Using Antisecretory Factor to Reduce Diarrhea from Colorectal Cancer Treatment
A Randomized Phase 2 and Pilot Pharmacodynamic Trial Investigating the Effect of Salovum™ and SPC-flakes on Dihydropyrimidine Induced Gastrointestinal Toxicity and Tumour Perfusion in Colorectal Cancer
This study is testing whether a treatment made from egg yolk can help colorectal cancer patients reduce severe diarrhea caused by their chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uppsala University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Uppsala) |
| Trial ID | NCT05339230 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of Antisecretory Factor (ASF) in mitigating gastrointestinal toxicity caused by dihydropyrimidine chemotherapy agents like 5-FU and capecitabine in colorectal cancer patients. The trial will assess the efficacy of ASF, derived from spray-dried egg yolk, in preventing severe diarrhea, a common and debilitating side effect of these treatments. Participants will receive either ASF or a placebo while undergoing chemotherapy, with the aim of improving their quality of life and reducing the need for hospital care. The study is crucial as current treatments for this toxicity are only moderately effective.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of colorectal cancer who are about to start their first line of dihydropyrimidine-based chemotherapy.
Not a fit: Patients who have previously been treated with 5-FU or have contraindications to the investigational products may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce gastrointestinal toxicity and improve the quality of life for colorectal cancer patients undergoing chemotherapy.
How similar studies have performed: While the use of ASF is a novel approach, similar studies targeting gastrointestinal toxicity in cancer treatment have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically confirmed diagnosis of colorectal cancer. 3. Planned to start 1st line dihydropyrimidine (i e 5-FU or capecitabine) based chemotherapy in the adjuvant, neoadjuvant or palliative setting. 4. Planned duration of chemotherapy ≥ 2 months. 5. Signed informed consent. 6. Liver metastatic disease (pharmacodynamics study only). Exclusion Criteria: 1. 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. 2. Lack of suitability for participation in the study, e g expected difficulties to follow the protocol procedures, as judged by the investigator. 3. Prior exposure to 5-FU based chemotherapy. 4. Prior exposure to Salovum or SPC-flakes.
Where this trial is running
Uppsala
- University hospital — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Peter Nygren, MD
- Email: peter.nygren@igp.uu.se
- Phone: +46 70 4250719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.