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

Oral Cancer Clinical Trial

— MuciLight  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04251949
• Other study ID #: MuciLight-1903
• Secondary ID: 2020-A00976-33
• Status: Completed
• Phase: Phase 2
• Start date: March 19, 2021
• Est. completion date: September 19, 2022

Study information

• Verified date: December 2022
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 19, 2022
• Est. primary completion date: September 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cancer
• Oropharyngeal Cancer
• Oropharyngeal Neoplasms

Intervention

Procedure:
• LED photobiomodulation
1 PLED session before each radiotherapy session, until the end of the radio or radio-chemotherapy treatment. Each session will last 7 minutes. The light delivered will be preset on the lamp which will deliver a red light of a wavelength of 630nm, at a fluence of 37J/cm².

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (3)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Fondation Apicil, Santelys Association

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucositis assessment	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.	Change from baseline mucositis assessment at 7 weeks
Secondary	Pain related to the mucositis	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.	At baseline, during each session - at least 3 times a week during 7 weeks, at the end of the study (week 7)
Secondary	Starting a level 3 analgesic treatment (morphine, oxycodone, fentanyl, hydromorphone)	Percentage of patients starting a level 3 analgesic treatment during the study.	Through study completion, an average of 7 weeks
Secondary	Quality of Life (QoL)	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.	At baseline and at week 7 (end of the study)
Secondary	Modification of treatment by radiotherapy or radio-chemotherapy	Percentage of patient with an interruption (temporary or permanent) or dose modification.	Through study completion, an average of 7 weeks
Secondary	Interruption of sessions	Percentage of patient with session interruption, temporary or permanent.	Through study completion, an average of 7 weeks
Secondary	Number of side effects	Percentage of patients with side effect probably related to the photobiomodulation LED treatment.	Through study completion, an average of 7 weeks
Secondary	Nutritional support by nasogastric tube or gastrostomy tube	Percentage of patients with needs of nutritional support by nasogastric tube or gastrostomy tube.	Through study completion, an average of 7 weeks
Secondary	Weight variation	Weighting at each visit and comparison between the values	Every week during the study (7 weeks)
Secondary	Performance status	Assessment of the general condition by the scale of performance status (OMS) from 0 to 5.	Every week during the study (7 weeks)