Clinical trial NCT02261181: Preemptive Treatment With XONRID to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients
Official title: Preemptive Treatment With XONRID a Medical Device to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients Receiving Curative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: head neck cancer XONRID radiation induced dermatitis
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
First posted: 2014-10-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is a strong need to study products with a preemptive role in radiation dermatitis development, with a trial design taking in account patient subjective evaluation and compliance.

XONRID is a promising device for radiation high grade dermatitis prevention; it is a topical gel that prevents and treats skin symptoms such as erythema, itching, burning sensation and pruritus, induced by radiotherapy or other causes.

Detailed description: The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients in the Institution.

Patients will be planned to receive Intensity-Modulated Radiotherapy Techniques (IMRT or volumetric modulated radiotherapy, VMAT) with conventional fractionation at total dose of 50-66 GY in postoperative setting and 66-70 Gy in radical setting. Radiotherapy will be planned with simultaneous boost (SIB) approaches, using conventional fractionation (1.8-2.12 Gy/die). According to histology, stage and pathology reports, patients could receive concomitant platinum based chemotherapy.

The patients will be evaluated at baseline, at weekly intervals during RT and six months after treatment completion by 2 different treating physicians for each visit. The evaluation will consist of a physician-assessed toxicity assessment using the Radiation Therapy Oncology Group (RTOG), and patient-reported outcome measured using the Skindex-16 questionnaire.

In addition objective in vivo measurements of skin erythema and pigmentation based on reflectance spectrometry (RS) will be performed.

Measurements will be performed before RT, every 5 RT fractions (once a week) up to the end of RT and 6 months after RT completion (same timing as clinical evaluation). Instrumental RS measurement will be performed at five different fixed regions within the area treated with RT, in any cases only on flat skin regions of the neck in an area corresponding to the second node level and in absence of hair or nevus.

Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Performance status \< 2
* Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands
* Planned to receive at least 50 Gy on one side of the neck with at least the 2nd level of neck nodes irradiated
* Postoperative or curative radiation treatment
* Concurrent platinum based chemotherapy is accepted, but not mandatory
* Conventional fractionation (1.8-2.12 GY per fraction, one daily fraction, 5 fractions a week )

Exclusion Criteria:

* Pregnant or lactating women
* Planned to receive concurrent cetuximab
* Previous radiation therapy on the head and neck area
* Cutaneous and connettive 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

Primary outcomes:
measure: Worst skin toxicity
timeFrame: 14 months
Secondary outcomes:
measure: MeanPatient Reported Outcome (PRO)
timeFrame: 14 months
measure: Median time to G2 radiation dermatitis development
timeFrame: 14 months
measure: Compliance
timeFrame: 14 months
measure: Grade of late toxicity
timeFrame: 14 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Ester Orlandi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ingargiola R, De Santis MC, Iacovelli NA, Facchinetti N, Cavallo A, Ivaldi E, Dispinzieri M, Franceschini M, Giandini C, Romanello DA, Di Biaso S, Sabetti M, Locati L, Alfieri S, Bossi P, Guglielmo M, Macchi F, Lozza L, Valdagni R, Fallai C, Pignoli E, Orlandi E. A monocentric, open-label randomized standard-of-care controlled study of XONRID(R), a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients. Radiat Oncol. 2020 Aug 13;15(1):193. doi: 10.1186/s13014-020-01633-0.