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

• Sponsor: Helsinn Healthcare SA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03255980
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 31.2
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Radiodermatitis; Quality of Life	Device: Xonrid® gel; Other: Standard of Care	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: MONOCENTER, OPEN LABEL CLINICAL INVESTIGATIONMONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
• Masking: None (Open Label)
• Primary Purpose: Other
• 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.
• Actual Study Start Date: Jun 15, 2017
• Actual Primary Completion Date: Feb 20, 2019
• Actual Study Completion Date: Jan 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Xonrid® Xonrid® is a medical device for radiation dermatitis	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
Active Comparator: Standard of Care Standard of care suggested by MASCC guidelines	Device: Xonrid® gel; Water based gel for the management of toxicity skin symptoms induced by Radiotherapy

Outcome Measures

Primary Outcome Measures

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

1. Median Time to G2 Radiodermatitis Development [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 [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 [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. [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 [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 [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 [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 [6 weeks over 7 weeks]

   Global patient's satisfaction recorded by the Linkert Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione IRCCS Istituto Nazionale dei Tumori	Milan		Italy	20133

Sponsors and Collaborators

• Helsinn Healthcare SA

Investigators

• Principal Investigator: Orlandi Ester, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Documents (Full-Text)

• Study Protocol - Feb 6, 2017
• Statistical Analysis Plan - Dec 18, 2018

More Information

Publications

None provided.

• Responsible Party: Helsinn Healthcare SA
• ClinicalTrials.gov Identifier: NCT03255980
• Other Study ID Numbers: HD01-16-30
• First Posted: Aug 21, 2017
• Last Update Posted: Dec 16, 2020
• Last Verified: Jan 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Dermatitis; Radiodermatitis

Study Results

Participant Flow

Recruitment Details	FPI: June 2017 LPO: July 2018

Arm/Group Title	Breast Cancer Group: Xonrid+SOC	Breast Cancer Group: SOC	Head and Neck Cancer Group: Xonrid + SOC	Head and Neck Cancer Group: SOC
Arm/Group Description	Patients treated with the device under evaluation and according to MASCC guidelines	Patients treated with Standard of Care according to MASCC guidelines	H&N Patients treated with the device under evaluation and according to MASCC guidelines	H&N Cancer Patients treated with Standard of Care according to MASCC guidelines
Period Title: Overall Study
STARTED	20	20	20	20
COMPLETED	17	12	14	8
NOT COMPLETED	3	8	6	12

Baseline Characteristics

Arm/Group Title	Breast Cancer Group: Xonrid+SOC	Breast Cancer Group: SOC	Head and Neck Cancer Group: Xonrid + SOC	Head and Neck Cancer Group: SOC	Total
Arm/Group Description	Patients treated with the device under evaluation and according to MASCC guidelines	Patients treated with Standard of Care according to MASCC guidelines	H&N Patients treated with the device under evaluation and according to MASCC guidelines	H&N Cancer Patients treated with Standard of Care according to MASCC guidelines	Total of all reporting groups
Overall Participants	20	20	20	20	80
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.56 (4.80)	49.01 (4.54)	55.73 (12.46)	59.49 (12.34)	53.45 (8.52)
Sex: Female, Male (Count of Participants)
Female	20 100%	20 100%	4 20%	4 20%	48 60%
Male	0 0%	0 0%	16 80%	16 80%	32 40%
Race/Ethnicity, Customized (Caucasian) [Number]
Number [Caucasian]	20	20	20	20	80
Region of Enrollment (participants) [Number]
Italy	20 100%	20 100%	20 100%	20 100%	80 100%

Outcome Measures

1. Primary Outcome

Title	Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
Description	The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis < G2) at week 5
Time Frame	5 weeks over 7 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Breast Cancer Group: Xonrid+SOC	Breast Cancer Group: SOC	Head and Neck Cancer Group: Xonrid + SOC	Head and Neck Cancer Group: SOC
Arm/Group Description	Patients treated with the device under evaluation and according to MASCC guidelines	Patients with Breast Cancer treated with Standard of Care according to MASCC guidelines	H&N Patients treated with the device under evaluation and according to MASCC guidelines	H&N Cancer Patients treated with Standard of Care according to MASCC guidelines
Measure Participants	18	18	20	16
Number [participants]	10 50%	5 25%	13 65%	11 55%

2. Secondary Outcome

Title	Median Time to G2 Radiodermatitis Development
Description	Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation
Time Frame	5 weeks over 7 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	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
Description	Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans
Time Frame	5 weeks over 7 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation
Description	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.
Time Frame	6 weeks over 7 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.
Description	The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.
Time Frame	Follow-up: 2 weeks after the completion of radiation treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation
Description	Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema
Time Frame	weekly during teratment (7 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

7. Secondary Outcome

Title	The Mean and Worst Score of Skindex-16 Questionnaire
Description	Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16
Time Frame	5 weeks over 7 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	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
Description	Compliance is based on the total amount ( weight) of Xonrid used over the treatment period
Time Frame	5 weeks over 7 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale
Description	Global patient's satisfaction recorded by the Linkert Scale
Time Frame	6 weeks over 7 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	13 months
Arm/Group Title	Breast Cancer: Xonrid® +SOC		Breast Cancer: Standard Of Care		Head and Neck Cancer: Xonrid + SOC		Head and Neck Cancer: Standard of Care
Arm/Group Description	Xonrid® is a medical device for radiation dermatitis Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines		Standard of care suggested by MASCC guidelines		Xonrid® is a medical device for radiation dermatitis Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines		Standard of care suggested by MASCC guidelines
All Cause Mortality
	Breast Cancer: Xonrid® +SOC		Breast Cancer: Standard Of Care		Head and Neck Cancer: Xonrid + SOC		Head and Neck Cancer: Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Breast Cancer: Xonrid® +SOC		Breast Cancer: Standard Of Care		Head and Neck Cancer: Xonrid + SOC		Head and Neck Cancer: Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Skin and subcutaneous tissue disorders
pruritus	1/20 (5%)	1	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0
Other (Not Including Serious) Adverse Events
	Breast Cancer: Xonrid® +SOC		Breast Cancer: Standard Of Care		Head and Neck Cancer: Xonrid + SOC		Head and Neck Cancer: Standard of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/20 (5%)		0/20 (0%)		0/20 (0%)		0/20 (0%)
Infections and infestations
Ear Infection	1/20 (5%)	1	0/20 (0%)	0	0/20 (0%)	0	0/20 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.