NCT07911150Not yet recruiting
Gut-Liver-Muscle Axis in Cancer Cachexia
The Gut-Liver-Muscle Axis in Patients With Head and Neck Cancer Who Experience Weight Loss: Influence of Preoperative Nutritional Supplementation
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 1 Dec 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Head and neck cancer
- NCT number
- NCT07911150
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 1 Dec 2026 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Gastrointestinal disorders (inflammatory bowel disease, colon or rectal cancer, previous colon or small intestine resection).
Other illness
- 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.
- 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).
- Type 1 or Type 2 Diabetes not managed with insulin.
- History of chemoradiation (except preoperative immunotherapy) or patients with recurrent head and neck cancer.
Other
- Active acute or chronic pancreatitis.
Who the study is looking for
- 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):
- \> 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.
Age in the registry: 40 years to 89 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCHealth University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.