Recruitment

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