Resource® Support Plus for Malnutrition in Head and Neck Cancer Patients

Overseen By Vickie Baracos

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Nasogastric tube, Brain metastases, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special diet plan to help head and neck cancer patients eat enough. The diet includes two types of medical foods designed to provide necessary calories and nutrients, making it easier for patients to maintain their energy levels.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is Resource® Support Plus safe for humans?

The research does not provide specific safety data for Resource® Support Plus, but it highlights the importance of nutritional support in reducing complications for head and neck cancer patients. Nutritional interventions, including oral nutritional supplements, are generally considered beneficial and safe for improving patients' nutritional status. ^{1 2 3 4 5}

How is Multimodal Nutrition Therapy different from other treatments for malnutrition in head and neck cancer patients?

Multimodal Nutrition Therapy is unique because it focuses on providing comprehensive nutritional support before and during cancer treatment, which can help reduce complications and improve patient outcomes. This approach is particularly important for head and neck cancer patients who are often malnourished, and it involves a multidisciplinary team to ensure continuous and tailored nutritional care. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Multimodal Nutrition Therapy, Resource® Support Plus for malnutrition in head and neck cancer patients?

Research shows that improving nutrition in head and neck cancer patients can lead to better treatment outcomes and reduce side effects. Studies highlight the importance of nutrition care, including immunonutrition, to support patients undergoing cancer treatment. ^{10 11 12 13 14}

Who Is on the Research Team?

Vickie Baracos

Principal Investigator

Cross Cancer Institute, Alberta Health Services

Are You a Good Fit for This Trial?

This trial is for adults over 18 with squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx planning to undergo radical radiotherapy. They must be able to eat orally and have a performance status indicating they can carry out some activity. Excluded are those with certain other cancers, on conflicting trials, using tube feeding, having conditions affecting nutrient metabolism/absorption, untreated brain metastases, severe chronic illnesses or allergies to trial supplement ingredients.

Inclusion Criteria

I can eat and drink on my own without help.

I have a confirmed diagnosis of squamous cell carcinoma in the mouth or throat area and will undergo intensive radiotherapy.

Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up

Exclusion Criteria

I have brain metastases that haven't been treated, or I've had treatment without current symptoms.

Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures

Life expectancy <6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multimodal oral nutrition therapy or standard care during cancer treatment

7 weeks

Weekly consultations with a specialist oncology Registered Dietitian

Crossover Treatment

All patients receive the intervention arm; patients on standard care cross over to the intervention

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Nutrition Therapy
• Resource® Support Plus

Trial Overview The study tests if multimodal nutrition therapy helps patients maintain their calorie intake during cancer treatment. It compares the average energy consumed by patients receiving primary nutrition intervention plus adjuvant therapy (Resource® Support Plus) against a control group throughout their treatment period.

How Is the Trial Designed?

Group I: Multimodal Nutrition Therapy Experimental Treatment 1 Intervention

To assess a multimodal nutrition therapy (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment. The regimen consists of 2 medical foods, each taken on an unrestricted basis (as and when preferred by each patient). Resource® Support Plus, a nutritionally complete Medical Food specifically for the dietary management of oncology patients with (risk of) malnutrition. BOOST® Soothe, a Medical Food formulated as a clear oral nutritional supplement for cancer patients with sensory alterations or oral discomfort due to cancer treatments, in particular chemo- and/or radiotherapy.

Group II: Standard of Care Active Control 1 Intervention

In this setting patients rely on oral dietary intake. Ordinary, commercially available ingredients and food products are consumed. The standard of care includes weekly consultation with specialist oncology Registered Dietitian.

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Published Research Related to This Trial

The Eating As Treatment (EAT) program, which trains dietitians to use psychological techniques, significantly improved nutritional status in head and neck cancer patients undergoing radiation therapy, as evidenced by better scores on the Patient-Generated Subjective Global Assessment at the end of treatment.

Patients receiving the EAT intervention experienced not only improved nutrition but also a higher likelihood of being well-nourished, less weight loss, fewer treatment interruptions, lower depression scores, and a better quality of life compared to those receiving standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03). Britton, B., Baker, AL., Wolfenden, L., et al.[2019]

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]

Citations

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

Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03). [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Immunonutrition in Head and Neck Cancer Patients Undergoing Cancer Treatment - A Systematic Review. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

"Completely and utterly flummoxed and out of my depth": patient and caregiver experiences during and after treatment for head and neck cancer-a qualitative evaluation of barriers and facilitators to best-practice nutrition care. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

A descriptive review of the factors contributing to nutritional compromise in patients with head and neck cancer. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Evaluation of a novel pre-treatment model of nutrition care for patients with head and neck cancer receiving chemoradiotherapy. [2022]

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

Nutritional management of the head and neck cancer patient. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Toxicities Caused by Head and Neck Cancer Treatments and Their Influence on the Development of Malnutrition: Review of the Literature. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Pre-therapeutic nutritional assessment for predicting severe adverse events in patients with head and neck cancer treated by radiotherapy. [2022]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Consensus and clinical recommendations for nutritional intervention for head and neck cancer patients undergoing chemoradiotherapy in Taiwan. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

[Value of a nutrition score in patients with advanced carcinomas in the area of the head and neck]. [2019]

12. China pubmed.ncbi.nlm.nih.gov

Whole-course nutritional support therapy and indicators in head and neck cancer surgery. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Dietary and nutritional needs of patients undergoing therapy for head and neck cancer. [2019]

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

Nutritional assessment of the head and neck cancer patient. [2019]