Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-24 @ 11:18 PM
NCT ID:
NCT03988556
Brief Summary:
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.
Detailed Description:
The main objective of the present study is to investigate the feasibility, safety and tolerability of CareMin650 in patients with 1) head \& neck cancer at high risk of or suffering from oral mucositis and/or radiation dermatitis due to the administration of radiotherapy with or without chemotherapy with or without targeted therapy, 2) breast cancer at high risk of or suffering from radiation dermatitis due to the administration of radiotherapy.
This is a prospective non-comparative study. Two cohorts of patients will be included, based on the tumour location. Each cohort will be divided into two subgroups according to whether the treatment is for curative or preventive purposes.
* Patients with head \& neck cancer (cohort A), either starting radiotherapy with or without chemotherapy with or without targeted therapy (no lesions, prophylactic intent, cohort A1) or having started treatment and presenting with grade 1 to 3 lesions of oral mucositis and/or radiation dermatitis (curative intent, cohort A2).
* Patients with breast cancer requiring radiation therapy (cohort B), either starting radiation therapy (i.e. no lesions, prophylactic intent, cohort B1) or having started treatment and presenting with grade 1 to 3 lesions of radiation dermatitis (curative intent, cohort B2) it is planned to select a maximum number of 72 patients (36 in each cohort)
Consecutive patients will be included in each of the four predefined subgroups, until the target number of patients in each subgroup has been reached.
The photobiomodulation treatment will be initiated at inclusion and will be continued for the duration of radiotherapy (6 to 8 weeks maximum).
The maximum total participation in the study is anticipated to be approximately ten weeks for each patient.
Study:
NCT03988556
Study Brief:
Protocol Section:
NCT03988556