Oral Cancer, Oropharyngeal Cancer
Conditions
Keywords
Oral cancer, Radiotherapy, Radio-chemotherapy, Mucositis, LED photobiomodulation (PLED), Oropharyngeal cancer
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.
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.
Interventions
PROCEDURELED 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.
Sponsors
Centre Oscar Lambret
Fondation Apicil
Santelys Association
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORXavier XL LIEM, MD
Centre Oscar Lambret
Outcome results
None listed