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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00976-33 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Fondation Apicil | OTHER |
| Santelys Association | OTHER |
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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LED photobiomodulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier XL LIEM, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | 59020 | France |
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| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D052016 | Mucositis |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
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| 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 |
| 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) |
| 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 |
| Interruption of sessions | Percentage of patient with session interruption, temporary or permanent. | Through study completion, an average of 7 weeks |
| 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 |
| 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 |
| Weight variation | Weighting at each visit and comparison between the values | Every week during the study (7 weeks) |
| 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) |
| D009057 |
| Stomatognathic Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |