Clinical Trial: Prospective Randomized Open Label Study of the Treatment of Therapy-Associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Prospective Randomized Open Label Study of the Treatment of Therapy-Associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium
Brief Summary: 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.
Detailed Summary:
Sponsor: Philipps University Marburg Medical Center
Current Primary Outcome:
- 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.
- Should diarrhoea of grade > 2 occur despite the respective drug treatment, the corresponding medicament is assessed as inefficacious in that case.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Scores from the EORTC-QLQ-C30
- Body composition data (BMI, proportions of fat and water
Original Secondary Outcome: Same as current
Information By: Philipps University Marburg Medical Center
Dates:
Date Received: March 6, 2007
Date Started: September 2007
Date Completion:
Last Updated: August 31, 2007
Last Verified: August 2007
