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

ConditionHead &Amp;Amp; Neck Squamous Cell Carcinoma
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Nutrition counseling

    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

    Drug

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

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Supplemental drinkExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Recruitment rate

Calculated as the number of participants enrolled per month during the active recruitment period. Presented descriptively

Time frame
Through study completion, approximately 18 months
2

Adherence Rate

The primary feasibility endpoint. Calculated as the proportion of enrolled participants who consume ≥75% of the prescribed supplement doses (2 bottles/day) throughout the intervention period, based on participant/caregiver tracking logs.

Time frame
From baseline (Week -2) to 3 months post-chemoradiotherapy
3

Retention Rate

Calculated as the proportion of enrolled participants who complete the intervention phase (through end of CRT) and the proportion who complete the 3-month post-CRT follow-up visit.

Time frame
From baseline (Week -2) to 3 months post-chemoradiotherapy
4

Adverse Events

Adverse event (AEs) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. Frequencies and percentages of all reported AEs will be tabulated by type, severity (CTCAE v5.0 grade), and investigator-assessed relatedness to the study supplement (Fresubin Supportan).

Time frame
From baseline (Week -2) to 3 months post-chemoradiotherapy

Secondary outcomes

1

Body composition

Skeletal Muscle Index as assessed using diagnostic CT images with sliceomatic software.

Time frame
From baseline (Week -2) to 3 months post-chemoradiotherapy
2

Nutrition Impact Symptoms

Change in patient-reported NIS will be assessed using the MDASI-HN total symptom severity score and relevant subscale scores.

Time frame
From baseline (Week -2) to 3 months post-chemoradiotherapy
3

Red Blood Cell Fatty Acid Profiles

Changes in key red blood cell (RBC) fatty acid levels (EPA, DHA, Arachidonic Acid, EPA:AA ratio)

Time frame
From baseline (Week -2) to 3 months post-chemoradiotherapy
4

FADS1/2 Genotyping

FADS1/2 Genotyping: Genotype frequencies (I/I, I/D, D/D for rs66698963) and allele frequencies (I allele, D allele) will be calculated and reported descriptively for the baseline samples. Exploratory analyses may examine outcomes stratified by genotype, but these will be hypothesis-generating only due to the small N.

Time frame
Baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Anna Arthur, PhD

Lead sponsor

University of Kansas Medical Center

Sponsor institution

Fresenius Kabi

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: