Background Low-level laser therapy (LLLT) also called Photobiomodulation therapy (PBMT) could reduce oral mucositis (OM) incidence and severity in head and neck cancer patients treated by chemoradiotherapy, however randomised data about efficacy and safety are missing with curative dose 4 J/cm 2 . Methods This phase III trial was conducted in patients with oral cavity, or oro/hypopharyngeal cancers (stage III or IV). Patients were treated by lasertherapy on OM lesions grade ≥ 2 (4 J/cm 2 or placebo), during chemoradiotherapy and until recovery. Severity of OM (incidence and duration of grades ≥3) was used as primary endpoint and blindly assessed. Results Among 97 randomised patients, 83 patients (85.6%) could be assessed finally (erroneous inclusions, chemoradiotherapy interruptions) and 32 patients had no lasertherapy because of unreachable OM lesions. Randomisation and population characteristics (sex ratio, age, chemoradiotherapy procedures, toxicities incidence) were still comparable between the two LLLT/PBMT groups. An acute OM (grade ≥ 3) was observed in 41 patients (49.4%): 23 patients (54.8%) of the active laser group versus 18 (43.9%) in the control group (modified intend to treat, p = 0.32). Median time before occurrence of OM ≥ grade 3 in half of the patients was 8 weeks in active laser group (vs. 9 weeks in control group). However, 95% of patients exhibited a very good tolerance of LLLT/PBMT. Conclusions This study assessed LLLT/PBMT according to the Multinational Association of Supportive care in Cancer recommendations but lacked power. LLLT/PBMT was well tolerated with a good safety profile, which promotes its use in clinical routine for severe OM treatment. Trial registration ClinicalTrials.gov Identifier: NCT01772706 . Title: Laser Mucite ORL: Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (LaserMucite). Study Start Date: October 2008. Primary Completion Date: October 2016. Responsible Party: Institut de Cancérologie de l’Ouest – Paul Papin. Principal Investigator: Eric Jadaud, M.D., Institut de Cancérologie de l’Ouest – Paul Papin. Funding: French Ministry of Health, French national funding scheme (PHRC 2008).
Abstract. Many human communities living in coastal areas in Africa and Asia rely on thin freshwater lenses for their domestic supply. Population growth together with change in rainfall patterns and sea level will probably impact these vulnerable groundwater resources. Spatial knowledge of the aquifer properties and creation of a groundwater model are required for achieving a sustainable management of the resource. This paper presents a ready-to-use methodology for estimating the key aquifer properties and the freshwater resource based on the joint use of two non-invasive geophysical tools together with common hydrological measurements.We applied the proposed methodology in an unconfined aquifer of a coastal sandy barrier in South-Western India. We jointly used magnetic resonance and transient electromagnetic soundings and we monitored rainfall, groundwater level and groundwater electrical conductivity. The combined interpretation of geophysical and hydrological results allowed estimating the aquifer properties and mapping the freshwater lens. Depending on the location and season, we estimate the freshwater reserve to range between 400 and 700 L m −2 of surface area (± 50 %). We also estimate the recharge using time lapse geophysical measurements with hydrological monitoring. After a rainy event close to 100 % of the rain is reaching the water table, but the net recharge at the end of the monsoon is less than 10 % of the rain. Thus, we conclude that a change in rainfall patterns will probably not impact the groundwater resource since most of the rain water recharging the aquifer is flowing towards the sea and the river. However, a change in sea level will impact both the groundwater reserve and net recharge.
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