Special Pre-Surgery Diet for Head and Neck Cancer

CM
Overseen ByCarissa M. Thomas, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special pre-surgery diet can improve recovery for individuals undergoing major head and neck cancer surgery. Participants will consume a nutritional drink called Nestlé Impact Advanced Recovery twice daily for five days before their surgery. The researchers seek to understand whether this diet alters the gut microbiome (the community of microbes in the digestive system) and leads to better post-surgery outcomes. The trial is recruiting adults diagnosed with head and neck cancer who are undergoing major surgery and have moderate or severe malnutrition.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery for future patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you have an autoimmune disorder requiring medication or are on chronic immunosuppression, you may not be eligible to participate.

What prior data suggests that this nutritional intervention is safe for pre-surgery patients with head and neck cancer?

Research has shown that Nestlé Impact Advanced Recovery supports the immune system, particularly after major surgery. Studies have found that this nutritional drink can reduce the risk of complications like fistulas (abnormal connections) and help patients leave the hospital sooner compared to standard care.

Previous patients have generally tolerated the drink well, with no major safety issues reported. The current study aims to assess how this pre-surgery nutrition might benefit head and neck cancer patients by potentially improving their surgical outcomes.

Participants in other studies have used the drink for similar durations without significant problems, suggesting it is safe for short-term use before surgery.12345

Why are researchers excited about this trial?

Nestlé Impact Advanced Recovery is unique because it focuses on boosting the immune system before surgery for head and neck cancer. Unlike standard nutritional approaches that might not target immune health specifically, this treatment is packed with immunonutrients like arginine, omega-3 fatty acids, and nucleotides. Researchers are excited about this blend because it could potentially enhance recovery and reduce complications by strengthening the body's defenses just days before surgery.

What evidence suggests that this nutritional intervention is effective for head and neck cancer surgery?

Research has shown that the Nestlé Impact Advanced Recovery supplement, provided to participants in this trial, can aid individuals undergoing surgery for head and neck cancer. Studies have found that it lowers the risk of complications such as postoperative fistulas, which are unusual connections between body parts, and reduces hospital stays compared to standard care. This supplement is rich in nutrients that support the immune system, helping the body manage cancer treatments more effectively. Previous research also found that it lessens severe side effects in these patients. Overall, these findings suggest that using this nutritional supplement before surgery may enhance recovery.35678

Who Is on the Research Team?

CM

Carissa M. Thomas, MD, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.
See 3 more

Exclusion Criteria

You are allergic to fish or fish oil.
Chronic immunosuppression (i.e., transplant patients)
I have been diagnosed with cirrhosis.
See 9 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Nutrition intervention groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

The impact of immunonutrition in head and neck cancer ...Immunonutrition significantly reduced postoperative fistulas and shortened hospital stays compared to standard care.
Nutritional Optimization for Head and Neck CancerNestle IMPACT AR is unique because it is an oral nutritional supplement specifically enriched with immunonutrients, which may help improve treatment tolerance ...
A double-blind phase III trial of immunomodulating ...In a previous phase II study an immunonutrient supplement was found to reduce severe acute toxicities for head and neck squamous cell cancer (HNSCC) ...
IMPACT Clinical Study Reference - Nestle Health ScienceA systematic review looking at the positive effects of immunonutrition in head and neck cancer patients undergoing cancer treatment in improving ...
Nestle Impact Advanced Recovery in Improving Surgery ...Assess the effect of perioperative use of Nestle Impact Advanced Recovery (AR) on the rate of post-operative wound complications within 30 days after major head ...
IMPACT Advanced Recovery® DrinkIMPACT Advanced Recovery specially formulated to support the immune system after major surgery. Proven to help promote better outcomes in patients.
Nestlé Health Science Impact Advanced Recovery® ...Impact Advanced Recovery Drink is a unique beverage specially formulated to support the body's immune system after major surgery.
Perioperative Nutritional Optimization in Head and Neck ...Patient must be willing to receive Nestle IMPACT Advance Recovery for five days prior to planned surgery as well as for 5 days after surgery. Ability to ...
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