Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis. (MuciLight)

Centre Oscar Lambret

Status and phase

Completed

Phase 2

Conditions

Oropharyngeal Cancer

Oral Cancer

Treatments

Procedure: LED photobiomodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT04251949

MuciLight-1903

2020-A00976-33 (Other Identifier)

Details and patient eligibility

About

This is a monocentric, prospective, non-comparative phase II study with minimal risks and constraints. The study will aim to assess the curative treatment of radio-induced mucositis by photobiomodulation using LED lamp.

Full description

The aim of this study is to assess the effectiveness of the treatment of radio- or radio-chemotherapy-induced early stage mucositis (stage 1 and 2) by photobiomodulation using LED lamp (PLED) in terms of controlling the mucositis assessed at the end of radiotherapy or radio-chemotherapy treatment.

Other objectives of the study include:

To assess the pain evolution over-time, both overall over the evaluation period until the end of radiotherapy and at each session
To assess the needs of level 3 analgesics (morphine, oxycodone, fentanyl, hydromorphone) during the PLED protocol.
To assess the quality of life variation between inclusion and the end of treatment by radiotherapy or radio-chemotherapy.
To estimate the frequency of radiotherapy or radio-chemotherapy treatment (temporary or permanent interruption, dose modification), and eventually, the reason of this modification.
To assess the feasibility of photobiomodumation by LED (PLED) in this context.
To assess the tolerability of photobiomodumation by LED (PLED) in a short term.
To assess the frequency of the needs of nutritional support by nasogastric tube or gastrostomy tube during the PLED protocol.
To assess the weight and general condition variation during the treatment.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 years old
With squamous cell carcinoma of the head and/or neck
Stage 1 or 2 mucositis (NCI-CTCAE v5), wich means a mucositis not requiring an enteral nutrition management (solid or liquid alimentation possible, including with feed supplements) in week 2 to 4 in relation to the beginning of radiotherapy.
During treatment by radiotherapy, with or without concomitant chemotherapy
Patient affiliated to a social security system
Patient who signed the informed consent for this study

Exclusion criteria

Radiotherapy treatment completed
Stage 3 or higher mucositis already installed
History of skin porphyria or lupus erythematosus
Concomitant or within 7 days prior to inclusion, at least one of following drugs : fluoroquinolones, cycline, methotrexate, auranofine
Enteral nutrition support in progress
Pregnant or breast-feeding woman
Patient under guardianship or curatorship