Therapy-associated diarrhea during radiaton therapy of small pelvis (including enteritis as a result of radiation therapy and enteritis as a result of radiation- and chemotherapy). MedDRA version: 8.1 Level: LLT Classification code 10012735 Term: Diarrhoea
Conditions
Interventions
Product Name: Tinctura Opii normata DAB 2003
Pharmaceutical Form: Oral drops*
INN or Proposed INN: tinctura opii normata DAB
CAS Number: 8013603
Other descriptive name: opium tinkture standardised, Ei
Sponsors
MAROS Arzneimittel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 • Pseudmembraneous colitis/ antibiotic-associated colitis • Diarrhea associated with fever and bloody stools • Acute increase of colitis ulcerosa 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 hypothyreoidism • 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 inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Primary Endpoint: In this study efficacy of loperamide and tincture of opium is linked to the respective proportions of patients where diarrhea of grade > 2 is successfully averted during (cancer) therapy. Should diarrhoea of grade > 2 occur despite the respective drug treatment, the corresponding drug treatment is assessed as ineffective in that case und the patient is defined as non-responder. Secondary Endpoints: - Scores from the EORTC-QLQ-C30 - Body composition data (BMI, proportions of fat and water) ;Main Objective: 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 drug treatment is assessed as ineffective in that case und the patient is defined as non-respomder. ;Secondary Objective: - Scores from the EORTC-QLQ-C30 - Body composition data (BMI, proportions of fat and water) | — |
Countries
Germany
Outcome results
None listed