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JOURNAL ONKOLOGIE – STUDIE
PrOMiSE

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

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NCT-Nummer:
NCT04699487

Studienbeginn:
Februar 2021

Letztes Update:
07.01.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Head and Neck Neoplasms, Mucositis, Stomatitis

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
NeoMedLight

Collaborator:
Monitoring Force Group

Studienleiter

Michael J Elbe, MD
Principal Investigator

Kontakt

Studienlocations
(1 von 1)

Studien-Informationen

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 50% of cases. The pathobiology of OM relates to injuries that occur in the

epithelial and connective tissues, as a response to a complex cascade of biological events,

involving all the tissues and cellular elements of the mucosa (Sonis et al., 2004). OM may

result in dysphagia, pain, risk of infection, weight loss, interruption or modification of

anticancer therapy, or hospitalization.

As OM is a major and frequent side effect of RT, the Mucositis Study Group of the

Multinational Association of Supportive Care in Cancer and International Society of Oral

Oncology (MASCC/ISOO) has published clinical practice guidelines for mucositis prevention

secondary to cancer therapy. In addition to meticulous oral hygiene, MASCC/ISOO also suggests

several therapeutic preventive strategies: growth factors, cytokines, anti-inflammatory

agents, natural agents, … In the 2020 guidelines, photobiomodulation (PBM) formerly known as

Low-Level Laser Therapy (LLLT), has obtain a full recommendation for the prevention of OM in

patients undergoing RT, with or without concomitant CT, for HNC.

PBM is the application of lasers or non-coherent light sources such as LEDs, to beneficially

influence cellular metabolism. In a Cochrane review that included 32 clinical trials, PBM was

the only treatment that demonstrated a reduction in the risk of severe mucositis. In 2011, a

meta-analysis included 11 placebo-controlled randomized trials in 415 patients treated with

CT or RT for head and neck cancer (HNC) or hematopoietic stem cell transplantation. According

to MASCC/ISOO recommendations, PBM is now recommended to prevent OM in HNC patients receiving

RT with or without chemotherapy . The 2014 recommendations have been endorsed by the AFSOS

(Association Française pour les Soins de Support en Oncologie) in France. Finally, the

National Institute for Health and Care Excellence (NICE) determined that PBM for OM shows no

major safety concerns and that evidence on efficacy is adequate in quality and quantity.

Taken together, these data show that PBM is an efficacious and safe option to prevent and/or

treat radiotherapy-related OM.

Even though PBM has proved its efficacy, delivery of PBM in OM is currently limited by lack

of standardization, accuracy and reproducibility. In particular, the distance between the

lighting source and the mucosa or skin is difficult to assess and control accurately.

Therefore, the amount of energy delivered may vary from one session to another, as well as

from one operator to another.

CareMin650 has been developed to overcome these issues. CareMin650 allows a reproducible

delivery of light, independently of the operator. As light is emitted by a flexible surface

in contact with the mucosa or the skin, the dose delivered will be controlled. Additionally,

it is meant to be easy to use and user-friendly. An interim analysis of SafePBM, a pilot

study performed in France provided preliminary data on safety and efficacy. Among 186

CareMin650 sessions performed to prevent (n=152) or treat (n=34) OM in patients with HNC, no

treatment-emergent adverse event was considered related to the device and no adverse event

led to CareMin650 discontinuation. Only one out of 7 (14%) HNC patients treated in the

preventative setting developed OM grade 3. However, this patient had started PBM 6 days after

the initiation of RT, instead of starting at day 1 of RT. These encouraging results suggest

that CareMin650 is both well tolerated and efficient to prevent severe OM in these high-risk

patients.

The aim of the present study is to show the efficacy and safety of the CareMin650 medical

device, in the prevention of severe OM in HNC patients receiving radiotherapy. The rate of

severe OM will be compared to severe OM rate reported in the literature.

This is a prospective, interventional, one-group, open-label, multicentric, international

study that will be conducted in Belgian and German sites, specialized in radio-oncology.

Photobiomodulation will be delivered to all included patients with the CareMin650

(NeoMedLight).

The studied Device CareMin 650 consists in a lightbox and a light applicator that delivers

red light at 650nm to the oral mucosa and the neck. The applicator is composed of a

connector, a fiberoptic beam of about 1 meter long and a light textile part. Appropriate

non-sterile single use disposable sleeves will be added by the operator to cover the part in

contact with the patient's mucosa or skin.

This device is CE marked and is used in this study in its intended indication.

No interim analysis is planned.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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 Criteria:

- 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.

Studien-Rationale

Primary outcome:

1. Percentage of patients with at least one OM grade >2 at any time during radiotherapy. (Time Frame - 5-10 weeks):
To investigate the efficacy of CareMin650 in the prevention of oral mucositis in patients with HNC starting radiotherapy.



Secondary outcome:

1. Frequency of AE classified using MedDRA dictionary (Time Frame - 5-10 weeks):
To investigate the safety of CareMin650

2. Grading of AE using CTCAE V5 (Time Frame - 5-10 weeks):
To investigate the safety of CareMin650

3. Number of patient with a temporary or sustains discontinuation of PBM due to AE (Time Frame - 5-10 weeks):
To investigate the safety of CareMin650

4. Time to OM lesions occurrence (Time Frame - 5-10 weeks):
To describe the patterns of OM lesions

5. Grade (WHO and CTCAE version 3) of OM lesions (Time Frame - 5-10 weeks):
To describe the patterns of OM lesions

6. Time to OM lesions resolution (defined as lesions that do not require further treatment) (Time Frame - 5-10 weeks):
To describe the patterns of OM lesions

7. Average duration of WHO grade 3 OM (Time Frame - 5-10 weeks):
To describe the duration of the grade 3 OM

8. Satisfaction of operators having use the device evaluated by a sponsor semi-quantitative satisfaction questionnaire. (Time Frame - Through study completion, an average of 1 year):
To investigate the handling and the convenience of the device from the operator's perspective

9. Satisfaction of the patient having use the device evaluated by a sponsor semi-quantitative satisfaction questionnaire. (Time Frame - Through patient study completion, an average of 2 months):
To investigate the patient satisfaction

10. Percentage of subject with onset of xerostomia during the study (Time Frame - 5-10 weeks):
To evaluate the evolution of xerostomia

11. Percentage of subject with onset of dysgeusia during the study (Time Frame - 5-10 weeks):
To evaluate the evolution of dysgeusia

12. Maximum severity of dysphagia as assessed by CTCAE V3 (Time Frame - 5-10 weeks):
To evaluate the evolution of dysphagia

13. Evolution of body weight over time (Time Frame - 5-10 weeks):
To evaluate the evolution of body weight

Geprüfte Regime

  • Photobiomodulation:
    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.

Quelle: ClinicalTrials.gov


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