None listed
Conditions
Brief summary
Our study will assess the benefits of and oral supplement of swallowed milk-derived extracellular vesicles, for protection for patients undergoing radiotherapy for a head and neck cancer. Safety and efficacy study of a dairy-derived supplement containing extracellular vesicles as a protective strategy for those undergoing radiotherapy for head and neck cancer. participants will take supplements orally during treatment as either a) placebo, b) single dose EVs without peptide enhancer, c) multiple dose EVs without peptide enhancer, d) single dose EVs with peptide enhance or e) multiple dose EVs with peptide enhancer. We will measure the effects of treatment in relation to swallowing by questionnaires, endoscopy and videofluoroscopic swallowing studies for 12 months following treatment.
Interventions
Participants will be grouped by exposure as follows:
Group 1: Sham milk extracellular vesicles (mEVs) (CONTROL COMPARATOR GROUP)
Group 2: Milk EVs - unloaded (lacking peptide string), single dose
Group 3: Milk EVs - unloaded, multiple dose (six in total)
Group 4: Milk EVs - loaded (with peptide string), single dose
Group 5: Milk EVs - loaded, multiple dose (six in total)
Unloaded milk EVs are naturally occurring extracellular vesicles found in milk that can be filtrated out. The Gourdie lab ha
Participants will be grouped by exposure as follows: Group 1: Sham milk extracellular vesicles (mEVs) (CONTROL COMPARATOR GROUP) Group 2: Milk EVs - unloaded (lacking peptide string), single dose Group 3: Milk EVs - unloaded, multiple dose (six in total) Group 4: Milk EVs - loaded (with peptide string), single dose Group 5: Milk EVs - loaded, multiple dose (six in total) Unloaded milk EVs are naturally occurring extracellular vesicles found in milk that can be filtrated out. The Gourdie lab has been able to label these milk EVs with a portion of the carboxy terminal of connexin 43 (named alpha-CT11) which enables absorption of the milk EV from the gut without EV destruction. This enables the mEVs to be given as an oral supplement. Each participant will drink orally 150mL of milk-product for each dose on the first day of treatment and then subsequently weekly if they are in those allocated groups eg. Fraction 1, Fraction 6, Fraction 11, Fraction 16, Fraction 21, Fraction 26 if they are having a dose each week of radiotherapy. Radiotherapy is given in "fractions" (daily doses, five days per week, usually for six or seven weeks, therefore for either 30 or 35 fractions). In the event that participants have a feeding tube and are not drinking orally, the dose can be administered via the feeding tube to the gut. The milk-product will be provided by our Researcher who will observe ingestion or instillation as appropriate. Aside from ingestion of the milk-product, participants will complete patient-rating questionnaires on each visit.
Sponsors
Te Whatu Ora Waitemata
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Subject undergoing radiotherapy treatment (minimum 6 weeks of primary or adjuvant radiotherapy) for head and neck cancer (subsites: oral, oropharyngeal, nasopharyngeal, hypopharyngeal, laryngeal, metastatic skin squamous cancer to neck nodes) 2) Age 18 years and older 3) Ability to understand the informed consent and comply with follow-up, as evidenced by appropriate question responses, and comments during the initial evaluations.
Exclusion criteria
1) Oropharyngeal dysphagia not related to cancer treatment, or pre-existing oropharyngeal dysphagia as defined through personal history or diagnosis of neurological, autoimmune, infective, or inflammatory illnesses known to cause OPD. 2) Esophageal phase dysphagia as defined through personal history and/or documented diagnosis of esophageal dysmotility, hiatal hernia, eosinophilic esophagitis, malignant esophageal disease, erosive peptic esophagitis, and/or systemic disease affecting the esophagus. 3) Milk or lactose allergy or intolerance 4) Age < 18 years 5) Previous head and neck radiotherapy treatment 6) Patients with current, at the time of evaluation, and/or documented history of airway obstruction, as evidenced on endoscopy. 7) Patients receiving only parenteral nutrition or exclusively on feeding tube.
Outcome results
None listed