Nutritional Optimization for Head and Neck Cancer

Overseen By Ginevra Ciavarella

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Must not be taking: Immuno-nutrition, Anabolic steroids

Disqualifiers: Distant metastases, Galactosemia, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special nutritional drink, Nestle IMPACT Advanced Recovery, can reduce wound complications after major surgery for head and neck cancer patients. Participants will consume the drink before and after surgery to determine if it improves recovery compared to standard nutritional care. Individuals diagnosed with head and neck cancer and planning to undergo major surgery, such as a total laryngectomy or large oral cavity surgery, might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance recovery for future patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking certain nutritional supplements or anabolic steroids. Other dietary supplements and corticosteroids are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Nestle IMPACT Advanced Recovery (AR) has been used in numerous studies with thousands of patients. This nutritional drink is designed to support the immune system, particularly after major surgery. Studies indicate it can lead to better outcomes for patients.

The formula contains special nutrients that may help patients handle treatment more effectively. This is especially important for those undergoing surgery for head and neck cancer. Malnutrition, or inadequate nutrition, is common in these cases and can lead to complications after surgery. Nestle IMPACT AR aims to address this issue.

Although specific details on side effects are not provided, the product has undergone extensive testing and is generally well-tolerated. This suggests it is safe and could be a suitable option for those considering participation in a clinical trial involving this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Nestle IMPACT AR for head and neck cancer patients because it's designed to support nutrition specifically around the time of surgery. Unlike standard enteral tube feeds, which provide general nutritional support, Nestle IMPACT AR is rich in specific nutrients like arginine, omega-3 fatty acids, and nucleotides. These ingredients are thought to enhance immune function and help the body recover more effectively from surgery. By focusing on these targeted nutrients, Nestle IMPACT AR aims to optimize recovery and improve outcomes for patients undergoing surgery for head and neck cancer.

What evidence suggests that Nestle IMPACT AR is effective for reducing wound complications in head and neck cancer surgery?

Research has shown that Nestle IMPACT AR, a drink with added nutrients to boost the immune system, may aid recovery after surgery for head and neck cancer. In this trial, participants will receive Nestle IMPACT AR either orally or via tube feeding, depending on their post-operative eating ability. Studies have found that this type of nutrition can significantly lower the risk of post-surgery complications, such as fistulas (abnormal connections between organs) and wound infections, compared to regular care. It has also reduced the length of hospital stays. These benefits likely stem from its unique formula that supports the immune system after major surgeries. Overall, early findings suggest that Nestle IMPACT AR may improve surgical outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Barry Wenig, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

Adults over 18 with head and neck cancer who are about to have major surgery that requires a hospital stay of at least four days. They must have recent body imaging results, be willing to take Nestle IMPACT Advanced Recovery before and after surgery, and agree to sign the consent form.

Inclusion Criteria

I have had a PET-CT scan or similar within the last 4 weeks.

Ability to understand and the willingness to sign a written informed consent document

I have head or neck cancer and can undergo surgery.

Exclusion Criteria

I have cancer that has spread to distant parts of my body or I have more than one type of cancer.

Psychiatric illness/social situations that would limit compliance with study requirements.

I cannot eat or receive nutrition by mouth or feeding tube.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Nutritional Optimization

Participants receive nutritional supplementation with Nestle Impact AR for 5 days before surgery

1 week

1 visit (in-person)

Post-operative Nutritional Support

Participants receive Nestle Impact AR or standard enteral tube feeds for 5 days post-surgery

1 week

In-patient care

Follow-up

Participants are monitored for post-operative wound complications and tissue flap loss

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nestle IMPACT AR

Trial Overview The trial is testing if special nutritional drinks (Nestle IMPACT AR) given before and after major head and neck surgery can reduce wound complications compared to standard tube feeds.

How Is the Trial Designed?

Group I: Standard enteral tube feeds Experimental Treatment 1 Intervention

Patients will be instructed to continue a normal diet before surgery. Post-operatively, patients will receive standard of care isocaloric and iso-nitrogenous standard enteral tube feeds

Group II: Nestle IMPACT AR Experimental Treatment 1 Intervention

Patients will be encouraged to continue their regular diet until their surgery day. In addition, beginning 5 days before surgery, subjects will be instructed to drink three, 6 ounce cartons of Nestle IMPACT AR each day until their surgery. Post operatively patients who are able to eat orally, will be given three, 6 ounce cartons of Nestle IMPACT AR to drink each day for 5 days. Patients who are not able to tolerate an oral diet will be given Nestle IMPACT via a continuous tube feeding for 5 days through a temporary nasogastric feeding tube placed per standard post-operative care. Dosing of the tube feeding will be based on weight at a rate of approximately 70-75 cc/hour.

Nestle IMPACT AR is already approved in United States, European Union for the following indications:

Approved in United States as Nestle Impact Advanced Recovery for:

• Nutritional supplement for patients pre- and post major-elective surgery, after severe trauma/injury, or with pressure ulcers and other chronic wounds

Approved in European Union as Nestle Impact Advanced Recovery for:

• Pre-operative preparation and post-operative recovery from major elective surgery: Gastrointestinal cancer (esophageal, gastric, pancreatic, colonic), Bladder cancer, Gynecological cancer, Head and neck cancer, Non-small cell lung cancer, Cardiac, Hernia and Orthopedic

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Published Research Related to This Trial

In a study of 17 patients with oropharyngeal and hypopharyngeal cancer undergoing chemoradiotherapy, the nutritional supplement Prosure®, rich in omega-3 fatty acids, significantly reduced body weight loss compared to a historical control group (7.3% vs 10.3%, p<0.01).

Prosure® also led to a significant reduction in the incidence of severe oral mucositis (Grade 3-4) among patients, with rates of 24% in the Prosure® group compared to 58% in the control group (p<0.05).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Nutritional Supplement with a High Blend Ratio of ω-3 Fatty Acids(Prosure®) Reduces Severe Oral Mucositis and Body Weight Loss for Head and Neck Cancer Patients Treated with Chemoradiotherapy]. Mizumachi, T., Kano, S., Homma, A., et al.[2019]

Patients with head and neck cancer often face long-term challenges with food and eating even nine months after radiotherapy, affecting their physical, psychological, and social well-being.

Support and information are crucial for helping these patients adapt to new eating habits and improve their quality of life, highlighting the need for a holistic approach in follow-up care by healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The experience of food, eating and meals following radiotherapy for head and neck cancer: a qualitative study. Ottosson, S., Laurell, G., Olsson, C.[2022]

Head and neck cancer patients (n = 114) often did not meet the recommended dietary intakes for essential vitamins and minerals throughout their treatment, indicating a need for improved nutritional support.

Patients who consumed more oral nutritional supplements (ONS) had higher micronutrient intakes and Nutrition Impact Scores, but they also experienced greater weight loss, suggesting that while ONS can help with nutrient intake, they may not prevent weight loss during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Head and Neck Cancer Patients Do Not Meet Recommended Intakes of Micronutrients without Consuming Fortified Products. Nejatinamini, S., Kubrak, C., Álvarez-Camacho, M., et al.[2019]

This pilot study aims to evaluate the effectiveness of early oral nutritional supplements (ONSs) enriched with immunonutrients in head and neck cancer patients undergoing chemoradiotherapy, focusing on treatment tolerance, toxicity, and overall health outcomes.

The research is designed as a randomized controlled trial, which could provide valuable insights into the potential benefits of immunonutrition in improving quality of life and clinical outcomes during cancer treatment, although current evidence remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of immunonutrition in improving tolerance to chemoradiotherapy in patients with head and neck cancer, receiving nutritional counseling: study protocol of a randomized, open-label, parallel group, bicentric pilot study. Caccialanza, R., Cereda, E., Klersy, C., et al.[2022]

A pilot study involving seven participants (four patients and three caregivers) showed that a cooking class intervention improved dietary choices and cooking confidence among head and neck radiotherapy patients, despite a decline in taste sensation.

Participants reported increased preference for healthy foods and made positive dietary changes, such as choosing fresh produce and healthier cooking methods, indicating the potential effectiveness of culinary medicine interventions in supporting nutritional status in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Eat to Live"-Piloting a Culinary Medicine Program for Head & Neck Radiotherapy Patients. Allen-Winters, S., Wakefield, D., Gaudio, E., et al.[2021]

Introducing fortified soft ice-cream to post-operative head and neck cancer patients significantly increased their satisfaction and compliance with oral-feeding regimes, with 77% rating the taste as excellent and 60% reporting symptom relief.

The ice-cream was safe for early post-operative use, providing a palatable and nutritious option that could benefit not only cancer patients but also others with swallowing difficulties, such as the elderly and stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Soft, fortified ice-cream for head and neck cancer patients: a useful first step in nutritional and swallowing difficulties associated with multi-modal management. Trinidade, A., Martinelli, K., Andreou, Z., et al.[2021]

In a study of 292 head and neck cancer patients undergoing chemoradiotherapy, the nutritional risk index (NRI) significantly decreased from an average of 110 before treatment to 99 after treatment, indicating a decline in nutritional status.

The pretreatment NRI was found to be a predictor of overall survival and treatment-related complications, suggesting that assessing nutritional risk could help identify patients at higher risk for adverse outcomes during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between nutritional risk index and outcomes for head and neck cancer patients receiving concurrent chemo-radiotherapy. Oh, J., Liu, A., Tran, E., et al.[2021]

In a study of 83 head and neck cancer patients undergoing radiotherapy, critical weight loss of 5% or more was linked to a higher number of unplanned hospital admissions for nutrition-related issues, highlighting the importance of monitoring weight during treatment.

Higher baseline BMI and younger age were associated with greater weight loss during radiotherapy, while enteral nutrition (EN) use helped stabilize weight, suggesting that nutritional interventions could be crucial in preventing severe weight loss and related hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional parameters associated with hospital admissions in patients being treated for head and neck cancer. Duffy, AM., Halaki, M., Spigelman, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12068514/

The impact of immunonutrition in head and neck cancer ... Studies comparing immunonutrition with standard care were analysed for outcomes including fistula formation, wound infections, other infections, and length of ...

2. withpower.com withpower.com/trial/nutritional-optimization-for-head-and-neck-cancer-c64c1

Nutritional Optimization for Head and Neck Cancer Nestle IMPACT AR is unique because it is an oral nutritional supplement specifically enriched with immunonutrients, which may help improve treatment tolerance ...

3. researchgate.net researchgate.net/publication/391678171_The_impact_of_immunonutrition_in_head_and_neck_cancer_surgery_a_systematic_review_with_meta-analysis

The impact of immunonutrition in head and neck cancer ... Results. Immunonutrition significantly reduced postoperative fistulas and shortened hospital stays compared to standard care. The impact on ...

4. nestlemedicalhub.com nestlemedicalhub.com/products/impact-advanced-recovery

IMPACT Advanced Recovery® Drink IMPACT Advanced Recovery specially formulated to support the immune system after major surgery. Proven to help promote better outcomes in patients.

5. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(22)00671-2/pdf

Immunonutrition in head and neck cancer patients undergoing ... Thus, the lack of effectiveness could have been related to the chronic insufficient protein intake during CRT in the immunomodulating supplement group. In our ...

6. nestlenutritionstore.com nestlenutritionstore.com/impact-advanced-recoveryr.html

Nestlé Health Science Impact Advanced Recovery® ... Impact® formulas have been studied in dozens of clinical trials and thousands of patients, and have been shown to help promote better outcomes in patients ...

7. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010954.pub2/references

Immunonutrition for patients undergoing surgery for head ... Effect of perioperative immuno‐enhanced enteral nutrition on inflammatory response, nutritional status, and outcomes in head and neck cancer patients undergoing ...