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

  • STATUS
    Recruiting
  • days left to enroll
    55
  • participants needed
    30
  • sponsor
    Centre Oscar Lambret
Updated on 29 October 2021
carcinoma
squamous cell carcinoma
mucositis

Summary

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.

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.

Details
Condition Oropharyngeal Cancer, carcinoma of oropharynx, Oral Cavity Cancer, oropharyngeal carcinoma, Head and Neck Cancer, head and neck cancer, oral cancers, Oral Neoplasm, cancer, oropharynx, Oral Cancer
Treatment LED photobiomodulation
Clinical Study IdentifierNCT04251949
SponsorCentre Oscar Lambret
Last Modified on29 October 2021

Eligibility

Yes No Not Sure

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
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