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Head &Amp;Amp; Neck Squamous Cell CarcinomaPhase 1/2FORCENCT07180576

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

A Phase 1/2 study testing Nutrition counseling and Fresubin Supportan in people with Head &Amp;Amp; Neck Squamous Cell Carcinoma, run by Anna Arthur, PhD.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nutrition counseling and Fresubin Supportan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
1 Jun 2027to 31 Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Anna Arthur, PhD contact

913-945-7079

aarthur4@kumc.edu

Gregory Gan, PhD, MD contact

913-588-3431

ggan@kumc.edu

About this study

Official title: The FORCE Trial Pilot

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.

Read the 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.

Being tested
Nutrition counseling, Fresubin Supportan
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
Medical subject headings
Head and Neck Neoplasms, Sarcopenia, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutrition counselingBehavioural

    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.

  • Fresubin SupportanDrug

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

Study groups in NCT07180576
Study groupRoleWhat they receive
Supplemental drinkExperimentalThis is a single-arm design; comparisons are pre- vs. post-intervention or against feasibility thres
Receives: Behavioral: Nutrition counseling; Drug: Fresubin Supportan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment rate

    Calculated as the number of participants enrolled per month during the active recruitment period. Presented descriptively

    Measured: Through study completion, approximately 18 months

  2. 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.

    Measured: From baseline (Week -2) to 3 months post-chemoradiotherapy

  3. 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.

    Measured: From baseline (Week -2) to 3 months post-chemoradiotherapy

  4. 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).

    Measured: From baseline (Week -2) to 3 months post-chemoradiotherapy

  5. Supplement Acceptability

    Assessed via structured questions during RDN visits and a final survey completed by the adult participant/caregiver.

    Measured: From baseline (Week -2) to 3 months post-chemoradiotherapy

  6. 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%.

    Measured: From baseline (Week -2) through 3 months post-chemoradiotherapy

Secondary outcomes (4)

  1. Body composition

    Skeletal Muscle Index as assessed using diagnostic CT images with sliceomatic software.

    Measured: From baseline (Week -2) to 3 months post-chemoradiotherapy

  2. Nutrition Impact Symptoms

    Change in patient-reported NIS will be assessed using the MDASI-HN total symptom severity score and relevant subscale scores.

    Measured: From baseline (Week -2) to 3 months post-chemoradiotherapy

  3. Red Blood Cell Fatty Acid Profiles

    Changes in key red blood cell (RBC) fatty acid levels (EPA, DHA, Arachidonic Acid, EPA:AA ratio)

    Measured: From baseline (Week -2) to 3 months post-chemoradiotherapy

  4. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2025
  2. Study start1 Jun 2027 (estimated)
  3. Primary completion31 May 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07180576
Sponsor's protocol ID
00161711
Other IDs
UKHSRR number: 4907
Acronym
FORCE
Status last verified
Aug 2026
First submitted
5 Sep 2025
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 29556926

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nutrition counseling and Fresubin Supportan in people with Head &Amp;Amp; Neck Squamous Cell Carcinoma, run by Anna Arthur, PhD.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Arthur, PhD (913-945-7079, aarthur4@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment rate (time frame: Through study completion, approximately 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07180576, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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