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

Официальное название

The FORCE Trial Pilot

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Recruitment rate [Срок оценки: Through study completion, approximately 18 months]
• Adherence Rate [Срок оценки: From baseline (Week -2) to 3 months post-chemoradiotherapy]
• Retention Rate [Срок оценки: From baseline (Week -2) to 3 months post-chemoradiotherapy]
• Adverse Events [Срок оценки: From baseline (Week -2) to 3 months post-chemoradiotherapy]
• Supplement Acceptability [Срок оценки: From baseline (Week -2) to 3 months post-chemoradiotherapy]
• Supplement Discontinuation due to AEs [Срок оценки: From baseline (Week -2) through 3 months post-chemoradiotherapy]

Вторичные конечные точки (4)

• Body composition [Срок оценки: From baseline (Week -2) to 3 months post-chemoradiotherapy]
• Nutrition Impact Symptoms [Срок оценки: From baseline (Week -2) to 3 months post-chemoradiotherapy]
• Red Blood Cell Fatty Acid Profiles [Срок оценки: From baseline (Week -2) to 3 months post-chemoradiotherapy]
• FADS1/2 Genotyping [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07180576 · 00161711 · UKHSRR number: 4907

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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