Status:
COMPLETED
Efficacy and Safety of CareMin650 for Prevention of Oral Mucositis in HNC Patients Starting Radiotherapy
Lead Sponsor:
NeoMedLight
Collaborating Sponsors:
Monitoring Force Group
Conditions:
Head and Neck Cancer
Oral Mucositis (Ulcerative) Due to Radiation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Oral mucositis (OM) can affect up to 90% of head and neck cancer (HNC) patients treated with radiation therapy (RT). The Mucositis Study Group of the Multinational Association of Supportive Care in Ca...
Detailed Description
Oral mucositis (OM) can affect up to 90% of head and neck cancer (HNC) patients treated with radiation therapy (RT) and/or chemotherapy (CT). It can be as severe as WHO grade 3 / 4 in 35% to more than...
Eligibility Criteria
Inclusion
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2.
- Histologically proven squamous cell carcinoma of oropharynx, hypo pharynx or oral cavity, with or without prior surgical resection.
- Starting intensity modulated radiation therapy (IMRT) or VoluMetric Arc Therapy (VMAT) on at least 50% of the oral mucosa at a total dose of at least 50 Gy, alone or associated with chemotherapy or targeted therapies.
- Dental examination prior to radiotherapy and any required dental treatment have been performed.
Exclusion
- Any ongoing malignancy located in head or neck other than primary head and neck cancer (distant metastasis or extension).
- Any active cancer other than primary head and neck cancer.
- Only enteral/parenteral feeding or only liquid food intake are possible.
- Ongoing keratinocyte growth factors (palifermin) use.
- Known polyurethane allergy.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04699487
Start Date
May 10 2021
End Date
June 30 2022
Last Update
October 10 2022
Active Locations (1)
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1
UNIKLINIK RWTH AACHEN - Klinik für Radioonkologie und Strahlentherapie
Aachen, Germany, 52074