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
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Kristi Engle Folchert
- Telefonnummer: 303-724-9528
- E-Mail: Kristi.EngleFolchert@cuanschutz.edu
Studienorte
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80045
- UCHealth University of Colorado Hospital
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Kontakt:
- Kristi Engle Folchert
- Telefonnummer: 303-724-9528
- E-Mail: Kristi.EngleFolchert@cuanschutz.edu
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Hauptermittler:
- Carissa Thomas, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
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Provision to sign and date the consent form.
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Stated willingness to comply with all study procedures and be available for the duration of the study.
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Willingness to adhere to the intervention regimen, including enrollment at least 15 days before scheduled surgery.
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Be a male or female aged 40-89 years.
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For persons of reproductive potential, agree to use of highly effective method(s) of contraception and negative pregnancy test, if applicable.
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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.
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Meets at least one of the following criteria for cancer cachexia, in addition to presence of systemic inflammation (CRP >5mg/L):
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> 5% weight loss* in the last six months or
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BMI < 20 kg/m2 on day of evaluation and > 2% weight loss* in the last six months or
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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.
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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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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. |
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. |
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Aktiver Komparator: Active Comparator Arm
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. |
Calorie- and protein-matched nutritional supplement consisting of Boost® High Protein (8 fl oz) mixed with one scoop (6 g) of Beneprotein®. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Study feasibility of nutritional interventions before head and neck cancer surgery.
Zeitfenster: 24 months
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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). |
24 months
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Study safety of nutritional interventions before head and neck cancer surgery.
Zeitfenster: 24 months
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Safety and Tolerability: Incidence of adverse events related to nutritional supplement (e.g., refeeding syndrome). Rate of discontinuation due to intolerance or adverse events. |
24 months
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Evaluate the impact of preoperative nutritional support on preservation of muscle quality and function in HNCC patients after primary cancer treatment
Zeitfenster: 24 months
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Preservation of hand grip strength from baseline (Day 0) to final assessment (post-RT Day 180) between control and experimental groups |
24 months
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Evaluate the impact of preoperative nutritional support on preservation of muscle quality and function in HNCC patients after primary cancer treatment
Zeitfenster: 60 months
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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. |
60 months
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Determine if liver function is altered after preoperative nutritional intervention
Zeitfenster: 60 months
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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. |
60 months
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Carissa M Thomas, MD PhD, UCHealth University of Colorado Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 25-1893.cc
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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