Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Oral Cancer
- Oropharyngeal Cancer
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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. O...
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.
Tracking Information
- NCT #
- NCT04251949
- Collaborators
- Fondation Apicil
- Santélys
- Investigators
- Principal Investigator: Xavier XL LIEM, MD Centre Oscar Lambret