Head & Neck CancerNCT07911150
Gut-Liver-Muscle Axis in Cancer Cachexia
A study testing Impact Advanced Recovery (Impact AR) and Boost® High Protein + Beneprotein® in people with Head & Neck Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to determine if consuming a nutritional supplement before surgery affects weight loss, inflammation, and muscle in people with head and neck cancer cachexia. Read more about this study
- Who is it for?
- Ages 40 to 89 years
- Conditions the study is for
- Head & Neck Cancer
- What is being tested?
- Impact Advanced Recovery (Impact AR) and Boost® High Protein + Beneprotein®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2029
- Phase
- Interventional
- 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 40 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Willingness to adhere to the intervention regimen, including enrollment at least 15 days before scheduled surgery.
- Be a male or female aged 40-89 years.
- For persons of reproductive potential, agree to use of highly effective method(s) of contraception and negative pregnancy test, if applicable.
- Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection.
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- Planned standard of care surgery with curative intent for squamous cell carcinoma. Only major surgery will be included with major surgery defined as any free flap reconstruction, any regional flap reconstruction (including pec major, submental flap, and supraclavicular artery island flap), oral composite resection, oropharyngectomy, total laryngectomy, maxillectomy with or without orbital exenteration, and/or a radical neck dissection if it includes a free flap or regional flap reconstruction.
- Meets at least one of the following criteria for cancer cachexia, in addition to presence of systemic inflammation (CRP >5mg/L):
- > 5% weight loss* in the last six months or
- BMI < 20 kg/m2 on day of evaluation and > 2% weight loss* in the last six months or
- Presence of sarcopenia** on day of evaluation and > 2% weight loss* in the last six months
- Percentage weight loss calculated as: (current weight - previous weight)/previous weight × 100; may be documented or reported ** Sarcopenia defined by accepted skeletal muscle index for age and sex based on L3 CT body composition analysis or alternatively by physical exam by a clinician.
Who cannot join
- Contraindication to consumption of Impact AR, such as pregnancy, organ transplantation, autoimmune disease, chronic immunosuppression, severe allergy to fish oil, or strict adherence to vegetarian/vegan diet, or other contraindications at the discretion of investigator.
- Gastrointestinal disorders (inflammatory bowel disease, colon or rectal cancer, previous colon or small intestine resection).
- Stage III or higher chronic kidney disease.
- History of inflammatory liver disorders including (Cirrhosis, chronic hepatitis B or C infection, primary biliary disease, acute or chronic pancreatitis).
- Active acute or chronic pancreatitis.
- Type 1 or Type 2 Diabetes not managed with insulin.
- History of chemoradiation (except preoperative immunotherapy) or patients with recurrent head and neck cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045
Kristi Engle Folchert, 303-724-9528, Kristi.EngleFolchert@cuanschutz.edu
Carissa Thomas, MD
About this study
Official title: The Gut-Liver-Muscle Axis in Patients With Head and Neck Cancer Who Experience Weight Loss: Influence of Preoperative Nutritional Supplementation
The purpose of this study is to determine if consuming a nutritional supplement before surgery affects weight loss, inflammation, and muscle in people with head and neck cancer cachexia. We are doing this study to learn more about weight and muscle loss in people with cancer that does not improve with just eating more calories; this condition is called cancer cachexia. Nutritional drinks created with nutrients that may reduce inflammation and help balance the body's immune system may be a promising treatment for cancer cachexia.
Our primary question is if these nutritional interventions affect muscle function through the gut-liver-muscle axis, which can be thought of as a biological "three-way conversation." The gut digests food and hosts a microbiome (a community of bacteria), the liver processes these nutrients and filters toxins, and muscles use this energy. If one part struggles, it can affect the others, impacting overall energy, metabolism, and strength.
Our primary goal of this study is to determine feasibility and safety.
- Conditions
- Head & Neck Cancer
- Being tested
- Impact Advanced Recovery (Impact AR), Boost® High Protein + Beneprotein®
- Keywords
- weight loss, systemic inflammation
- Medical subject headings
- Head and Neck Neoplasms, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact Advanced Recovery (Impact AR)Dietary supplement
Impact Advanced Recovery® (Impact AR), a commercially available immunonutrition supplement. The supplement contains protein, L-arginine, and omega-3 fatty acids and is designed to provide nutritional support and modulate inflammation. Participants may consume the supplement orally or through a feeding tube.
Boost® High Protein + Beneprotein®Dietary supplement
Calorie- and protein-matched nutritional supplement consisting of Boost® High Protein (8 fl oz) mixed with one scoop (6 g) of Beneprotein®.
| Study group | Role | What they receive |
|---|---|---|
| Impact AR | Experimental | Participants will consume one 8.45 fl oz carton of Impact Advanced Recovery® twice daily for 15 days before surgery. The supplement contains protein, L-arginine, and omega-3 fatty acids and is administered orally or through a feeding tube. Receives: Dietary Supplement: Impact Advanced Recovery (Impact AR) |
| Active Comparator Arm | Active comparator | Participants will consume one 8 fl oz carton of Boost® High Protein mixed with one scoop (6 g) of Beneprotein® twice daily for 15 days before surgery. The supplement is calorie- and protein-matched to the experimental intervention and may be administered orally or through a feeding tube. Receives: Dietary Supplement: Boost® High Protein + Beneprotein® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study feasibility of nutritional interventions before head and neck cancer surgery.
Recruitment (50% consented): Percentage of eligible patients enrolled within the planned timeframe (based on projected monthly accrual). Adherence (80% of participants): Proportion of participants consuming ≥50% of prescribed Impact AR or Control Drink doses over 15 days. Specimen Collection (70% of participants): Percentage of participants providing all specimens (excluding optional stool specimens). Completion (70% of participants): Percentage of participants with complete handgrip strength measurements at all time points (baseline, post-op, post-RT).
Measured: 24 months
Study safety of nutritional interventions before head and neck cancer surgery.
Safety and Tolerability: Incidence of adverse events related to nutritional supplement (e.g., refeeding syndrome). Rate of discontinuation due to intolerance or adverse events.
Measured: 24 months
Secondary outcomes (1)
Evaluate the impact of preoperative nutritional support on preservation of muscle quality and function in HNCC patients after primary cancer treatment
Preservation of hand grip strength from baseline (Day 0) to final assessment (post-RT Day 180) between control and experimental groups
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head & Neck CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carissa M Thomas, MD PhD, Principal investigator, UCHealth University of Colorado Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911150
- Sponsor's protocol ID
- 25-1893.cc
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gut-Liver-Muscle Axis in Patients With Head and Neck Cancer Who Experience Weight Loss: Influence of Preoperative Nutritional Supplementation
- ClinicalTrials.gov ID
- NCT07911150
- Acronym / sponsor ID
- 25-1893.cc
- Conditions
- Head & Neck Cancer
- Keywords
- weight loss, systemic inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if consuming a nutritional supplement before surgery affects weight loss, inflammation, and muscle in people with head and neck cancer cachexia. We are doing this study to learn more about weight and muscle loss in people with cancer that does not improve with just eating more calories; this condition is called cancer cachexia. Nutritional drinks created with nutrients that may reduce inflammation and help balance the body's immune system may be a promising treatment for cancer cachexia.
Our primary question is if these nutritional interventions affect muscle function through the gut-liver-muscle axis, which can be thought of as a biological "three-way conversation." The gut digests food and hosts a microbiome (a community of bacteria), the liver processes these nutrients and filters toxins, and muscles use this energy. If one part struggles, it can affect the others, impacting overall energy, metabolism, and strength.
Our primary goal of this study is to determine feasibility and safety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impact AR | Experimental | Dietary Supplement: Impact Advanced Recovery (Impact AR)Participants will consume one 8.45 fl oz carton of Impact Advanced Recovery® twice daily for 15 days before surgery. The supplement contains protein, L-arginine, and omega-3 fatty acids and is administered orally or through a feeding tube. |
| Active Comparator Arm | Active comparator | Dietary Supplement: Boost® High Protein + Beneprotein®Participants will consume one 8 fl oz carton of Boost® High Protein mixed with one scoop (6 g) of Beneprotein® twice daily for 15 days before surgery. The supplement is calorie- and protein-matched to the experimental intervention and may be administered orally or through a feeding tube. |
Who may qualify
- Ages
- 40 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Willingness to adhere to the intervention regimen, including enrollment at least 15 days before scheduled surgery.
- Be a male or female aged 40-89 years.
- For persons of reproductive potential, agree to use of highly effective method(s) of contraception and negative pregnancy test, if applicable.
Key exclusion criteria (7 listed)
- Contraindication to consumption of Impact AR, such as pregnancy, organ transplantation, autoimmune disease, chronic immunosuppression, severe allergy to fish oil, or strict adherence to vegetarian/vegan diet, or other contraindications at the discretion of investigator.
- Gastrointestinal disorders (inflammatory bowel disease, colon or rectal cancer, previous colon or small intestine resection).
- Stage III or higher chronic kidney disease.
- History of inflammatory liver disorders including (Cirrhosis, chronic hepatitis B or C infection, primary biliary disease, acute or chronic pancreatitis).
- Active acute or chronic pancreatitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact Advanced Recovery (Impact AR)Impact Advanced Recovery® (Impact AR), a commercially available immunonutrition supplement. The supplement contains protein, L-arginine, and omega-3 fatty acids and is designed to provide nutritional support and modulate inflammation. Participants may consume the supplement orally or through a feeding tube. | Dietary supplement | Impact AR |
| Boost® High Protein + Beneprotein®Calorie- and protein-matched nutritional supplement consisting of Boost® High Protein (8 fl oz) mixed with one scoop (6 g) of Beneprotein®. | Dietary supplement | Active Comparator Arm |
Primary outcome
Study feasibility of nutritional interventions before head and neck cancer surgery.
Time frame: 24 months
Recruitment (50% consented): Percentage of eligible patients enrolled within the planned timeframe (based on projected monthly accrual). Adherence (80% of participants): Proportion of participants consuming ≥50% of prescribed Impact AR or Control Drink doses over 15 days. Specimen Collection (70% of participants): Percentage of participants providing all specimens (excluding optional stool specimens). Completion (70% of participants): Percentage of participants with complete handgrip strength measurements at all time points (baseline, post-op, post-RT).
Study safety of nutritional interventions before head and neck cancer surgery.
Time frame: 24 months
Safety and Tolerability: Incidence of adverse events related to nutritional supplement (e.g., refeeding syndrome). Rate of discontinuation due to intolerance or adverse events.
1 secondary outcome
Evaluate the impact of preoperative nutritional support on preservation of muscle quality and function in HNCC patients after primary cancer treatment
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carissa M Thomas, MD PhD principal investigator
UCHealth University of Colorado Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact Advanced Recovery (Impact AR) and Boost® High Protein + Beneprotein® in people with Head & Neck Cancer, run by University of Colorado, Denver at 1 site in United States.
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 12 inclusion and 7 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Kristi Engle Folchert (303-724-9528, Kristi.EngleFolchert@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study feasibility of nutritional interventions before head and neck cancer surgery. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026; AzTrials last refreshed its copy on 3 Nov 2026.