NCT05061316Completed
The Gut Microbiome As an Indicator of Readiness for Head & Neck Cancer Surgery
Source: ClinicalTrials.gov · Last updated 14 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 30 Aug 2021
- Start date
- 11 Mar 2022
- Primary completion date
- 31 Oct 2023
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Head and neck cancer
- NCT number
- NCT05061316
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 11 Mar 2022 to the primary completion date, 31 Oct 2023
- 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 (IBD, colon or rectal cancer, previous colon or small intestine resection)
- Chronic immunosuppression (i.e., transplant patients)
Other illness
- Allergy to fish oil or fish
- Autoimmune disorders requiring medication
- Stage III or higher Chronic Kidney Disease (CKD)
Age
- Age less than 18 years
Other
- Inability to speak and comprehend English
- Inability to consent for themselves
- Pregnancy
- Leukemia
- Cirrhosis
- Pancreatitis
Who the study is looking for
- 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
Age in the registry: 18 years to - · 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 |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.