Esofagitis esophagusinflammation
Conditions
Interventions
108 patients eligible for this study will be monitored during their (N)SCLC
chemo/radiotherapy treatment. One group of 72 patients will receive Caphosol®,
4 times a day - next to the standard of car
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 18 years or older Patients with histologically proven (N)SCLC (all histological subtypes), treated with concurrent chemo- and radiotherapy.
Exclusion criteria
Exclusion criteria: Concurrent participation in a clinical trial in which the subject is taking or receiving any investigational agent that may affect the frequency, severity or duration of mucositis. Pre-existent esophagitis. Receiving investigational treatment for the prevention or treatment of mucositis. Prior irradiation to the lung or head and neck region.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to estimate the incidence, onset, duration and severity of esophagitis in SCLC patients undergoing radiation therapy with chemotherapy who receive Caphosol®. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To correlate components of esophagitis data with clinical outcomes (pain, dysphagia, analgetic use, oral intake, weight loss, infection, need for hospitalization, QoL) 2. Discontinuation or delay of chemotherapy due to esophagitis. | — |
Countries
Netherlands
Outcome results
None listed