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

Quality of Life Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03255980
• Other study ID #: HD01-16-30
• Status: Completed
• Phase: N/A
• Start date: June 15, 2017
• Est. completion date: January 22, 2020

Study information

• Verified date: January 2020
• Source: Helsinn Healthcare SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 22, 2020
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Quality of Life
• Radiodermatitis

Intervention

Device:
• Xonrid® gel
Water based gel for the management of toxicity skin symptoms induced by Radiotherapy

Other:
• Standard of Care
Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Helsinn Healthcare SA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5	The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis < G2) at week 5	5 weeks over 7 weeks
Secondary	Median Time to G2 Radiodermatitis Development	Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation	5 weeks over 7 weeks
Secondary	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	Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans	5 weeks over 7 weeks
Secondary	The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation	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.	6 weeks over 7 weeks
Secondary	The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.	The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.	Follow-up: 2 weeks after the completion of radiation treatment
Secondary	The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation	Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema	weekly during teratment (7 weeks)
Secondary	The Mean and Worst Score of Skindex-16 Questionnaire	Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16	5 weeks over 7 weeks
Secondary	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	Compliance is based on the total amount ( weight) of Xonrid used over the treatment period	5 weeks over 7 weeks
Secondary	The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale	Global patient's satisfaction recorded by the Linkert Scale	6 weeks over 7 weeks