Status:
NOT_YET_RECRUITING
The FORCE Trial Pilot: Fish Oil-enriched Nutrition for Radiotherapy in Cancer of the hEad and Neck
Lead Sponsor:
Anna Arthur, PhD
Collaborating Sponsors:
Fresenius Kabi
Conditions:
Head &Amp;Amp; Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
en-label, proof-of-concept study designed to evaluate the feasibility, safety, and acceptability of a prophylactic fish oil-enriched nutritional supplement (Fresubin Supportan) in patients with head a...
Detailed Description
This will be a single-arm, open-label, proof-of-concept (PoC) study conducted at the University of Kansas Medical Center (KUMC). The overarching goal is to assess feasibility, safety, acceptability, a...
Eligibility Criteria
Inclusion
- Newly diagnosed with Stage I - IV oral cavity, hypopharyngeal, oropharyngeal, or laryngeal cancer
- Age 18+
- Planned for definitive radiotherapy with or without surgery and chemotherapy
Exclusion
- Metastatic disease
- Prior head/neck RT
- Presence of malnutrition at diagnosis per ASPEN criteria
- Prior cancer within 3 years (except non-melanoma skin cancer and cervical carcinoma in situ)
- Inability to consent
- Severe psychiatric illness
- Medical conditions impairing participation/adherence
- Non-adults, pregnant women, prisoners, and other legally protected vulnerable groups
- Dairy, soy, and/or fish allergy
- Non-English speaking
- Documented history of atrial fibrillation or other significant arrhythmias
- Receiving therapeutic anticoagulation (e.g., warfarin, direct oral anticoagulants) and/or clotting disorders (e.g., hemophilia, thrombocytopenia)
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07180576
Start Date
January 1 2026
End Date
December 31 2027
Last Update
September 18 2025
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