NCT Number: NCT07180576
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 1 / Phase 2
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Two bottles per day of Fresubin Supportan, a fish oil-enriched high calorie, high protein oral nutrition supplement.
Time frame: Through study completion, approximately 18 months
Calculated as the number of participants enrolled per month during the active recruitment period. Presented descriptively
Time frame: From baseline (Week -2) to 3 months post-chemoradiotherapy
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
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
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
Assessed via structured questions during RDN visits and a final survey completed by the adult participant/caregiver.
Time frame: From baseline (Week -2) through 3 months post-chemoradiotherapy
The key safety endpoint. Calculated as the proportion of enrolled participants who discontinue the supplement due to an AE deemed at least possibly related to the supplement. A 95% binomial CI will be calculated for this proportion. The point estimate and CI will be compared to the pre-defined success threshold of <15%.
Time frame: From baseline (Week -2) to 3 months post-chemoradiotherapy
Skeletal Muscle Index as assessed using diagnostic CT images with sliceomatic software.
Time frame: From baseline (Week -2) to 3 months post-chemoradiotherapy
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
Changes in key red blood cell (RBC) fatty acid levels (EPA, DHA, Arachidonic Acid, EPA:AA ratio)
Time frame: Baseline
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.
Contact information is provided by the study sponsor or research team.
Anna Arthur, PhD
CONTACT
Gregory Gan, PhD, MD
CONTACT
Anna Arthur, PhD
Other
The FORCE Trial Pilot
Acronym: FORCE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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