Clinical trial · Interventional
The Gut Microbiome As an Indicator of Readiness for Head & Neck Cancer Surgery
NCT05061316CI-TRIAL-00086034completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to understand how a pre-operative nutritional intervention alters the gut microbiome and improves outcomes after major head and neck cancer surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Head and Neck | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Nutrition Aspect of Cancer | Head and Neck Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nestlé Impact Advanced Recovery | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nutrition intervention group
- description
- Participants will receive Nestlé Impact Advanced Recovery Immunonutrition two times daily for 5 days leading up to the date of surgery. Nestlé Impact Advanced Recovery will be administered either orally or through a feeding tube.
- interventionNames
- Dietary Supplement: Nestlé Impact Advanced Recovery
Primary outcomes (1)
- measure
- Define changes in the gut microbiome in malnourished patients with head and neck cancer after a pre-operative nutrition intervention via analyses of stool samples.
- timeFrame
- Baseline - 6 months
- description
- Stool samples will be collected prior to the nutrition intervention and after completing 5 days of intervention. Stool samples will be processed and sequenced for 16S microbiome analysis. The composition of the gut microbiome will be compared before and after the immunonutrition intervention.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (age 18+) * Male or female * Diagnosis of head and neck cancer that will be treated with major surgery * Major surgeries included will be any free flap reconstruction, any regional flap reconstruction (including pec major, submental flap, and supraclavicular artery island flap), oral composite resection, oropharyngectomy, total laryngectomy, cutaneous malignancy if it includes a free flap or regional flap reconstruction, parotidectomy if it includes a free flap or regional flap reconstruction, maxillectomy with or without orbital exenteration, lateral temporal bone resection, and/or a radical neck dissection if it includes a free flap or regional flap reconstruction * Diagnosis of moderate (Stage B) or severe (Stage C) malnutrition, based on the patient-generated subjective global assessment (PG-SGA) * Ability to speak and comprehend English * Ability to consent for themselves Exclusion Criteria: * Age less than 18 years * Inability to speak and comprehend English * Inability to consent for themselves * Pregnancy * Allergy to fish oil or fish * Gastrointestinal disorders (IBD, colon or rectal cancer, previous colon or small intestine resection) * Autoimmune disorders requiring medication * Chronic immunosuppression (i.e., transplant patients) * Leukemia * Stage III or higher Chronic Kidney Disease (CKD) * Cirrhosis * Pancreatitis
References
Publications (0)
Data not yet available
No reference posted for this study.