Efficacy and Safety of CareMin650 for Prevention of Oral Mucositis in HNC Patients Starting Radiotherapy

NCT04699487 | Completed DMC

• 1 other identifier: NML-20-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 Cancer and International Society of Oral Oncology (MASCC/ISOO) recommends the use of photobiomodulation (PBM) in the prevention of OM. PBM is the application of lasers or non-coherent light sources such as LEDs, to beneficially influence cellular metabolism. Even though PBM has proved its efficacy, this therapeutic option is currently limited by lack of standardization, accuracy and reproducibility. CareMin650 has been developed to overcome these issues, since it allows a reproducible delivery of light, independently of the operator. Additionally, it is easy to use and user-friendly. PrOMiSE is a prospective, interventional, one-group, open-label, multicentric, international study conducted in European sites, specialized in radio-oncology. Patients with head and neck cancer (HNC) starting RT and with no oral mucositis (OM) lesion at the time of inclusion, will be eligible. They will be treated by PBM using CareMin650 during the whole period of radiotherapy.

Conditions

Head and Neck Cancer; Oral Mucositis (Ulcerative) Due to Radiation; Radiation Therapy Complication

Keywords

Photobiomodulation; Head and Neck Cancer; Oral Mucositis; Radiation Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with at least one OM grade >2 at any time during radiotherapy.

  To investigate the efficacy of CareMin650 in the prevention of oral mucositis in patients with HNC starting radiotherapy.

  5-10 weeks

Secondary Outcomes (13)

• Frequency of AE classified using MedDRA dictionary

  5-10 weeks

• Grading of AE using CTCAE V5

  5-10 weeks

• Number of patient with a temporary or sustains discontinuation of PBM due to AE

  5-10 weeks

• Time to OM lesions occurrence

  5-10 weeks

• Grade (WHO and CTCAE version 3) of OM lesions

  5-10 weeks

Other Outcomes (1)

• For each neck dermatitis lesion: date of onset, location and CTCAE v5 grade

  5-10 weeks

Study Arms (1)

Patient receiving Photobiomodulation

EXPERIMENTAL

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

Oral pads will be applied on irradiated areas presenting a risk of radiotherapy-related OM. In addition, a derma pad will be applied on the anterior face of the neck to protect the oropharynx from OM. The dose to be delivered, at each session and each applied area, has been set at 3 J/cm². In case a lesion appears, the dose will be increased to 6J/cm² for curative treatment. Treatment with CareMin650 must start on the first day of radiotherapy and will be administered during the whole radiotherapy period, ideally 5 days/week, at least 3 days/week, ideally before the radiotherapy session.

Patient receiving Photobiomodulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NeoMedLight: lead
• Monitoring Force Group: collaborator

Study Sites (1)

UNIKLINIK RWTH AACHEN - Klinik für Radioonkologie und Strahlentherapie

Aachen, 52074, Germany

Location

Related Publications (4)

• Trotti A, Bellm LA, Epstein JB, Frame D, Fuchs HJ, Gwede CK, Komaroff E, Nalysnyk L, Zilberberg MD. Mucositis incidence, severity and associated outcomes in patients with head and neck cancer receiving radiotherapy with or without chemotherapy: a systematic literature review. Radiother Oncol. 2003 Mar;66(3):253-62. doi: 10.1016/s0167-8140(02)00404-8.

  PMID: 12742264 BACKGROUND

• Elad S, Cheng KKF, Lalla RV, Yarom N, Hong C, Logan RM, Bowen J, Gibson R, Saunders DP, Zadik Y, Ariyawardana A, Correa ME, Ranna V, Bossi P; Mucositis Guidelines Leadership Group of the Multinational Association of Supportive Care in Cancer and International Society of Oral Oncology (MASCC/ISOO). MASCC/ISOO clinical practice guidelines for the management of mucositis secondary to cancer therapy. Cancer. 2020 Oct 1;126(19):4423-4431. doi: 10.1002/cncr.33100. Epub 2020 Jul 28.

  PMID: 32786044 BACKGROUND

• Antunes HS, Herchenhorn D, Small IA, Araujo CMM, Viegas CMP, de Assis Ramos G, Dias FL, Ferreira CG. Long-term survival of a randomized phase III trial of head and neck cancer patients receiving concurrent chemoradiation therapy with or without low-level laser therapy (LLLT) to prevent oral mucositis. Oral Oncol. 2017 Aug;71:11-15. doi: 10.1016/j.oraloncology.2017.05.018. Epub 2017 Jun 3.

  PMID: 28688677 BACKGROUND

• Pulito C, Cristaudo A, Porta C, Zapperi S, Blandino G, Morrone A, Strano S. Oral mucositis: the hidden side of cancer therapy. J Exp Clin Cancer Res. 2020 Oct 7;39(1):210. doi: 10.1186/s13046-020-01715-7.

  PMID: 33028357 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Stomatitis; Ulcer

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Michael J Elbe, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 7, 2021
• Study Start: May 10, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)