Special Pre-Surgery Diet for Head and Neck Cancer

Overseen By Carissa M. Thomas, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Pregnancy, Gastrointestinal disorders, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Carissa M. Thomas, MD, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with moderate to severe malnutrition.

Ability to speak and comprehend English

I am either male or female.

Exclusion Criteria

You are allergic to fish or fish oil.

Chronic immunosuppression (i.e., transplant patients)

I have been diagnosed with cirrhosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Nutrition Intervention

Participants receive Nestlé Impact Advanced Recovery Immunonutrition two times daily for 5 days leading up to the date of surgery

5 days

Daily administration

Surgery and Immediate Post-operative Care

Participants undergo head and neck cancer surgery and receive immediate post-operative care

1-2 weeks

Follow-up

Participants are monitored for changes in the gut microbiome and post-operative outcomes

6 months

Regular follow-up visits

Treatment Details

Interventions

• Nestlé Impact Advanced Recovery

Trial Overview 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.

Participant Groups

Group I: Nutrition intervention group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+