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

Sponsor

Centre Oscar Lambret (Other)

Overall Status

Recruiting

CT.gov ID

NCT04251949

Collaborator

Fondation Apicil (Other), Santelys Association (Other)

Enrollment

Location

19.4

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Oral Cancer Oropharyngeal Cancer	Procedure: LED photobiomodulation	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Evaluation of Photobiomodumation Using LED Lamp as a Curative Treatment for Oral or Oropharyngeal Mucositic Inducted by Radiation Therapy

Actual Study Start Date :

Mar 19, 2021

Anticipated Primary Completion Date :

May 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Outcome Measures

Primary Outcome Measures

Mucositis assessment [Change from baseline mucositis assessment at 7 weeks]
The mucositis will be assessed at least once a week between the inclusion and the end of treatment by radiotherapy or radio-chimiotherapy. It will be graded according to the NCI-CTCAE v5 scale. The scale ranging from 1 to 5. Where 1 is mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated and where 5 is death related to adverse event. We will consider as success the non-occurrence of stage 3 or higher mucositis between the inclusion and the end of radiotherapy. All patient presenting stage 3 or higher mucositis, which means, aphagia leading to an indication of nutritional support between the inclusion and the end of radiotherapy will be considered as a failure. A patient receiving less than 60 grey for an other reason than mucositis will be concidered as not assessable for the primery outcome.

Secondary Outcome Measures

Pain related to the mucositis [At baseline, during each session - at least 3 times a week during 7 weeks, at the end of the study (week 7)]
Pain will be assessed with a decimal numerical scale (END) from 0 to 10. Where 0 is no pain felt and 10 is the maximal pain felt. An estimation of the average difference between each mesure will be performed.
Starting a level 3 analgesic treatment (morphine, oxycodone, fentanyl, hydromorphone) [Through study completion, an average of 7 weeks]
Percentage of patients starting a level 3 analgesic treatment during the study.
Quality of Life (QoL) [At baseline and at week 7 (end of the study)]
The quality of life will be evaluated using the EORTC-QLQ-C30 questionnaire. This questionnaire aim to assess the quality of life of cancer and it's composed of 30 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much. Only 2 items in the EORTC-QLQ-C30 questionnaire are scored from 1-7, where 1 is very poor and 7 is excellent. After that, questions from 31 to 65 are about H&N35, still to assess the quality of life of cancer. The items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much. Only 5 items are scored from 1-2, where 1 = No and 2 = Yes.
Modification of treatment by radiotherapy or radio-chemotherapy [Through study completion, an average of 7 weeks]
Percentage of patient with an interruption (temporary or permanent) or dose modification.
Interruption of sessions [Through study completion, an average of 7 weeks]
Percentage of patient with session interruption, temporary or permanent.
Number of side effects [Through study completion, an average of 7 weeks]
Percentage of patients with side effect probably related to the photobiomodulation LED treatment.
Nutritional support by nasogastric tube or gastrostomy tube [Through study completion, an average of 7 weeks]
Percentage of patients with needs of nutritional support by nasogastric tube or gastrostomy tube.
Weight variation [Every week during the study (7 weeks)]
Weighting at each visit and comparison between the values
Performance status [Every week during the study (7 weeks)]
Assessment of the general condition by the scale of performance status (OMS) from 0 to 5.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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