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| ID | Type | Description | Link |
|---|---|---|---|
| UKHSRR number: 4907 | Other Identifier | University of Kansas Medical Center |
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| Name | Class |
|---|---|
| Fresenius Kabi | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplemental drink | Experimental | This is a single-arm design; comparisons are pre- vs. post-intervention or against feasibility thres |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. |
| Measure | Description | Time Frame |
|---|---|---|
| Body composition | Skeletal Muscle Index as assessed using diagnostic CT images with sliceomatic software. | From baseline (Week -2) to 3 months post-chemoradiotherapy |
| Nutrition Impact Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Arthur, PhD | Contact | 913-945-7079 | aarthur4@kumc.edu | |
| Gregory Gan, PhD, MD | Contact | 913-588-3431 | ggan@kumc.edu |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40449504 | Result | 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. | |
| 35565223 | Result |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D055948 | Sarcopenia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| Fresubin Supportan | Drug | Two bottles per day of Fresubin Supportan, a fish oil-enriched high calorie, high protein oral nutrition supplement. |
|
| From baseline (Week -2) through 3 months post-chemoradiotherapy |
Change in patient-reported NIS will be assessed using the MDASI-HN total symptom severity score and relevant subscale scores.
| From baseline (Week -2) to 3 months post-chemoradiotherapy |
| Red Blood Cell Fatty Acid Profiles | Changes in key red blood cell (RBC) fatty acid levels (EPA, DHA, Arachidonic Acid, EPA:AA ratio) | From baseline (Week -2) to 3 months post-chemoradiotherapy |
| FADS1/2 Genotyping | 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. | Baseline |
| 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. |
| 34579024 | Result | 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. |
| 35170737 | Result | 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. |
| 29556926 | Result | 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. |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |