Dermatitis, Radiation-Induced, Radiodermatitis
Conditions
Keywords
Radiodermatitis, DermoRelizema cream, DRESDA, Sodium Hyaluronate Butyrate Formiate, RELIFE
Brief summary
This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women with breast cancer. Assessments and evaluations will be performed by a physician in a blind fashion. The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity, using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC), at the conclusion of the treatment period
Detailed description
This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women with breast cancer. Assessments and evaluations will be performed by a physician in a blind fashion. The aim of this clinical study is to collect controlled evidences of the effectiveness and tolerability of DermoRelizemaTM cream in the management of RISRs in patients with breast cancer who will start the treatment with the product about one week before the start of RT. The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity, using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC), at the conclusion of the treatment period
Interventions
DEVICEDermoRelizema cream
Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
DEVICEDexeryl
FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Sponsors
Relife Italia S.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessments and evaluations will be performed by a physician in a blind fashion.
Intervention model description
This is a post marketing, interventional, randomized, single-center, prospective, controlled study. Assessments and evaluations will be performed by a physician in a blind fashion.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women who give their written consent for participation in the study and willing to comply with all its procedures. * Age ≥18 years. * Women with breast cancer at any stage who have undergone quadrantectomy, for whom hypofractionated adjuvant RT of the thoracic region is indicated. * RTOG/ EORTC radiodermatitis grade equal to 0 (zero) and good cutaneous trophism, in the region to be treated, according to investigator's judgement. * Patients who are supposed to be cooperative with regard to compliance with study-related constraints.
Exclusion criteria
* Pregnant or lactating women (as not eligible to RT), and fertile women not following, at the investigators' judgement, an adequate contraceptive method. * Subjects incapable of giving consent. * Concomitant inflammatory skin diseases in acute phase such as: atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea. * Collagen vascular disease, vasculitis, scleroderma, dermatomyositis, or systemic lupus erythematosus. * Unhealed surgical sites, breast infections. * Bilateral breast cancer or multiple neoplasia needing other independent RT treatments. * Prior breast reconstructions, implants, and/or expanders. * Known radio-sensitivity syndromes (e.g. ataxia-telangiectasia). * Known history of intolerance or hypersensitivity to any ingredient of the study products. * Previous RT in the same or different location. * Topical pharmacological and medical device treatments on the skin region affected by the RT, in the last 2 weeks. * Systemic or topical (including inhaled or intranasal) treatments containing corticosteroids of any class in the 2 days preceding the enrolment. * Photo-therapy (PUVA, UVB) in the 2 weeks preceding the enrolment and/or planned to be administered during the course of the study. * Participation in another clinical trial at the time of the randomization or within 28 days before randomization. * Patient's difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progression of Radio Therapy Induced Skin Reaction | two weeks after the last RT sessiont,day 35-42 | Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | up to 1 year | Evaluation of dermatitis symptoms management |
| Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) | Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC (system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer(grade 0-1: treatment is succesfull, grade 1 or magior: treatment insuccesful) ), at visits 2, 3 and 4 |
| Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) | Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale. The severity of radiation dermatitis was measured using this scoring system, range 0.0 to 4.0 at increments of 0.5. The RDS score incorporates changes in redness, pigment, texture and integrity of the skin ( grade 0: best result, grade 4§: worst result) |
| Progression of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56 | 1\. Evaluation of the effects of DermoRelizemaTM cream, in the management of the progression of RT-induced skin reactions and toxicity, using the (RTOG/ EORTC) at the conclusion of the radiotherapy treatment (V2) and at study end (V4) |
| Patient Opinion on Cream With a Likert Scale | up to 1 year | Overall patient's opinion on the products' pleasantness |
| Adherence to Treatment of Patients | up to 1 year | Patient's adherence to treatment on a diary's scale ( 10 points, in whitc: 1 is the best, 100 is the worst) |
| Occurrence of Adverse Events | up to 1 year | Occurrence of Adverse Events |
| Number of Participants With Progression of Radio Therapy Induced Skin Reaction | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) | Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters, |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DermoRelizema Cream The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
DermoRelizema cream: Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment | 31 |
| Dexeryl The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
Dexeryl: FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total). | 30 |
| Total | 61 |
Baseline characteristics
| Characteristic | Total | Dexeryl | DermoRelizema Cream |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants | 30 Participants | 31 Participants |
| Age, Continuous | 59.34 years STANDARD_DEVIATION 10.15 | 59.56 years STANDARD_DEVIATION 9.43 | 59.11 years STANDARD_DEVIATION 10.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants | 30 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Italy | 61 participants | 30 participants | 31 participants |
| Sex: Female, Male Female | 61 Participants | 30 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Number of Participants With Progression of Radio Therapy Induced Skin Reaction
Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity
Time frame: two weeks after the last RT sessiont,day 35-42
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermoRelizema Cream | Number of Participants With Progression of Radio Therapy Induced Skin Reaction | 35 Participants |
| Dexeryl | Number of Participants With Progression of Radio Therapy Induced Skin Reaction | 33 Participants |
Secondary
Adherence to Treatment of Patients
Patient's adherence to treatment on a diary's scale ( 10 points, in whitc: 1 is the best, 100 is the worst)
Time frame: up to 1 year
Population: Patient's adherence to treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DermoRelizema Cream | Adherence to Treatment of Patients | 96.50 units on a scale | Standard Deviation 7.98 |
| Dexeryl | Adherence to Treatment of Patients | 97.50 units on a scale | Standard Deviation 8.82 |
Secondary
Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)
Evaluation of dermatitis symptoms management
Time frame: up to 1 year
Population: Number of patients that are better on the radiation symptoms reported by the patient in a diary
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DermoRelizema Cream | Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | pain | 15.56 units on a scale | Standard Deviation 15.58 |
| DermoRelizema Cream | Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | burning | 15.53 units on a scale | Standard Deviation 11.97 |
| DermoRelizema Cream | Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | itch | 14.42 units on a scale | Standard Deviation 10.29 |
| DermoRelizema Cream | Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | tenderness | 8 units on a scale | Standard Deviation 9.28 |
| Dexeryl | Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | tenderness | 12.96 units on a scale | Standard Deviation 9.58 |
| Dexeryl | Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | pain | 17.90 units on a scale | Standard Deviation 14.05 |
| Dexeryl | Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | itch | 15.79 units on a scale | Standard Deviation 10.81 |
| Dexeryl | Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | burning | 12.65 units on a scale | Standard Deviation 10.21 |
Secondary
Number of Participants With Progression of Radio Therapy Induced Skin Reaction
Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,
Time frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
Population: instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermoRelizema Cream | Number of Participants With Progression of Radio Therapy Induced Skin Reaction | 30 Participants |
| Dexeryl | Number of Participants With Progression of Radio Therapy Induced Skin Reaction | 28 Participants |
Secondary
Occurrence of Adverse Events
Occurrence of Adverse Events
Time frame: up to 1 year
Population: Adverse Events
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermoRelizema Cream | Occurrence of Adverse Events | 0 Participants |
| Dexeryl | Occurrence of Adverse Events | 0 Participants |
Secondary
Patient Opinion on Cream With a Likert Scale
Overall patient's opinion on the products' pleasantness
Time frame: up to 1 year
Population: patient's opinion on the products' pleasantness
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DermoRelizema Cream | Patient Opinion on Cream With a Likert Scale | smell pleasant/very pleasant | 18 Participants |
| DermoRelizema Cream | Patient Opinion on Cream With a Likert Scale | texture pleasant/very pleasant | 30 Participants |
| DermoRelizema Cream | Patient Opinion on Cream With a Likert Scale | spreadability pleasant/very pleasant | 30 Participants |
| DermoRelizema Cream | Patient Opinion on Cream With a Likert Scale | satisfaction pleasant/very pleasant | 29 Participants |
| Dexeryl | Patient Opinion on Cream With a Likert Scale | satisfaction pleasant/very pleasant | 27 Participants |
| Dexeryl | Patient Opinion on Cream With a Likert Scale | smell pleasant/very pleasant | 15 Participants |
| Dexeryl | Patient Opinion on Cream With a Likert Scale | spreadability pleasant/very pleasant | 28 Participants |
| Dexeryl | Patient Opinion on Cream With a Likert Scale | texture pleasant/very pleasant | 27 Participants |
Secondary
Progression of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
1\. Evaluation of the effects of DermoRelizemaTM cream, in the management of the progression of RT-induced skin reactions and toxicity, using the (RTOG/ EORTC) at the conclusion of the radiotherapy treatment (V2) and at study end (V4)
Time frame: at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DermoRelizema Cream | Progression of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | 27 Participants |
| Dexeryl | Progression of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | 26 Participants |
Secondary
Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale
Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale. The severity of radiation dermatitis was measured using this scoring system, range 0.0 to 4.0 at increments of 0.5. The RDS score incorporates changes in redness, pigment, texture and integrity of the skin ( grade 0: best result, grade 4§: worst result)
Time frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
Population: Evaluation of the severity of radiation dermatitis by the investigator
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DermoRelizema Cream | Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale | V1 skin healthy | 30 Participants |
| DermoRelizema Cream | Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale | V4 grade 0 | 29 Participants |
| Dexeryl | Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale | V1 skin healthy | 28 Participants |
| Dexeryl | Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale | V4 grade 0 | 25 Participants |
Secondary
Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)
Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC (system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer(grade 0-1: treatment is succesfull, grade 1 or magior: treatment insuccesful) ), at visits 2, 3 and 4
Time frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
Population: Evaluation of the severity of radiation dermatitis by the investigator
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DermoRelizema Cream | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V2 erythema grade 1 | 18 Participants |
| DermoRelizema Cream | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V3 erythema grade 1 | 13 Participants |
| DermoRelizema Cream | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V2 erythema grade 3 | 0 Participants |
| DermoRelizema Cream | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V3 erythema grade 3 | 1 Participants |
| DermoRelizema Cream | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V2 erythema grade 2 | 4 Participants |
| DermoRelizema Cream | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V4 no erythema | 29 Participants |
| DermoRelizema Cream | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V3 no erythema | 16 Participants |
| DermoRelizema Cream | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V4 erythema grade1 | 1 Participants |
| DermoRelizema Cream | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V2 no erythema | 9 Participants |
| Dexeryl | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V4 erythema grade1 | 3 Participants |
| Dexeryl | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V2 no erythema | 2 Participants |
| Dexeryl | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V2 erythema grade 1 | 24 Participants |
| Dexeryl | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V2 erythema grade 2 | 1 Participants |
| Dexeryl | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V2 erythema grade 3 | 1 Participants |
| Dexeryl | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V3 no erythema | 9 Participants |
| Dexeryl | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V3 erythema grade 1 | 18 Participants |
| Dexeryl | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V3 erythema grade 3 | 1 Participants |
| Dexeryl | Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC) | V4 no erythema | 25 Participants |