The FORCE Trial Pilot
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed with Stage I - IV oral cavity, hypopharyngeal, oropharyngeal, or laryngeal cancer
- •Planned for definitive radiotherapy with or without surgery and chemotherapy
排除标准
- •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)
研究组 & 干预措施
Supplemental drink
This is a single-arm design; comparisons are pre- vs. post-intervention or against feasibility thres
干预措施: Nutrition counseling (Behavioral)
Supplemental drink
This is a single-arm design; comparisons are pre- vs. post-intervention or against feasibility thres
干预措施: Fresubin Supportan (Drug)
结局指标
主要结局
Recruitment rate
时间窗: Through study completion, approximately 18 months
Calculated as the number of participants enrolled per month during the active recruitment period. Presented descriptively
Adherence Rate
时间窗: 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.
Retention Rate
时间窗: 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.
Adverse Events
时间窗: 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).
Supplement Acceptability
时间窗: 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.
Supplement Discontinuation due to AEs
时间窗: 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%.
Recruitment rate
时间窗: Through study completion, approximately 18 months
Calculated as the number of participants enrolled per month during the active recruitment period. Presented descriptively
Adherence Rate
时间窗: 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.
Retention Rate
时间窗: 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.
Adverse Events
时间窗: 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).
Supplement Acceptability
时间窗: 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.
Supplement Discontinuation due to AEs
时间窗: 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%.
次要结局
- Body composition(From baseline (Week -2) to 3 months post-chemoradiotherapy)
- FADS1/2 Genotyping(Baseline)
- 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)
研究者
Anna Arthur, PhD
Associate Professor
University of Kansas Medical Center