Resource® Support Plus for Malnutrition in Head and Neck Cancer Patients
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multimodal oral nutrition therapy or standard care during cancer treatment
Crossover Treatment
All patients receive the intervention arm; patients on standard care cross over to the intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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
Published Research Related to This Trial
Citations
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 ...
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.
Nutritional outcomes in head and neck cancer patients
The 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 ...
Nutritional prehabilitation in head and neck cancer
Nutritional and physical prehabilitation interventions have a positive effect on the nutritional status and clinical outcomes of patients with head and neck ...
Systematic Review of Nutrition Interventions to Improve ...
Randomized controlled trials utilizing nutrition interventions to improve outcomes in head and neck cancer patients undergoing treatment ...
Nutritional prehabilitation in head and neck cancer
The selected studies concern adults with head and neck tumours, not malnourished at the time of diagnosis, who undergo nutritional or physical prehabilitation.
Malnutrition, nutrition support and dietary intervention
Malnutrition is prevalent in patients with head and neck cancer (HNC) at diagnosis but can occur at any stage of the treatment pathway.
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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