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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

Must not have

Cirrhosis

Stage III or higher Chronic Kidney Disease (CKD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline - 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with cirrhosis.

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My kidney disease is at stage III or more advanced.

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I cannot give consent for medical procedures by myself.

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I am on medication for an autoimmune disorder.

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I have pancreatitis.

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I have leukemia.

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I am under 18 years old.

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I have a history of gastrointestinal disorders or surgeries.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met