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Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

81 Participants Needed

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

Overseen ByVickie Baracos

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AHS Cancer Control Alberta

Disqualifiers: Nasogastric tube, Brain metastases, others

Stay on Your Current MedsYou can continue your current medications while participating

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

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special nutrition plan can help head and neck cancer patients maintain adequate calorie intake during treatment. The study tests a combination of two medical foods, including Resource® Support Plus, designed to meet nutritional needs during chemo-radiotherapy. One group will use these medical foods, while the other will follow regular meals with dietitian support. Individuals with head and neck squamous cell carcinoma who can eat by mouth and are undergoing radiation therapy may qualify for this trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

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

Research has shown that nutritional support can help reduce complications in patients with head and neck cancer. Although specific safety data for Resource® Support Plus is not available, nutrition therapy is generally considered safe. BOOST® Soothe, another part of the treatment, is designed to be gentle for patients experiencing taste changes or mouth discomfort due to cancer treatments.

As this study is in an early phase, researchers are still assessing the treatment's safety. However, medical foods like Resource® Support Plus and BOOST® Soothe are formulated for individuals with special nutritional needs, suggesting they are likely well-tolerated. Prospective participants should discuss any concerns with their healthcare provider.¹ ² ³ ⁴ ⁵

Why are researchers excited about this trial's treatments?

Researchers are excited about Multimodal Nutrition Therapy for head and neck cancer patients because it is specifically designed to maintain oral dietary intake during chemo-radiotherapy by addressing malnutrition and oral discomfort. Unlike the standard of care, which relies on ordinary foods and dietitian consultations, this therapy uses two tailored medical foods: Resource® Support Plus, a complete nutritional option for cancer patients with malnutrition risk, and BOOST® Soothe, which helps ease sensory changes and oral discomfort from treatments. This targeted approach aims to better support patients' nutritional needs and improve their overall treatment experience.

What evidence suggests that multimodal nutrition therapy is effective for malnutrition in head and neck cancer patients?

This trial will compare a multimodal nutrition therapy, including Resource® Support Plus and BOOST® Soothe, with the standard care for patients with head and neck cancer. Research has shown that combining nutrition therapies like Resource® Support Plus and BOOST® Soothe can improve nutrition in these patients. One study found that patients experienced better nutrition and were less likely to lose weight during treatment. This therapy ensures patients receive enough calories, crucial because cancer treatments often make eating difficult. BOOST® Soothe is specially formulated to ease mouth discomfort and taste changes common during chemotherapy and radiation. Overall, evidence suggests that this approach can help maintain a patient's nutrition during cancer treatment, potentially leading to better overall health outcomes.¹ ² ⁶ ⁷ ⁸

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

See 2 more

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

See 5 more

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?

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal Nutrition TherapyExperimental Treatment1 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 CareActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

AHS Cancer Control Alberta

Lead Sponsor

Trials

188

Recruited

26,900+

Published Research Related to This Trial

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]

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]

Citations

1.withpower.comwithpower.com/trial/phase-2-squamous-cell-carcinoma-of-the-oral-cavity-11-2022-33346

Resource® Support Plus for Malnutrition in Head and Neck ...Patients receiving the EAT intervention experienced not only improved nutrition but also a higher likelihood of being well-nourished, less weight loss, fewer ...

2.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC7102400/

Evidence-Based Support for Nutrition Therapy in Head and ...This article aims to review the current nutrition literature pertaining to H&N cancer patients and to present evidence-based strategies for nutritional support.

3.sciencedirect.comsciencedirect.com/science/article/pii/S246829422030068X

Nutritional outcomes in head and neck cancer patientsThe present study shows that, in patients with head and neck cancer, intensive care (weekly dietetic counseling during RT) did not have an impact on weight loss ...

4.clinicalnutritionespen.comclinicalnutritionespen.com/article/S2405-4577(23)02191-5/fulltext

Nutritional prehabilitation in head and neck cancerNutritional and physical prehabilitation interventions have a positive effect on the nutritional status and clinical outcomes of patients with head and neck ...

5.mdpi.commdpi.com/2072-6694/15/3/822

Systematic Review of Nutrition Interventions to Improve ...Randomized controlled trials utilizing nutrition interventions to improve outcomes in head and neck cancer patients undergoing treatment ...

6.sciencedirect.comsciencedirect.com/science/article/pii/S2405457723021915

Nutritional prehabilitation in head and neck cancerThe selected studies concern adults with head and neck tumours, not malnourished at the time of diagnosis, who undergo nutritional or physical prehabilitation.

7.nature.comnature.com/articles/s41415-022-5107-8

Malnutrition, nutrition support and dietary interventionMalnutrition is prevalent in patients with head and neck cancer (HNC) at diagnosis but can occur at any stage of the treatment pathway.

8.pmc.ncbi.nlm.nih.govpmc.ncbi.nlm.nih.gov/articles/PMC12396949/

A rapid review of nutrition and exercise approaches to ...A pilot study showed that nurse-led malnutrition screening and referral to multidisciplinary treatment for patients with head and neck cancer ...

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