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

Trial Summary

What is the purpose of this trial?

To determine whether nutritional optimization in head and neck cancer patients undergoing major surgery will decrease post-operative wound complications. The Investigators hypothesize that nutritional supplementation with Nestle Impact Advanced Recovery (AR) will decrease the rate of wound complications after surgery

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.

What data supports the effectiveness of the treatment Nestle IMPACT AR for head and neck cancer patients?

The research suggests that head and neck cancer patients often struggle to meet their nutritional needs, and fortified products like oral nutritional supplements can help improve their intake of essential nutrients. This implies that treatments like Nestle IMPACT AR, which are designed to provide nutritional support, may be beneficial in helping these patients meet their dietary requirements. ^{1 2 3 4 5}

Is the nutritional supplement Impact AR safe for humans?

The available research does not provide specific safety data for Impact AR, but it suggests that oral nutritional supplements, including those enriched with immunonutrients, are generally safe and beneficial for head and neck cancer patients, especially during treatment. ^{1 4 5 6 7}

How is the treatment Nestle IMPACT AR different from other treatments 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 and reduce side effects during chemoradiotherapy for head and neck cancer, compared to standard nutritional blends. ^{1 5 6 7 8}

Research Team

Barry Wenig, MD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The experience of food, eating and meals following radiotherapy for head and neck cancer: a qualitative study. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Nutritional parameters associated with hospital admissions in patients being treated for head and neck cancer. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Association between nutritional risk index and outcomes for head and neck cancer patients receiving concurrent chemo-radiotherapy. [2021]

4. Germany 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Head and Neck Cancer Patients Do Not Meet Recommended Intakes of Micronutrients without Consuming Fortified Products. [2019]

6. England 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. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

"Eat to Live"-Piloting a Culinary Medicine Program for Head & Neck Radiotherapy Patients. [2021]

8. Japan 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]. [2019]