Status:
UNKNOWN
Role of Antisecretory Factor in Dihydropyrimidine Treatment of Colorectal Cancer
Lead Sponsor:
Uppsala University Hospital
Collaborating Sponsors:
Lantmännen AB
Sjöbergstiftelsen
Conditions:
Dihydropyrimidine Induced Gastrointestinal Toxicity in Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
One debilitating, and sometimes even life-threatening, toxicity from dihydropyrimidines, e g 5-FU and capecitabine, is gastrointestinal mucositis resulting in, eg severe diarrhoea necessitating in-hos...
Detailed Description
The pyrimidine analogue 5-fluorouracil (5-FU) has a history in oncology for more than 50 years, and is still the backbone in chemotherapy regimens, in particular for gastrointestinal cancer although i...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Histologically confirmed diagnosis of colorectal cancer.
- Planned to start 1st line dihydropyrimidine (i e 5-FU or capecitabine) based chemotherapy in the adjuvant, neoadjuvant or palliative setting.
- Planned duration of chemotherapy ≥ 2 months.
- Signed informed consent.
- Liver metastatic disease (pharmacodynamics study only).
Exclusion
- Contraindications to the investigational product, e g known or suspected hypersensitivity to the investigational products or expected inability to their use in accordance with the protocol.
- Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the investigator.
- Prior exposure to 5-FU based chemotherapy.
- Prior exposure to Salovum or SPC-flakes.
Key Trial Info
Start Date :
December 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT05339230
Start Date
December 15 2020
End Date
June 1 2025
Last Update
May 25 2022
Active Locations (1)
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1
University hospital
Uppsala, Sweden, 75185