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Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®

NCT ID: NCT03255980

Last Updated: 2020-12-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2020-01-22

Brief Summary

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To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.

Detailed Description

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The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients can be a valid support, when compared to the Standard of Care as defined by MASCC (Multinational Association for Supportive Care in Cancer) guidelines.

Conditions

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Radiodermatitis Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Xonrid®

Xonrid® is a medical device for radiation dermatitis

Group Type EXPERIMENTAL

Xonrid® gel

Intervention Type DEVICE

Water based gel for the management of toxicity skin symptoms induced by Radiotherapy

Standard of Care

Intervention Type OTHER

Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines

Standard of Care

Standard of care suggested by MASCC guidelines

Group Type ACTIVE_COMPARATOR

Xonrid® gel

Intervention Type DEVICE

Water based gel for the management of toxicity skin symptoms induced by Radiotherapy

Interventions

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Xonrid® gel

Water based gel for the management of toxicity skin symptoms induced by Radiotherapy

Intervention Type DEVICE

Standard of Care

Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Male and female which are 18 years of age or older
2. Performance status \< 2
3. Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
4. Postoperative or curative radiation treatment
5. Concurrent chemotherapy is accepted, in head \& neck cancer patients
6. Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.

Exclusion Criteria

1. Pregnant or lactating women
2. Planned to receive concurrent cetuximab
3. Previous radiation therapy on the head and neck area or breast and thorax areas
4. Cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma)
5. Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure
6. Use of a tissue-equivalent bolus
7. Use of over-the-counter topical medications containing steroids
8. Presence of rashes or unhealed wounds in the radiation field
9. Recent sun exposure
10. Mental conditions that could adversely affect patients' adherence to the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinn Healthcare SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Orlandi Ester, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Locations

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Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, , Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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HD01-16-30

Identifier Type: -

Identifier Source: org_study_id