DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCERAlantelNCT04116151
Effectiveness of a Cream for Treatment of Dermatitis in Patients Whith Breast Cancer
A study testing Cosmetic cream (Alantel (R): aloe vera, chamomile and thime) and Usual treatment in people with DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
Trial summary
It is intended to evaluate the effect of a marketed cream (Alantel®) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in cancer patients. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER
- What is being tested?
- Cosmetic cream (Alantel (R): aloe vera, chamomile and thime) and Usual treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteSpain
- Study dates
- 19 Jul 2022to 30 Jul 2023
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients 14 years of age or older
- Diagnosed with cancer and who are or have recently received radiotherapy treatment.
- We will include patients without dermatitis or with acute dermal posttradiotherapy lesions, in grades 1 and 2.
Who cannot join
- Patients with dermal lesions in grade greater than 2.
- Skin cancer invasion or distant tumor metastasis.
- Concurrent chemotherapy with RT, severe / extensive burns, moisture, erosion or suppuration in the skin, history of connective tissue disorders, severe mental disorder (dementia, drug addiction, etc.).
- History of hypersensitivity reaction to any of the ingredients of the studio cream.
- Participants involved in other clinical trials within that month.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectivenes and Safety of a Cream of Aloe Vera, Camomila and Tomillo (Alantel) for Profilaxis or Treatmment of Deratitis by Radiotheraphy in Patients With Breast Cancer
It is intended to evaluate the effect of a marketed cream (Alantel®) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in cancer patients. For this, an experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicentre, will be carried out in which doctors will recruit 78 patients aged 14 years or over in Primary Care consultations. more, diagnosed with cancer, and having received radiotherapeutic cancer treatment, being randomly assigned to the experimental group (cosmetic cream) or the control group (emollient and moisturizing cream). The main variable will be the incidence rate of mild post-translational dermatitis and its improvement or cure once it has been established.
- Being tested
- Cosmetic cream (Alantel (R): aloe vera, chamomile and thime), Usual treatment
- Keywords
- BREAST CANCER, DERMATITIS
- Medical subject headings
- Breast Neoplasms, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)Combination product
Application on the affected skin of the cream to be tested
Usual treatmentCombination product
Application on the affected skin of the emollient and moisturizing substance
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Local administration of the Alantel (R) cream on the affected skin Receives: Combination Product: Cosmetic cream (Alantel (R): aloe vera, chamomile and thime) |
| Control group | Placebo comparator | Local administration of the Placebo cream on the affected skin Receives: Combination Product: Usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of radiation-induced dermatitis
Measured: three weeks
Analog visual scale
Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..)
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start19 Jul 2022
- Primary completion30 May 2023
- Study completion30 Jul 2023
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 DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCERStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicenter study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Reina Sofia de Cordoba
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Luis A Perula, Hospital Universitario Reina Sofia de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116151
- Sponsor's protocol ID
- Alantel
- Acronym
- Alantel
- Status last verified
- Feb 2024
- First submitted
- 18 Sep 2019
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jimenez-Garcia C, Perula-de Torres LA, Villegas-Becerril E, Munoz-Gavilan JJ, Espinosa-Calvo M, Montes-Redondo G, Romero-Rodriguez E; Alantel Trial Collaborative Group. Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials). Trials. 2024 Jan 25;25(1):84. doi: 10.1186/s13063-024-07901-8.
PubMed 38273379
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivenes and Safety of a Cream of Aloe Vera, Camomila and Tomillo (Alantel) for Profilaxis or Treatmment of Deratitis by Radiotheraphy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT04116151
- Acronym / sponsor ID
- Alantel / Alantel
- Keywords
- BREAST CANCER, DERMATITIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Hospital Universitario Reina Sofia de CordobaOther government
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 4 Oct 2019 (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.
It is intended to evaluate the effect of a marketed cream (Alantel®) based on natural products at high concentrations for the preventive and curative treatment (early stages) of radiation-induced dermatitis in cancer patients. For this, an experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicentre, will be carried out in which doctors will recruit 78 patients aged 14 years or over in Primary Care consultations. more, diagnosed with cancer, and having received radiotherapeutic cancer treatment, being randomly assigned to the experimental group (cosmetic cream) or the control group (emollient and moisturizing cream). The main variable will be the incidence rate of mild post-translational dermatitis and its improvement or cure once it has been established.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Experimental, prospective, controlled clinical trial, with two parallel arms, double blind, multicenter study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Combination Product: Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)Local administration of the Alantel (R) cream on the affected skin |
| Control group | Placebo comparator | Combination Product: Usual treatmentLocal administration of the Placebo cream on the affected skin |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 14 years of age or older
- Diagnosed with cancer and who are or have recently received radiotherapy treatment.
- We will include patients without dermatitis or with acute dermal posttradiotherapy lesions, in grades 1 and 2.
Key exclusion criteria (5 listed)
- Patients with dermal lesions in grade greater than 2.
- Skin cancer invasion or distant tumor metastasis.
- Concurrent chemotherapy with RT, severe / extensive burns, moisture, erosion or suppuration in the skin, history of connective tissue disorders, severe mental disorder (dementia, drug addiction, etc.).
- History of hypersensitivity reaction to any of the ingredients of the studio cream.
- Participants involved in other clinical trials within that month.
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 |
|---|---|---|
| Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)Application on the affected skin of the cream to be tested | Combination product | Intervention group |
| Usual treatmentApplication on the affected skin of the emollient and moisturizing substance | Combination product | Control group |
Primary outcome
Incidence of radiation-induced dermatitis
Time frame: three weeks
Analog visual scale
Time frame: three weeks
Analog visual scale from 0 to 10 points to assess the symptomatology perceived by the patient (pain, stinging, ..)
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 5 Feb 2024.
- Derived from this study: PubMed 38273379Jimenez-Garcia C, Perula-de Torres LA, Villegas-Becerril E, Munoz-Gavilan JJ, Espinosa-Calvo M, Montes-Redondo G, Romero-Rodriguez E; Alantel Trial Collaborative Group. Efficacy of an aloe vera, chamomile, and thyme cosmetic cream for the prophylaxis and treatment of mild dermatitis induced by radiation therapy in breast cancer patients: a controlled clinical trial (Alantel Trials). Trials. 2024 Jan 25;25(1):84. doi: 10.1186/s13063-024-07901-8.
- 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 study testing Cosmetic cream (Alantel (R): aloe vera, chamomile and thime) and Usual treatment in people with DERMATITIS INDUCED BY RADIOTHERAPY IN PATIENTS WHITH BREAST CANCER, run by Hospital Universitario Reina Sofia de Cordoba at 1 site in Spain.
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 3 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 5 Feb 2024. 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 Spain. 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?
Incidence of radiation-induced dermatitis (time frame: three weeks). 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?
On the ClinicalTrials.gov record for NCT04116151, 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 5 Feb 2024.