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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Head &Amp;Amp; Neck Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Supplemental drink

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

Group Type EXPERIMENTAL

Nutrition counseling

Intervention Type BEHAVIORAL

Weekly standardized nutrition counseling will be provided by a study RDN to promote adherence and address barriers to adherence, acceptability, and adverse events. The RDN will also document any changes to the CRT regimen and hospitalizations.

Fresubin Supportan

Intervention Type DRUG

Two bottles per day of Fresubin Supportan, a fish oil-enriched high calorie, high protein oral nutrition supplement.

Interventions

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Nutrition counseling

Weekly standardized nutrition counseling will be provided by a study RDN to promote adherence and address barriers to adherence, acceptability, and adverse events. The RDN will also document any changes to the CRT regimen and hospitalizations.

Intervention Type BEHAVIORAL

Fresubin Supportan

Two bottles per day of Fresubin Supportan, a fish oil-enriched high calorie, high protein oral nutrition supplement.

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No