Therapy-associated diarrhea during radiation therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy) is a common problem in multimodal cancer therapy. We investigate the therapeutic effect of either loperamide or tinctura opii in therapy- associated diarrhea in patients who receive radiation therapy of the small pelvis with or without chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
After beginning of diarrhea grade 1: 5 drops tincture of opium three times a day After beginning of diarrhea grade 2: Intensive therapy with 15 drops tincture of opium three times a day.
All patients who receive as a result of randomisation loperamide After beginning of diarrhea grade 1: Initial 4mg and 2mg after any unformed stool. The maximum dose amounts to16mg per day. After beginning of diarrhea grade 2: Intensive therapy with 2mg loperamide every 2 h. The maximum dose amounts to 16mg per day.
Treatment Efficacy
In this study efficacy of loperamide and tincture of opium is linked to the respective proportions of patients where diarrhoea of grade \> 2 is successfully averted during (cancer) therapy.
Time frame: 90 days
Quality of life EORTC-QLQ C30
Quality of life will be assessed with the EORTC-QLQ C30 questionnaire
Time frame: 90 days
Diarrhea Assessment
The quality and quantity of diarrhea will be assessed with a questionnaire
Time frame: 90 days
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