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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DermoRelizema cream | Experimental | The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end |
|
| Dexeryl | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DermoRelizema cream | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | two weeks after the last RT sessiont,day 35-42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
female patient with breast cancer
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| Name | Affiliation | Role |
|---|---|---|
| Mariangela Francomano | University of Modena and Reggio Emilia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Modena University Hospital | Modena | 41134 | Italy |
confidential information as per internal procedure of the Sponsor
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | two weeks after the last RT sessiont,day 35-42 |
|
up to 1 year
the adverse events are not related to the treatment performed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Coordinator | Relife Srl | 05556809528 | lfabbri@relifecompany.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2023 | Jun 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 14, 2023 | Jun 6, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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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.
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Not provided
Assessments and evaluations will be performed by a physician in a blind fashion.
|
| Dexeryl | Device | 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). |
|
| at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56 |
| Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | Evaluation of dermatitis symptoms management | up to 1 year |
| 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 | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) |
| 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) | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) |
| Number of Participants With Progression of Radio Therapy Induced Skin Reaction | Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters, | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) |
| Patient Opinion on Cream With a Likert Scale | Overall patient's opinion on the products' pleasantness | up to 1 year |
| 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) | up to 1 year |
| Occurrence of Adverse Events | Occurrence of Adverse Events | up to 1 year |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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). |
|
|
| 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) | Posted | Count of Participants | Participants | at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56 |
|
|
|
| Secondary | Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results) | Evaluation of dermatitis symptoms management | Number of patients that are better on the radiation symptoms reported by the patient in a diary | Posted | Mean | Standard Deviation | units on a scale | up to 1 year |
|
|
|
| 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 | Evaluation of the severity of radiation dermatitis by the investigator | Posted | Count of Participants | Participants | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) |
|
|
|
| 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) | Evaluation of the severity of radiation dermatitis by the investigator | Posted | Count of Participants | Participants | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) |
|
|
|
| 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, | instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters | Posted | Count of Participants | Participants | all study visits, day 21-28, day 35-42 and at the study end (day 49-56) |
|
|
|
| Secondary | Patient Opinion on Cream With a Likert Scale | Overall patient's opinion on the products' pleasantness | patient's opinion on the products' pleasantness | Posted | Count of Participants | Participants | up to 1 year |
|
|
|
| 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) | Patient's adherence to treatment | Posted | Mean | Standard Deviation | units on a scale | up to 1 year |
|
|
|
| Secondary | Occurrence of Adverse Events | Occurrence of Adverse Events | Adverse Events | Posted | Count of Participants | Participants | up to 1 year |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | 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). | 0 | 35 | 0 | 35 | 0 | 35 |
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| D014947 |
| Wounds and Injuries |
| burning |
|
| tenderness |
|
| V2 erythema grade 2 |
|
| V2 erythema grade 3 |
|
| V3 no erythema |
|
| V3 erythema grade 1 |
|
| V3 erythema grade 3 |
|
| V4 no erythema |
|
| V4 erythema grade1 |
|
| spreadability pleasant/very pleasant |
|
| satisfaction pleasant/very pleasant |
|