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Resource® Support Plus for Malnutrition in Head and Neck Cancer Patients
Phase 2
Waitlist Available
Led By Vickie Baracos
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histopathologically confirmed primary squamous cell carcinoma of the oral cavity and oropharynx, larynx or hypopharynx, who have agreed to receive radical intent radiotherapy as primary treatment or adjuvant treatment post-surgery, with or without platinum chemotherapy
An Eastern Cooperative Oncology Group Performance Status of ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 30 days prior to start of treatment, week 14
Awards & highlights
Study Summary
This trial will test whether multimodal nutrition therapy can help cancer patients better tolerate treatment and improve their calorie intake.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may relate to allergic reactions due to ingredients in Resource® Support Plus such as milk/lactose or fish. Since it's nutritional support rather than medication being tested here, fewer side effects are expected compared to drug trials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed diagnosis of squamous cell carcinoma in the mouth or throat area and will undergo intensive radiotherapy.
Select...
I can perform daily activities with minimal assistance.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 30 days prior to start of treatment, week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 30 days prior to start of treatment, week 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in mean cumulative energy intake
Secondary outcome measures
Change in Nutritional blood biomarkers
Change in body weight (kg)
Change in computed-tomography (CT) defined skeletal muscle and fat mass)
+10 moreTrial Design
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.
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Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,131 Total Patients Enrolled
Vickie BaracosPrincipal InvestigatorCross Cancer Institute, Alberta Health Services
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can eat and drink on my own without help.I have brain metastases that haven't been treated, or I've had treatment without current symptoms.I am 18 years old or older.I have a confirmed diagnosis of squamous cell carcinoma in the mouth or throat area and will undergo intensive radiotherapy.I do not have any poorly controlled chronic illnesses like COPD, diabetes, or rheumatoid arthritis.I am fed through a tube or IV nutrition.My cancer is in the nasopharynx, thyroid, or salivary gland.I can perform daily activities with minimal assistance.I had a CT scan within the last 30 days or will have one before starting radiotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care
- Group 2: Multimodal Nutrition Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation still accepting participants?
"The clinical trial listing on clinicaltrials.gov indicates that recruitment for this medical study has ended, as the post was published December 1st 2022 and last updated May 13th 2022. Even though enrollment is closed, 8 other trials are currently inviting participants to join them in their research endeavours."
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Does Resource® Support Plus meet the approval of the Food and Drug Administration?
"Our team has rated Resource® Support Plus as having a safety level of 2, given that it is in its second phase and there are some collected data points to back the product's security but no evidence for efficacy."
Answered by AI
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