The FORCE Trial Pilot: Fish Oil-enriched Nutrition for Radiotherapy in Cancer of the hEad and Neck
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnna Arthur, PhD
About this trial
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 and neck cancer (HNC) undergoing curative-intent chemoradiotherapy (CRT) at the University of Kansas Medical Center. The study involves daily supplementation starting two weeks prior to CRT and continuing throughout CRT, alongside weekly nutrition counseling.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Nutrition counseling
- Fresubin Supportan
Treatment groups
15 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Anna Arthur, PhD
Lead sponsor
University of Kansas Medical Center
Sponsor institution
Fresenius Kabi
Collaborator
Source ClinicalTrials.gov