Nutritional Supplementation in Head and Neck Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this trial
The purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and control group over the duration of cancer treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Male or female
≥18 years of age
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
Disqualifiers
Fed by nasogastric tube, gastrostomy or total parenteral nutrition
Cancer of the nasopharynx, thyroid or salivary gland
Life expectancy <6 months.
A known hypersensitivity / allergy to the investigational product or to any ingredient in their formulations (e.g. Milk/Lactose, Fish).
Trial design
Design model
Crossover
Treatments tested in this trial
Resource® Support Plus
Other interventionNestlé Resource Support Plus® is a high energy- and protein-density Medical Food enriched with omega 3 polyunsaturated fatty acids. This is a nutritionally complete formula, in an easy to swallow, palatable, concentrated low volume, available in 2 flavours optimized for cancer patients undergoing chemotherapy and/or radiation in taste tests. It provides in a 125 mL serving: 250 kcal, 11.5 g protein and 0.95g of omega-3 fatty acid (eicosapentaenoic acid, EPA).
Treatment groups
81 Participants
are divided into 2 treatment groupsGroup A: Multimodal Nutrition TherapyExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in mean cumulative energy intake
Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14).
Time frame
Up to 14 weeksSecondary outcomes
1
Change in mean cumulative protein take
Energy intake is calculated from a one-day diet record in which the patient lists the identity and quantity of all foods and beverages consumed in the designated 24 hour time period at the end of each week (Baseline - Week 14)
Time frame
Up to 14 Weeks2
Change in body weight (kg)
Change in weight (kg) from the previous week.
Time frame
Baseline-Week 143
Change in Nutritional blood biomarkers
A sample of blood will be collected for albumin, absolute neutrophil count, lymphocyte count, C-reactive protein, standard complete blood count-differential White Blood cell count and to measure serum CRP and albumin
Time frame
Baseline measures will be compared to levels at weeks 7 and 144
Head and Neck Symptom Checklist
A survey tool for HNC patient self-assessment of the presence and degree of interference with eating, over the past 3 days, of 17 symptoms known to impact dietary intake. Scores range from 34 to 170 pts, where higher scores reflect a greater presence and interference with eating. Completed at weeks 0, 4, 7, 11, 14
Time frame
Up to 14 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov