were extrapolated from radiodermatitis.
- Conditions
- Hand-foot Syndrome
- Being tested
- Extremecare, Placebo
- Keywords
- Hand-foot Syndrome, Palmoplantar Erythrodysesthesia, Acral Erythema, Capecitabine, Moisturizing 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.
ExtremecareDrug
The product under investigation (Extremecare) will be supplied as 120g use individual tubes to be applicated in the hands and feet twice a day (once in the morning and once in the evening) beginning with the first cycle of capecitabine and continuing until the end of the fifth cycle of chemotherapy.
PlaceboDrug
Placebo cream will be supplied as 120g use individual tubes to be applicated in the hand and feet twice a day (once in the morning and once in the evening) during the fifth cycle of capecitabine therapy.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo will be cream without the active ingredient. It will be matched in appearance, smell, consistency, and color to Extremecare topical cream. Patients will be instructed to apply the placebo cream to the hand and feet. Receives: Drug: Placebo |
| Extremecare | Experimental | Extremecare is a moisturizing cream based on Thoitaine, Aloe Vera and Calendula for topical use. Patients will be instructed to apply the moisturizing cream to the hand and feet. Receives: Drug: Extremecare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients presenting Hand-foot Syndrome (HFS) any grade secondary to capecitabine therapy.
Number of Patients who developed Hand-foot Syndrome (HFS) by Toxicity Grade. The incidence and severity of hand-foot syndrome (HFS) developed during chemotherapy will be defined by using the grading system for HFS per the NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 for all patients assigned who received at least 1 cycle of capecitabine. Investigators assess and fill the grading into the case report form every visit.
Measured: Up to 15 weeks
Secondary outcomes (4)
Changes in the signs of hand-foot syndrome
Digital Photos will be taken of the hands and feet at 21 day intervals until the fifth cycles of capecitabine-containing chemotherapy ended to evaluate Erythema, desquamation, edema, ulceration, vesicopustules.
Measured: Baseline and 1-2-3-4-5 cycles of capecitabine-containing chemotherapy (each cycle is 21 days)
Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.
Determined by the number of patients who required a toxicity-related, dose reduction of capecitabine during active treatment at each cycle where a dose reduction occurred
Measured: Up to 15 weeks
Quality of Life as Measured by Dermatology Life Quality Index (DLQI)
Dermatology Life Quality Index (DLQI) consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much). The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. It is self explanatory and is usually completed in one or two minutes.
Measured: Up to 15 weeks
Incidence of cessation of capecitabine therapy
Cessation of capecitabine thereby because any toxicity
Measured: Up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start2 Aug 2019
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The allocation ratio is 2:1, favouring the active treatment. In this study we are using unequal allocation ratios for a variety of reasons, including allowance for learning curves, and ethical considerations when the balance of existing evidence appears to be in favour of one intervention over the placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Brasileiro de Controle do Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Wecare Comércio de Cosméticos
- Responsible party
- Principal investigator, Flavia Viecili Tarcha, Instituto Brasileiro de Controle do Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833998
- Sponsor's protocol ID
- 01629018.1.0000.0072
- Acronym
- TACX Care
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2021
- Last updated
- 6 Apr 2021
- 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 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine: TACX Care Trial
- ClinicalTrials.gov ID
- NCT04833998
- Acronym / sponsor ID
- TACX Care / 01629018.1.0000.0072
- Conditions
- Hand-foot Syndrome
- Keywords
- Hand-foot Syndrome, Palmoplantar Erythrodysesthesia, Acral Erythema, Capecitabine, Moisturizing cream
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Instituto Brasileiro de Controle do CancerUniversity, hospital or other
- Collaborators
- Wecare Comércio de Cosméticos
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 6 Apr 2021 (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 syndrome (HFS) is a very common adverse event of many chemotherapeutic agents, especially capecitabine. The HFS can considerably interfere patient quality of life (QoL).
The current treatments for hand-foot symptoms no have demonstrated 100% efficacy. And, the dose reduction and treatment interruption are recommended for treatment of HFS.
It is known that hydration improves the degree of hand-foot syndrome, as it improves moisture retention and maintain hydration, thereby reducing further desquamation and decreasing infection risks. But so far there is no evidence of a cream that improves incidence. Besides that, clinical trials evaluating the use of urea-based moisturizer in patients treated with capecitabine have not shown efficacy in preventing hand-foot syndrome.
The purpose of this study is to evaluate the effectiveness of moisturizer based on Thoitaine, Aloe Vera and Calendula compared to placebo in the prevention of SMP of any degree, in patients using Capecitabine.
Detailed description
The research product, proposed in this study, was developed to meet the specific hydration needs of patients undergoing cancer treatment and is produced from nine main ingredients with natural moisturizing actions based on glycerin, hazelnut extract, shea butter, aloe vera, calendula, chamomile and oat extract and 2 antioxidants (vitamin E and Thoitaine), dermatologically tested and approved. The choice of the product was based, mainly, due to its natural components, whose data from previous studies were extrapolated from radiodermatitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The allocation ratio is 2:1, favouring the active treatment. In this study we are using unequal allocation ratios for a variety of reasons, including allowance for learning curves, and ethical considerations when the balance of existing evidence appears to be in favour of one intervention over the placebo.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be cream without the active ingredient. It will be matched in appearance, smell, consistency, and color to Extremecare topical cream. Patients will be instructed to apply the placebo cream to the hand and feet. |
| Extremecare | Experimental | Drug: ExtremecareExtremecare is a moisturizing cream based on Thoitaine, Aloe Vera and Calendula for topical use. Patients will be instructed to apply the moisturizing cream to the hand and feet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 years of age
- Patients with gastrointestinal tumors or breast cancer who will be treated with capecitabine
- Indication of adjuvant or palliative treatment with capecitabine
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Information of the patient and signature of the informed consent form by the patient or her legal representative.
Key exclusion criteria (5 listed)
- Previous chemotherapy with capecitabine
- Pre-existing patients with neuropathies
- Patients with known allergic reactions to any of the ingredients of the investigational product
- Patients with dermatological conditions that affect the hands or feet
- Patients with rectal neoplasia and indication for neoadjuvant treatment.
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 |
|---|---|---|
| ExtremecareThe product under investigation (Extremecare) will be supplied as 120g use individual tubes to be applicated in the hands and feet twice a day (once in the morning and once in the evening) beginning with the first cycle of capecitabine and continuing until the end of the fifth cycle of chemotherapy. | Drug | Extremecare |
| PlaceboPlacebo cream will be supplied as 120g use individual tubes to be applicated in the hand and feet twice a day (once in the morning and once in the evening) during the fifth cycle of capecitabine therapy. | Drug | Placebo |
Primary outcome
Number of patients presenting Hand-foot Syndrome (HFS) any grade secondary to capecitabine therapy.
Time frame: Up to 15 weeks
Number of Patients who developed Hand-foot Syndrome (HFS) by Toxicity Grade. The incidence and severity of hand-foot syndrome (HFS) developed during chemotherapy will be defined by using the grading system for HFS per the NCI Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 for all patients assigned who received at least 1 cycle of capecitabine. Investigators assess and fill the grading into the case report form every visit.
4 secondary outcomes
Changes in the signs of hand-foot syndrome
Time frame: Baseline and 1-2-3-4-5 cycles of capecitabine-containing chemotherapy (each cycle is 21 days)
Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.
Time frame: Up to 15 weeks
Quality of Life as Measured by Dermatology Life Quality Index (DLQI)
Time frame: Up to 15 weeks
Incidence of cessation of capecitabine therapy
Time frame: Up to 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
Related trials for Hand-foot Syndrome
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
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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
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Active, not recruitingPhase 3
The Efficacy and Safety of Mecobalamin in the Prevention of Capecitabine Induced Hand Foot Syndrome
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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.
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 Extremecare in people with Hand-foot Syndrome, run by Instituto Brasileiro de Controle do Cancer at 1 site in Brazil.
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 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 6 Apr 2021. 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 Brazil. 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 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 Flavia Viécili Tarcha, MD (+55 11 99700-0316, flavinhavt@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients presenting Hand-foot Syndrome (HFS) any grade secondary to capecitabine therapy. (time frame: Up to 15 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 6 Apr 2021.