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

NCT07180576 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 00161711UKHSRR number: 4907
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Head &Amp;Amp; Neck Squamous Cell Carcinoma

Keywords

nutrition; head and neck cancer; nutrition supplement; nutrition trial; fish oil; cancer patient; sarcopenia; nutrition impact symptoms; body composition; cancer; oncology; fatty acid; cancer survivor; oral nutrition supplement; supportive care

Outcome Measures

Primary Outcomes (6)

• Recruitment rate

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

  Through study completion, approximately 18 months

• 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.

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

• 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.

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

• 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).

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

• Supplement Acceptability

  Assessed via structured questions during RDN visits and a final survey completed by the adult participant/caregiver.

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

• Supplement Discontinuation due to AEs

  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%.

  From baseline (Week -2) through 3 months post-chemoradiotherapy

Secondary Outcomes (4)

• Body composition

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

• Nutrition Impact Symptoms

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

• Red Blood Cell Fatty Acid Profiles

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

• FADS1/2 Genotyping

  Baseline

Study Arms (1)

Supplemental drink

EXPERIMENTAL

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

Behavioral: Nutrition counseling; Drug: Fresubin Supportan

Interventions

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.

Supplemental drink

Fresubin Supportan DRUG

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

Supplemental drink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Anna Arthur, PhD: lead
• Fresenius Kabi: collaborator

Related Publications (5)

• Chen X, Beilman B, Gibbs HD, Hamilton JL, Parker N, Bur AM, Caudell JJ, Gan GN, Hamilton-Reeves JM, Jim HSL, Kirtane K, Lominska C, Crowder SL, Arthur AE. Nutrition in head and neck cancer care: a roadmap and call for research. Lancet Oncol. 2025 Jun;26(6):e300-e310. doi: 10.1016/S1470-2045(25)00087-7.

  PMID: 40449504 BACKGROUND

• Morse RT, Ganju RG, Gan GN, Cao Y, Neupane P, Kakarala K, Shnayder Y, Lominska CE. Sarcopenia and Treatment Toxicity in Older Adults Undergoing Chemoradiation for Head and Neck Cancer: Identifying Factors to Predict Frailty. Cancers (Basel). 2022 Apr 22;14(9):2094. doi: 10.3390/cancers14092094.

  PMID: 35565223 BACKGROUND

• Maino Vieytes CA, Mondul AM, Crowder SL, Zarins KR, Edwards CG, Davis EC, Wolf GT, Rozek LS, Arthur AE, On Behalf Of The University Of Michigan Head And Neck Spore Program. Pretreatment Adherence to a Priori-Defined Dietary Patterns Is Associated with Decreased Nutrition Impact Symptom Burden in Head and Neck Cancer Survivors. Nutrients. 2021 Sep 9;13(9):3149. doi: 10.3390/nu13093149.

  PMID: 34579024 BACKGROUND

• Taha HM, Rozek LS, Chen X, Li Z, Zarins KR, Slade AN, Wolf GT, Arthur AE. Risk of Disease Recurrence and Mortality Varies by Type of Fat Consumed before Cancer Treatment in a Longitudinal Cohort of Head and Neck Squamous Cell Carcinoma Patients. J Nutr. 2022 May 5;152(5):1298-1305. doi: 10.1093/jn/nxac032.

  PMID: 35170737 BACKGROUND

• Crowder SL, Douglas KG, Yanina Pepino M, Sarma KP, Arthur AE. Nutrition impact symptoms and associated outcomes in post-chemoradiotherapy head and neck cancer survivors: a systematic review. J Cancer Surviv. 2018 Aug;12(4):479-494. doi: 10.1007/s11764-018-0687-7. Epub 2018 Mar 20.

  PMID: 29556926 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Sarcopenia; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Anna Arthur, PhD

CONTACT

913-945-7079; aarthur4@kumc.edu

Gregory Gan, PhD, MD

CONTACT

913-588-3431; ggan@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share