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NCT Number: NCT03255980

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

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

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Key information

Conditions

Radiodermatitis Dermatitis Quality of Life Radiation Injuries Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, 20133, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female which are 18 years of age or older
  • Performance status < 2
  • 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
  • Postoperative or curative radiation treatment
  • Concurrent chemotherapy is accepted, in head & neck cancer patients
  • 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

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

Treatment and study plan

Xonrid® gel

Device

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

Standard of care

Other

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

Primary outcomes

  1. Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5

    Time frame: 5 weeks over 7 weeks

    The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis < G2) at week 5

Secondary outcomes

  1. Median Time to G2 Radiodermatitis Development

    Time frame: 5 weeks over 7 weeks

    Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation

  2. The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head & Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites

    Time frame: 5 weeks over 7 weeks

    Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans

  3. The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation

    Time frame: 6 weeks over 7 weeks

    Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation for both cancer sites, at week 7 for head & neck cancer and 2 weeks after the last radiation for both cancer sites.

  4. The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.

    Time frame: Follow-up: 2 weeks after the completion of radiation treatment

    The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.

  5. The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation

    Time frame: weekly during teratment (7 weeks)

    Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema

  6. The Mean and Worst Score of Skindex-16 Questionnaire

    Time frame: 5 weeks over 7 weeks

    Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16

  7. The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product

    Time frame: 5 weeks over 7 weeks

    Compliance is based on the total amount ( weight) of Xonrid used over the treatment period

  8. The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale

    Time frame: 6 weeks over 7 weeks

    Global patient's satisfaction recorded by the Linkert Scale

Sponsors and collaborators

Lead sponsor

Helsinn Healthcare SA

Industry

Registry information

Official study title

Monocenter, Open Label Clinical Investigation on the Treatment With Xonrid®, a Medical Device for the Prevention and Treatment of Radiotherapy-induced Dermatitis, in Breast and Head & Neck Cancer Patients Receiving Curative Treatment.

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 21, 2017
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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