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Preemptive Treatment With XONRID to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02261181
Recruitment Status : Unknown
Verified January 2015 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : October 10, 2014
Last Update Posted : January 22, 2015
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Device: XONRID Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preemptive Treatment With XONRID a Medical Device to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients Receiving Curative Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: XONRID

Patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients.

Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines. The use of other topical medications for the treatment of dermatitis will be not permitted during the study.

Device: XONRID
The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines.




Primary Outcome Measures :
  1. Worst skin toxicity [ Time Frame: 14 months ]
    Worst skin toxicity during treatment and until 2 weeks after according to CTCAE , as assessed independently by 2 physicians


Secondary Outcome Measures :
  1. MeanPatient Reported Outcome (PRO) [ Time Frame: 14 months ]
    Mean and worst score (measured on a numeric 0-6 scale, where 0= absence of symptom and 6= worst intensity of symptom) of Patient Reported Outcome (PRO) with Skindex 16 questionnaire performed weekly until reaching a total dose of 50 Gy on neck

  2. Median time to G2 radiation dermatitis development [ Time Frame: 14 months ]
    Median time to G2 radiation dermatitis development according to CTCAE

  3. Compliance [ Time Frame: 14 months ]
    Compliance to experimental treatment assumption considering a complete cpmpliance from 0 to 2 applications skipped, a partial compiance from 3 to 10 applications skipped and an absent compliance from 11 to 14 applications skipped.

  4. Grade of late toxicity [ Time Frame: 14 months ]
    Grade of late toxicity (skin fibrosis according to CTCAE) at 6 month follow up visit after treatment ending



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261181


Contacts
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Contact: Ester Orlandi, MD +39 022390 ext 3265 ester.orlandi@istitutotumori.mi.it
Contact: Paolo Bossi, MD +39 022390 ext 2765 paolo.bossi@istitutotumori.mi.it

Locations
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Italy
Fondazione IRCCS Istituto Nazionale Tumori Recruiting
Milan, Italy, 20133
Contact: Ester Orlandi, MD    +39 022390 ext 3265    ester.orlandi@istitutotumori.mi.it   
Contact: Paolo Bossi, MD    +39 022390 ext 2765    paolo.bossi@istitutotumori.mi.it   
Principal Investigator: Ester Orlandi, MD         
Sub-Investigator: Paolo Bossi, MD         
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
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Principal Investigator: Ester Orlandi, MD Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT02261181    
Other Study ID Numbers: INT 52/14
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: January 22, 2015
Last Verified: January 2015
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
head neck cancer XONRID radiation induced dermatitis
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Skin Diseases
Radiation Injuries
Wounds and Injuries