Spots Global Cancer Trial Database for EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

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Trial Identification

Brief Title: EN3285 for the Prevention or Delay of Oral Mucositis in Patients With Head and Neck Cancer

Official Title: A Phase 3, Multi-center, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of EN3285 for the Prevention or Delay to Onset of Severe Oral Mucositis in Patients With Head and Neck Cancer Receiving Chemoradiotherapy

Study ID: NCT00574860

Conditions

Oral Mucositis

Head and Neck Cancer

Interventions

EN3285

Placebo

Standard of care

Study Description

Brief Summary: Randomized, double-blind, placebo-controlled study for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM).

Detailed Description: This randomized, double-blind, placebo-controlled study will be conducted in patients receiving chemoradiotherapy (ChemoRT) for the treatment of head and neck cancer(HNC), to assess the ability of EN3285 to prevent or delay the onset of severe oral mucositis(OM). The study includes a treatment period of up to 8 weeks, based on the patients' prescribed treatment plan, with a follow-up period of 12 months following completion of radiotherapy (RT).