Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis. (MuciLight)
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|ClinicalTrials.gov Identifier: NCT04251949|
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : May 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oral Cancer Oropharyngeal Cancer||Procedure: LED photobiomodulation||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||August 2021|
- 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.
- Mucositis assessment [ Time Frame: 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.
- Pain related to the mucositis [ Time Frame: 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) [ Time Frame: Through study completion, an average of 7 weeks ]Percentage of patients starting a level 3 analgesic treatment during the study.
- Quality of Life (QoL) [ Time Frame: 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 [ Time Frame: Through study completion, an average of 7 weeks ]Percentage of patient with an interruption (temporary or permanent) or dose modification.
- Interruption of sessions [ Time Frame: Through study completion, an average of 7 weeks ]Percentage of patient with session interruption, temporary or permanent.
- Number of side effects [ Time Frame: 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 [ Time Frame: Through study completion, an average of 7 weeks ]Percentage of patients with needs of nutritional support by nasogastric tube or gastrostomy tube.
- Weight variation [ Time Frame: Every week during the study (7 weeks) ]Weighting at each visit and comparison between the values
- Performance status [ Time Frame: Every week during the study (7 weeks) ]Assessment of the general condition by the scale of performance status (OMS) from 0 to 5.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251949
|Contact: Marie MV VANSEYMORTIERfirstname.lastname@example.org|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Contact: Marie MV VANSEYMORTIER 0320295935 email@example.com|
|Contact: Xavier XL LIEM, MD 0320295935 firstname.lastname@example.org|
|Principal Investigator: Xavier XL LIEM, MD|
|Sub-Investigator: Geoffrey GM MARTINAGE, MD|
|Sub-Investigator: Xavier XM MIRABEL, MD|
|Sub-Investigator: David DP PASQUIER, MD|
|Principal Investigator:||Xavier XL LIEM, MD||Centre Oscar Lambret|