Head &Amp;Amp; Neck Squamous Cell Carcinoma
Conditions
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
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
BEHAVIORALNutrition 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.
DRUGFresubin Supportan
Two bottles per day of Fresubin Supportan, a fish oil-enriched high calorie, high protein oral nutrition supplement.
Sponsors
Anna Arthur, PhD
Fresenius Kabi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | Through study completion, approximately 18 months | Calculated as the number of participants enrolled per month during the active recruitment period. Presented descriptively |
| Adherence Rate | 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 | 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 | 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 | 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 | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | From baseline (Week -2) to 3 months post-chemoradiotherapy | Skeletal Muscle Index as assessed using diagnostic CT images with sliceomatic software. |
| Nutrition Impact Symptoms | From baseline (Week -2) to 3 months post-chemoradiotherapy | Change in patient-reported NIS will be assessed using the MDASI-HN total symptom severity score and relevant subscale scores. |
| Red Blood Cell Fatty Acid Profiles | From baseline (Week -2) to 3 months post-chemoradiotherapy | Changes in key red blood cell (RBC) fatty acid levels (EPA, DHA, Arachidonic Acid, EPA:AA ratio) |
| FADS1/2 Genotyping | Baseline | FADS1/2 Genotyping: Genotype frequencies (I/I, I/D, D/D for rs66698963) and allele frequencies (I allele, D allele) will be calculated and reported descriptively for the baseline samples. Exploratory analyses may examine outcomes stratified by genotype, but these will be hypothesis-generating only due to the small N. |
Contacts
CONTACTAnna Arthur, PhD
CONTACTGregory Gan, PhD, MD
Outcome results
None listed