Using egg powder to improve outcomes in glioblastoma patients
Antisecretory Factor During Concomitant and Adjuvant Therapy of Primary Glioblastoma, a Randomised, Prospective and Double Blinded Study
PHASE2; PHASE3 · Skane University Hospital · NCT05669820
This study is testing if a special egg powder can help people with newly diagnosed glioblastoma live longer and improve their treatment outcomes when taken during their therapy.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Skane University Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lund) |
| Trial ID | NCT05669820 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial investigates the effects of an egg powder enriched with antisecretory factor (AF) on patients with newly diagnosed glioblastoma. Participants will be randomly assigned to receive either the AF-enriched egg powder, Salovum, or a placebo daily, starting two days before their scheduled radiochemotherapy and continuing through the treatment period. The primary objective is to assess overall survival rates at 6 and 12 months post-diagnosis, leveraging the potential anti-inflammatory and antisecretory properties of AF to enhance treatment efficacy. The study aims to address the challenges posed by elevated interstitial fluid pressure in glioblastoma, which can hinder drug delivery and treatment effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with pathology-verified glioblastoma or astrocytoma grade 4 who are scheduled for surgical treatment followed by radiochemotherapy.
Not a fit: Patients who have only undergone surgical biopsy or those with an egg yolk allergy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates for glioblastoma patients.
How similar studies have performed: While the use of antisecretory factors in glioblastoma treatment is novel, previous studies have shown promising results in animal models, indicating potential for success in human trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Pathology verified glioblastoma or astrocytoma grade 4 2. Age 18-75 years 3. Surgical treatment-resection. 4. Scheduled concomitant radiochemotherapy, or only chemotherapy. 5. Informed consent Exclusion Criteria: 1. No informed consent 2. Egg yolk allergy 3. Only surgical biopsy 4. Only radiotherapy
Where this trial is running
Lund
- Skåne University Hospital — Lund, Sweden (RECRUITING)
Study contacts
- Study coordinator: Peter Siesjö, MD, PhD
- Email: peter.siesjo@med.lu.se
- Phone: +4646171274
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.
Conditions: Glioblastoma, Antisecretory factor, Trials, Randomized Clinical