An interventional study of Impact Advanced Recovery (Impact AR) and Boost® High Protein + Beneprotein® in Head & Neck Cancer, sponsored by University of Colorado, Denver. Not yet recruiting at 1 site in United States. Open to participants aged 40 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
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. The investigators 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.
The 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.
The primary goal of this study is to determine feasibility and safety.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 20 is below the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meets at least one of the following criteria for cancer cachexia, in addition to presence of systemic inflammation (CRP >5mg/L):
Presence of sarcopenia** on day of evaluation and > 2% weight loss* in the last six months
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Impact Advanced Recovery (Impact AR)
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.
Dietary Supplement: Boost® High Protein + Beneprotein®
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.
Calorie- and protein-matched nutritional supplement consisting of Boost® High Protein (8 fl oz) mixed with one scoop (6 g) of Beneprotein®.
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).
Time frame: 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.
Time frame: 24 months
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
Time frame: 24 months
Evaluate the impact of preoperative nutritional support on preservation of muscle quality and function in HNCC patients after primary cancer treatment
Preservation of muscle mass (SMI) on CT imaging from baseline (Day 0) to final assessment (post-RT Day 180) between control and experimental groups. Preservation of muscle quality (intramuscular adipose tissue (IMAT)) on CT imaging from baseline (Day 0) to final assessment (post-RT Day 180) between control and experimental groups.
Time frame: 60 months
Determine if liver function is altered after preoperative nutritional intervention
Change in overall plasma bile acid concentration (from research blood sample) from baseline (Day 0) to surgery between control and experimental groups. Change in primary: secondary bile acid ratio from baseline to surgery between control and experimental groups.
Time frame: 60 months
Start is estimated for Dec 2026; primary completion for Dec 2028, 24 months later.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 24 months is below that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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