Dermatitis, Adverse Drug ReactionPhase 1/2B-DUOLNCT02036957
MARY DUOL REPAIR BALM IN THE PREVENTION OR REDUCING ANTINEOPLASIC AGENTS' SKIN TOXICITY
A Phase 1/2 study testing BALM ARM in people with Dermatitis, Adverse Drug Reaction, run by Basque Health Service at 1 site in Spain.
Trial summary
Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash, peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers , photosensitivity reactions, swelling of the face and… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Dermatitis, Adverse Drug Reaction
- What is being tested?
- BALM ARM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2014to Jun 2017
- Phase
- Phase 1/2
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Over 18 years.
- Sign the informed consent
Who cannot join
- Patients with neoadjuvant treatment.
- Patients with dermatologic diseases.
- Patients treated with corticosteroids.
Trial locations and contacts
1 site in 1 country.
Patricia Seaone, MD contact
Spain1 site, 1 recruiting
- Recruiting
University hospital of Araba
Vitoria-Gasteiz, Álava, 01009
Arantza Saez de Lafuente
Carlos Peña
About this study
Official title: EFFECTIVENESS OF MARY D'UOL REPAIR BALM FOR PREVENTING AND / OR REDUCING TOXICITY SKIN IN PATIENTS WITH CANCER AND TREATMENT WITH ANY Antineoplastic Agent. RANDOM CLINICAL TRIAL.
Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash, peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers , photosensitivity reactions, swelling of the face and purple) . The impact in patients' quality of life is great, so We had decided to conduct a randomized clinical trial to evaluate the effectiveness Mary D' uol balm preventing dermatologic toxicity in patient treated with capecitabine .
Design: Randomized clinical trial phase II, in parallel and double-blind groups
Read more
Target population : Patients with colon cancer stage II or III ( Dukes' C ) , who will initiate treatment with capecitabine monotherapy.
Inclusion criteria: Over 18 years, II or III colon (Dukes' C) colon cancer, primary diagnosis, capecitabine monotherapy, sign the informed consent.
Primary endpoint: Dermatologic toxicity (yes / no) Statistical analysis: The primary endpoint (percentage of patients that develop dermalogic toxocity in both groups) will be analyzed by a logistics regression model
Read the detailed description
Intervention: Preventive treatment of dermatologic toxicities begin on the day of initiation of treatment with Xeloda, capecitabine + oxaliplatin, Adriamycin Liposomial or cytarabine
The product will be applied throughout the body in abundant quantities so that the skin is perfectly hydrated. It is applied twice daily (after showering and evening), gently massaging the area until completely absorbed.
The product will be provided at the unit of oncology pharmacy, when the patient is randomized. 3 packs per cycle will be provided. If not enough (because the patient has greater surface area) will be supplied more. Each time you start a new cycle 3 new packages will be delivered.
The patient will not apply any other cosmetic product in the treated areas.
In addition all patients regardless of the group will receive recommendations for reducing the appearance of skin problems caused by these type of drugs.
The study will have a total duration of 24 weeks (8 cycles of chemotherapy), except in cases of patients requiring a cycle delay for filing toxicity. In these patients the total duration of the study must be sufficient to end the eighth cycle.
If the side effects are so severe that greatly affect the quality of life of the patient and the doctor thinks fit, may prescribe drug treatment.
- Conditions
- Dermatitis, Adverse Drug Reaction
- Being tested
- BALM ARM, PLACEBO ARM
- Keywords
- capecitabine, dermatologic toxicity
- Medical subject headings
- Drug Eruptions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BALM ARMProcedure or surgery
The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.
PLACEBO ARMProcedure or surgery
The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.
| Study group | Role | What they receive |
|---|---|---|
| BALM ARM | Experimental | The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. Will be applied twice a day (after showering and at night), massaging the area until completely absorption. Receives: Procedure: BALM ARM |
| PLACEBO ARM | Placebo comparator | It be applicated in like manner that balm arm Receives: Procedure: PLACEBO ARM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients who develop dermatologic toxicity.
Compare the percentage of patients who develop dermatologic toxicity in any grade (1-5) between intervention and control group at three months of starting treatment, through CTCAE scale (National Cancer Institute Common Toxicity Criteria).
Measured: 3 moths
Secondary outcomes (3)
Need of pharmacological treatment to mitigate toxicity
Compare the percentage of patients in both groups who required pharmacological treatment to mitigate the dermatologic toxicity produced by chemotherapy
Measured: 3 months
Quality of life
Compare the quality of life in both groups at three months, through the Skindex 29 scale to evaluate the quality of life due to skin disease.
Measured: 3 months
Percentaje of patients who have reduces skin toxicity
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, Adverse Drug ReactionStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Patricia Seoane, Basque Health Service
- Investigators
- Arantza Sáez de la Fuente, Msc, Study chair, Basque Health Service (Research Unit)Patricia Seaone, MD, Principal investigator, Basque Health Service (Research Unit)Raquel Cobos, Msc, Study chair, Basque Health Service (Research Unit)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036957
- Sponsor's protocol ID
- MD-01
- Acronym
- B-DUOL
- Status last verified
- Aug 2016
- First submitted
- 14 Jan 2014
- Last updated
- 2 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF MARY D'UOL REPAIR BALM FOR PREVENTING AND / OR REDUCING TOXICITY SKIN IN PATIENTS WITH CANCER AND TREATMENT WITH ANY Antineoplastic Agent. RANDOM CLINICAL TRIAL.
- ClinicalTrials.gov ID
- NCT02036957
- Acronym / sponsor ID
- B-DUOL / MD-01
- Conditions
- Dermatitis, Adverse Drug Reaction
- Keywords
- capecitabine, dermatologic toxicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- Feb 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 15 Jan 2014 (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.
Capecitabine is a drug that produces dermatologic toxicity frequently (palmoplantar erythrodysesthesia, rash , alopecia , erythema , dryness, pruritus, hyperpigmentation , rash, peeling , dermatitis , abnormal pigmentation, and less often blistering, skin ulcers , photosensitivity reactions, swelling of the face and purple) . The impact in patients' quality of life is great, so We had decided to conduct a randomized clinical trial to evaluate the effectiveness Mary D' uol balm preventing dermatologic toxicity in patient treated with capecitabine .
Design: Randomized clinical trial phase II, in parallel and double-blind groups
Target population : Patients with colon cancer stage II or III ( Dukes' C ) , who will initiate treatment with capecitabine monotherapy.
Inclusion criteria: Over 18 years, II or III colon (Dukes' C) colon cancer, primary diagnosis, capecitabine monotherapy, sign the informed consent.
Primary endpoint: Dermatologic toxicity (yes / no) Statistical analysis: The primary endpoint (percentage of patients that develop dermalogic toxocity in both groups) will be analyzed by a logistics regression model
Detailed description
Intervention: Preventive treatment of dermatologic toxicities begin on the day of initiation of treatment with Xeloda, capecitabine + oxaliplatin, Adriamycin Liposomial or cytarabine
The product will be applied throughout the body in abundant quantities so that the skin is perfectly hydrated. It is applied twice daily (after showering and evening), gently massaging the area until completely absorbed.
The product will be provided at the unit of oncology pharmacy, when the patient is randomized. 3 packs per cycle will be provided. If not enough (because the patient has greater surface area) will be supplied more. Each time you start a new cycle 3 new packages will be delivered.
The patient will not apply any other cosmetic product in the treated areas.
In addition all patients regardless of the group will receive recommendations for reducing the appearance of skin problems caused by these type of drugs.
The study will have a total duration of 24 weeks (8 cycles of chemotherapy), except in cases of patients requiring a cycle delay for filing toxicity. In these patients the total duration of the study must be sufficient to end the eighth cycle.
If the side effects are so severe that greatly affect the quality of life of the patient and the doctor thinks fit, may prescribe drug treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BALM ARM | Experimental | Procedure: BALM ARMThe product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. Will be applied twice a day (after showering and at night), massaging the area until completely absorption. |
| PLACEBO ARM | Placebo comparator | Procedure: PLACEBO ARMIt be applicated in like manner that balm arm |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years.
- Sign the informed consent
Key exclusion criteria (3 listed)
- Patients with neoadjuvant treatment.
- Patients with dermatologic diseases.
- Patients treated with corticosteroids.
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 |
|---|---|---|
| BALM ARMThe product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms. | Procedure or surgery | BALM ARM |
| PLACEBO ARMThe product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms. | Procedure or surgery | PLACEBO ARM |
Primary outcome
Percentage of patients who develop dermatologic toxicity.
Time frame: 3 moths
Compare the percentage of patients who develop dermatologic toxicity in any grade (1-5) between intervention and control group at three months of starting treatment, through CTCAE scale (National Cancer Institute Common Toxicity Criteria).
3 secondary outcomes
Need of pharmacological treatment to mitigate toxicity
Time frame: 3 months
Quality of life
Time frame: 3 months
Percentaje of patients who have reduces skin toxicity
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
Related trials for Dermatitis, Adverse Drug Reaction
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
Not yet recruitingEarly Phase 1
Traditional Chinese Medicine Treatment for Capecitabine-Related Hand-Foot Syndrome
Palmar and Plantar Erythema, Numbness of the Four Limbs
Not yet recruitingPhase 1
Subconjunctival Humira for Boston Keratoprosthesis
Penetrating Keratoplasty, Multiple Graft Failure
Not yet recruitingPhase 2
Isotretinoin vs. Doxycycline for Acneiform Rash in Patients Receiving Drugs That Target the MAPK Pathway
Acneiform Drug Eruption, Acneiform Eruptions
Not yet recruitingPhase 2
Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome)
DRESS Syndrome
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.
Patricia Seaone, MD contact
Arantza Sáez de la Fuente, Msc study chair
Basque Health Service (Research Unit)
Patricia Seaone, MD principal investigator
Basque Health Service (Research Unit)
Raquel Cobos, Msc study chair
Basque Health Service (Research Unit)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BALM ARM in people with Dermatitis, Adverse Drug Reaction, run by Basque Health Service 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 2 inclusion and 3 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 2 Aug 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Patricia Seaone, MD (945007000), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients who develop dermatologic toxicity. (time frame: 3 moths). 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 2 Aug 2016.