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Special Pre-Surgery Diet for Head and Neck Cancer

N/A

Waitlist Available

Led By Carissa M. Thomas, MD, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of moderate (Stage B) or severe (Stage C) malnutrition, based on the patient-generated subjective global assessment (PG-SGA)

Ability to consent for themselves

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline - 6 months

Awards & highlights

Study Summary

This trial will test whether a special diet before surgery can improve outcomes for people with head and neck cancer.

Who is the study for?

Adults diagnosed with head and neck cancer preparing for major surgery, who are moderately or severely malnourished. They must understand English and be able to consent. Excluded are those under 18, pregnant, with autoimmune disorders requiring medication, chronic immunosuppression, advanced kidney disease, cirrhosis, pancreatitis or allergies to fish oil.Check my eligibility

What is being tested?

The study is testing the effects of a nutritional drink called Nestlé Impact Advanced Recovery on the gut microbiome and surgical outcomes in patients undergoing major surgery for head & neck cancers.See study design

What are the potential side effects?

While not explicitly stated here, potential side effects may include digestive discomfort or allergic reactions related to ingredients in the nutritional drink such as fish oil.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with moderate to severe malnutrition.

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I can make my own medical decisions.

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I have had major surgery involving tissue reconstruction.

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I have head or neck cancer and will undergo major surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline - 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nutrition intervention groupExperimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,583 Previous Clinical Trials

2,280,024 Total Patients Enrolled

Carissa M. Thomas, MD, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Nestlé Impact Advanced Recovery Clinical Trial Eligibility Overview. Trial Name: NCT05061316 — N/A

Head and Neck Cancers Research Study Groups: Nutrition intervention group

Head and Neck Cancers Clinical Trial 2023: Nestlé Impact Advanced Recovery Highlights & Side Effects. Trial Name: NCT05061316 — N/A

Nestlé Impact Advanced Recovery 2023 Treatment Timeline for Medical Study. Trial Name: NCT05061316 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been included in this clinical experiment?

"Affirmative, the data accessible on clinicaltrials.gov asserts that this medical trial is presently enrolling participants. The study was posted on March 11th 2022 and amended most recently on March 17th 2022. There are 30 slots available at a single location."

Answered by AI

Are there any vacancies for this clinical experiment available at the moment?

"Affirmative. Clinicaltrials.gov's registry indicates that this experiment is currently enrolling participants, which began on March 11th 2022 and has since been revised as of the 17th of such month. A total of 30 patients need to be enlisted from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Gut Microbiome as an Indicator of Readiness for Head & Neck Cancer Surgery

Carissa M Thomas, MD PhD 2022. "The Gut Microbiome as an Indicator of Readiness for Head & Neck Cancer Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05061316.

All > Microbiome