A Phase 3 interventional study of Opii normata treatment and Loperamid Treatment in Diarrhea, Enteritis and Cancer, sponsored by Philipps University Marburg. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by Philipps University Marburg · Phase 3, Interventional, and Treatment
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's enrollment of 1 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Philipps University Marburg is the lead sponsor of 116 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treamtment with opii normata in case of diarrhea
Drug: Opii normata treatment
Treatment with Loperamid in case of diarrhea
Drug: Loperamid 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.
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
No study locations are listed for this record.
Ran from Mar 2007 to primary completion in Feb 2008, 11 months.
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This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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