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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00008547 |
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Date of registration:
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27/05/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of supplementary feeding on the side effects associated with cancer therapy with Oxaliplatin or Irinotecan
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Scientific title:
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Effect of supplementary feeding on the side effects associated with cancer therapy with Oxaliplatin or Irinotecan - Oxa-Iri-EVENTS |
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Date of first enrolment:
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16/06/2015 |
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Target sample size:
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750 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00008547 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Hayssam
Zakaria |
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Address:
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Bödekerstr. 22
30161
Hannover
Germany |
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Telephone:
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0511 76355 123 |
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Email:
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info@n-c-o.de |
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Affiliation:
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NewConceptOncology GmbH |
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Name:
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Detlev
Schröder |
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Address:
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Karl-Wiechert-Allee 1A
30625
Hannover
Germany |
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Telephone:
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0511-5547383 |
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Email:
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schroeder@onkologiehannover.de |
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Affiliation:
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Gemeinschaftspraxis Schröder/Kamahl |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patient:
- adults capable to consent (> 18 years)
Exclusion criteria: Patients under 18 years , pregnant women , patients uncapable to consent
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ascending colon
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C18
C18.1
C18.2
C18.3
C18.4
C18.5
C18.6
C18.7
C18.8
C18.9
C19
C20
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C18.2
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C18.5
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C18.8
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Colon, unspecified
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Splenic flexure
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C18.1
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C18.4
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Hepatic flexure
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C18.7
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Transverse colon
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Malignant neoplasm of colon
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Appendix
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C18.3
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C18.6
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C18.9
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Malignant neoplasm of rectosigmoid junction
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Malignant neoplasm of rectum
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Overlapping lesion of colon
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Descending colon
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Sigmoid colon
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Intervention(s)
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Group 1: In this single-arm medicament study the role of nutrition should be studied in the side effects of Oxaliplatin / Irinotecan with a particular in a relatively large group of patients.
Riboxatin = Oxaliplatin
Riboirino = Irinotecan
Dose strength: Riboxatin 5mg/ml, Riboirino 20mg/ml
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Primary Outcome(s)
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The influence of the nutritional status of patients on the severity of the side effects of treatment with oxaliplatin or irinotecan (Riboxatin® or Riboirino®).
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Secondary Outcome(s)
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Influence of other dietary supplements on the side effects of treatment with oxaliplatin or irinotecan. (Riboxatin® or Riboirino®)
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Secondary ID(s)
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U1111-1170-4369
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Source(s) of Monetary Support
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ribosepharm division - Hikma Pharma GmbH
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Ethics review
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Status: Approved
Approval date: 17/03/2015
Contact:
ethikkommission@aekn.de
Ethikkommission bei der Ärztekammer Niedersachsen, Unterkommission zur Beurteilung medizinischer Forschung am Menschen
+49-511-3802208
ethikkommission@aekn.de
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