Clinical trial · Interventional
The FORCE Trial Pilot: Fish Oil-enriched Nutrition for Radiotherapy in Cancer of the hEad and Neck
The FORCE Trial Pilot
NCT07180576CI-TRIAL-00121104FORCEnot yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head &Amp;Amp; Neck Squamous Cell Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fresubin Supportan | Drug | — | UNRESOLVED |
| Nutrition counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supplemental drink
- description
- This is a single-arm design; comparisons are pre- vs. post-intervention or against feasibility thres
- interventionNames
- Behavioral: Nutrition counseling
- Drug: Fresubin Supportan
Primary outcomes (6)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (5)
- RESULTChen 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
- RESULTMorse 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
- RESULTMaino 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
- RESULTTaha 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
- RESULTCrowder 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