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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Kristi Engle Folchert
- Numero di telefono: 303-724-9528
- Email: Kristi.EngleFolchert@cuanschutz.edu
Luoghi di studio
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Colorado
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Aurora, Colorado, Stati Uniti, 80045
- UCHealth University of Colorado Hospital
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Contatto:
- Kristi Engle Folchert
- Numero di telefono: 303-724-9528
- Email: Kristi.EngleFolchert@cuanschutz.edu
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Investigatore principale:
- Carissa Thomas, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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®. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Study feasibility of nutritional interventions before head and neck cancer surgery.
Lasso di tempo: 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.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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
Lasso di tempo: 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
Lasso di tempo: 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
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Carissa M Thomas, MD PhD, UCHealth University of Colorado Cancer Center
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Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 25-1893.cc
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