The FORCE Trial Pilot: Fish Oil-enriched Nutrition for Radiotherapy in Cancer of the hEad and Neck

Anna Arthur, PhD

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Head &Amp;Amp; Neck Squamous Cell Carcinoma

Treatments: Behavioral: Nutrition counseling; Drug: Fresubin Supportan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07180576

00161711

UKHSRR number: 4907 (Other Identifier)

Details and patient eligibility

About

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.

Full 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, and preliminary efficacy signals of pre- and peri-CRT fish oil-enriched drink (Fresubin Supportan) in 15 HNC patients undergoing definitive CRT. The intervention duration will be ~8.5-9 weeks (2 weeks pre-RT + ~6.5-7 weeks during CRT). The intervention includes weekly nutrition counseling from a Registered Dietitian Nutritionist (RDN) and biospecimen collection for fatty acid analysis, FADS1/2 genotyping, and long-term banking for future biomarker discovery.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Supplemental drink

Experimental group

Description:

This is a single-arm design; comparisons are pre- vs. post-intervention or against feasibility thres

Treatment:

Drug: Fresubin Supportan

Behavioral: Nutrition counseling