Purpose ;Diarrhea is The most common manifestation of acute damage caused by radiation therapy that effective treatment remains unclear. In this study, we compare product derived from plantago ovata with standard drug loperamide in the treatment of diarrhea caused by radiotherapy.
Design of study and performance: This study is open randomized clinical trial with control group (standard drug) in one center (Motahari Clinic) that perform On patients with histologically confirmed cancer and age> 18 years that experienced diarrhea with grade 1(Increase of <4 stools per day over baseline),grade 2(Increase of 4 - 6 stools per day over baseline) to grade3( increase of >=7-10 stools per day over baseline or stool incontinence), as described in Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, after at least a fraction of radiotherapy. The main exclusion criteria are diarrhea or stool incontinence before the beginning of irradiation, grade 4 diarrhea, past history of gastrointestinal disorder known to cause diarrhea. 62 Samples select from target population that assign at least 31patients to each of two treatment arms. Patients randomly assign to receive either loperamide in a standard dosage or traditional drug ,paste product, two times daily for one week. All patients give a diary and instruct to record the daily medication taken, the number of loose bowel movements, occurrence of blood or mucus in stool, Duration of diarrhea therapy starting from the first day of administration of the study drug until complete disappearance of loose bowel movements and side effects of drugs on each treatment day. Follow up of every patient perform on a daily basis during the course of treatment by a therapist on the phone. The primary outcome assess as follows : complete response _complete resolution of diarrhea, partial response _ one to two diarrheas daily, no response _ three or more diarrheas daily.