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NOT YET RECRUITING

NCT07911150

Gut-Liver-Muscle Axis in Cancer Cachexia

Sponsor: University of Colorado, Denver

View on ClinicalTrials.gov

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. 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.

Official title: The Gut-Liver-Muscle Axis in Patients With Head and Neck Cancer Who Experience Weight Loss: Influence of Preoperative Nutritional Supplementation

Key Details

Gender

All

Age Range

40 Years - 89 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-12

Completion Date

2029-12

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Head & Neck Cancer

Interventions

DIETARY_SUPPLEMENT

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

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®.

Inclusion Criteria: * 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. * 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): 1. \> 5% weight loss\* in the last six months or 2. BMI \< 20 kg/m2 on day of evaluation and \> 2% weight loss\* in the last six months or 3. 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. Exclusion Criteria: * 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.

Locations (1)

UCHealth University of Colorado Hospital

Aurora, Colorado, United States