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Not Yet Recruiting PHASE1, PHASE2 INTERVENTIONAL NCT07180576

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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.

Detailed 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.

Interventions

Name: Nutrition counseling
Type: BEHAVIORAL
Description: 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.
Name: Fresubin Supportan
Type: DRUG
Description: Two bottles per day of Fresubin Supportan, a fish oil-enriched high calorie, high protein oral nutrition supplement.

Primary Outcomes

Measure: Recruitment rate
TimeFrame: Through study completion, approximately 18 months
Description: Calculated as the number of participants enrolled per month during the active recruitment period. Presented descriptively
Measure: Adherence Rate
TimeFrame: From baseline (Week -2) to 3 months post-chemoradiotherapy
Description: 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.
Measure: Retention Rate
TimeFrame: From baseline (Week -2) to 3 months post-chemoradiotherapy
Description: 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.
Measure: Adverse Events
TimeFrame: From baseline (Week -2) to 3 months post-chemoradiotherapy
Description: 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).
Measure: Supplement Acceptability
TimeFrame: From baseline (Week -2) to 3 months post-chemoradiotherapy
Description: Assessed via structured questions during RDN visits and a final survey completed by the adult participant/caregiver.
Measure: Supplement Discontinuation due to AEs
TimeFrame: From baseline (Week -2) through 3 months post-chemoradiotherapy
Description: 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%.

Trial Information

NCT ID

NCT07180576

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1, PHASE2

Sponsor

Anna Arthur, PhD

Last Updated

December 15, 2025