Cancer, Diarrhea, Enteritis
Conditions
Keywords
radiation therapy, diarrhea, enteritis, supportive therapy, therapy associated diarrhea, therapy associated enteritis, radiation therapy of the small pelvis
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.
Interventions
DRUGOpii normata treatment
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.
DRUGLoperamid Treatment
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.
Sponsors
Maros Arznei GmbH
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Comparision between treatment with Tinctura Opii normata and Loperamid in patients with therapy-associated diarrhea during radiaton therapy of small pelvis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patients who will undergo a percutaneous radiation therapy in the area of the small pelvis. This includes patients with following malignancies: rectal carcinoma, prostate carcinoma, endometrial carcinoma, cervix carcinoma. * Diarrhea grade 1 and grade 2 (Classification NCI-CTCAE Version 3.0) * ECOG-Grade 0-2 * Enlightenment and written declaration of consent to the participation.
Exclusion criteria
* Pregnant patients or patients in lactation period. * Severe dysfunction of liver or kidneys * Injury or illness of brain e.g. increased intracranial pressure, cerebral arteriosclerosis * Epilepsy * Hypersensitivity to components of loperamide or tincture of opium * Ileus * Toxic megacolon * Pseudomembranous colitis/ antibiotic-associated colitis * Diarrhea associated with fever and bloody stools * Acute increase of colitis ulcerous or bacterial colitis caused by invasive pathogenes * Severe respiratory dysfunction or severely limited lung function e.g. bronchial asthma, bronchitis * Dysfunctional draining of biliary area, biliary colics. * Concomitant or earlier addiction of alcohol or opiates * Severe heart disease * Pheochromocytoma * Acute hepatic porphyria * Cor pulmonale * Morbus Addison * Severe hypothyroidism * Organisational problems or circumstances which prevent a complete collection of required data * Artificial anus * Participation in a clinical trial within the last 30 days before involvement * Participation in an other clinical trial at the same time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Efficacy | 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life EORTC-QLQ C30 | 90 days | Quality of life will be assessed with the EORTC-QLQ C30 questionnaire |
| Diarrhea Assessment | 90 days | The quality and quantity of diarrhea will be assessed with a questionnaire |
Outcome results
None listed