Role of Antisecretory Factor in Dihydropyrimidine Treatment of Colorectal Cancer (SALFLADMET)
Dihydropyrimidine Induced Gastrointestinal Toxicity in Colorectal Cancer
About this trial
This is an interventional prevention trial for Dihydropyrimidine Induced Gastrointestinal Toxicity in Colorectal Cancer focused on measuring Dihydropyrimidine, Diarrhoea, Colorectal cancer, Antisecretory factor
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- University hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active
Control
Salovum egg powder high in antisecretory factor, 4 g/sachet. Four sachets, ie 16 g q 8 h for 6 days starting 6 days before 1st cycle of chemotherapy. SPC-flakes flat dose of 75 g/d divided in 2 - 4 doses started in parallel with Salovum to be continued during the first 8 weeks of chemotherapy.
Salovum placebo powder without antisecretory factor, 4 g/sachet. Four sachets, ie 16 g q 8 h for 6 days starting 6 days before 1st cycle of chemotherapy. SPC placebo flakes flat dose of 75 g/d divided in 2 - 4 doses started in parallel with Salovum placebo to be continued during the first 8 weeks of chemotherapy.