Back to resultsNutritional Supplementation in Head and Neck Cancers
Primary Purpose
Malnourishment, Nutritional Deficiency, Undernutrition
Status
Not yet recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Resource® Support Plus
Sponsored by
About this trial
This is an interventional treatment trial for Malnourishment focused on measuring Nutritional Support, Oral Nutritional Supplements
Eligibility Criteria
Inclusion Criteria:
- 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
- Capable of volitional oral nutritional intake at baseline.
- A diagnostic CT image taken with a maximum of 30 days before initiation of radical intent radiotherapy. If the CT scan history in the patient's clinical record does not include a study within this window, a baseline non-contrast enhanced CT abdomen will be conducted.
- Ability to maintain oral intake.
- An Eastern Cooperative Oncology Group Performance Status of ≤ 2
Exclusion Criteria:
- 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).
- Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
- Patients with untreated brain metastases (patients with previously resected and/or radiated brain metastases without neurologic symptoms are permitted).
- Poorly controlled chronic illnesses or other inflammatory diseases (e.g. COPD, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
- In the investigators' opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)
Sites / Locations
- Cross Cancer Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Multimodal Nutrition Therapy
Standard of Care
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)
Change in body weight (kg)
Change in weight (kg) from the previous week.
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
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
Taste and smell survey
A survey tool for patient self-assessment of the presence, characterization and severity of taste and smell alterations. This tool yields a 'chemosensory complaint score' of up to 16 (greatest severity of taste and smell alterations). Completed at weeks 0, 4, 7, 11, 14.
Medication use for pain
Use of pain medication will be captured weekly by a one- day pain medication log.
Percent oral intake from oral nutritional supplements
The volume (mL) of study products consumed will be determined from the weekly one-day diet record.
Product Sensory Assessment questionnaire
A product evaluation form for the Medical Nutrition products will be used to evaluate product overall sensory assessment, including acceptance and perception of characteristic product attributes that influence overall sensory acceptance. Medical Nutrition sensory acceptance will be evaluated by "overall liking" on the 9-point hedonic scale (1= dislike extremely; 9 = like extremely). Completed at weeks 0, 2, 4, 6, 8, 10, 12, 14.
Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S)
The FAACT is a validated Quality of Life Scale to capture patient experience of cancer related cachexia - anorexia. Completed at weeks 0, 4, 7,11, 14
Cumulative energy intake (kcal/kg BW)
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)
Cumulative protein take (g pro/kg BW)
Protein 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)
Change in computed-tomography (CT) defined skeletal muscle and fat mass)
Imaging for body composition (muscle, fat)
Tertiary hospital admission
Review of patient medical records for instances of hospitalization with date(s) of admission falling between baseline and week 14 of study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05379712
Brief Title
Nutritional Supplementation in Head and Neck Cancers
Official Title
A Randomized Open Label Trial of Multimodal Oral Nutritional Supplementation Versus Standard Care, to Prevent / Attenuate Malnutrition in Patients With Cancers of the Head and Neck Receiving (Chemo)-Radiotherapy Treatment.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
This will be an randomized, open label, parallel assignment study during cancer treatment (Baseline - Week 7 for Primary endpoint) comparing multimodal oral nutrition therapy versus standard care. Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).
The primary objective is to assess a multimodal nutrition therapy with two Medical Foods (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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnourishment, Nutritional Deficiency, Undernutrition
Keywords
Nutritional Support, Oral Nutritional Supplements
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Randomized (multimodal oral nutrition therapy versus standard care), open label, parallel assignment, during cancer treatment (Baseline - Week 7 for Primary endpoint). Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multimodal Nutrition Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Resource® Support Plus
Intervention Description
Nestlé 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).
Primary Outcome Measure Information:
Title
Change in mean cumulative energy intake
Description
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 weeks
Secondary Outcome Measure Information:
Title
Change in mean cumulative protein take
Description
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 Weeks
Title
Change in body weight (kg)
Description
Change in weight (kg) from the previous week.
Time Frame
Baseline-Week 14
Title
Change in Nutritional blood biomarkers
Description
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 14
Title
Head and Neck Symptom Checklist
Description
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 weeks
Title
Taste and smell survey
Description
A survey tool for patient self-assessment of the presence, characterization and severity of taste and smell alterations. This tool yields a 'chemosensory complaint score' of up to 16 (greatest severity of taste and smell alterations). Completed at weeks 0, 4, 7, 11, 14.
Time Frame
Up to 14 weeks
Title
Medication use for pain
Description
Use of pain medication will be captured weekly by a one- day pain medication log.
Time Frame
Up to 14 weeks
Title
Percent oral intake from oral nutritional supplements
Description
The volume (mL) of study products consumed will be determined from the weekly one-day diet record.
Time Frame
Up to 14 weeks
Title
Product Sensory Assessment questionnaire
Description
A product evaluation form for the Medical Nutrition products will be used to evaluate product overall sensory assessment, including acceptance and perception of characteristic product attributes that influence overall sensory acceptance. Medical Nutrition sensory acceptance will be evaluated by "overall liking" on the 9-point hedonic scale (1= dislike extremely; 9 = like extremely). Completed at weeks 0, 2, 4, 6, 8, 10, 12, 14.
Time Frame
Up to 14 weeks
Title
Functional Assessment of Anorexia-Cachexia Treatment (FAACT) 5 Question Anorexia/Cachexia subscale (AC/S)
Description
The FAACT is a validated Quality of Life Scale to capture patient experience of cancer related cachexia - anorexia. Completed at weeks 0, 4, 7,11, 14
Time Frame
Up to 14 weeks
Title
Cumulative energy intake (kcal/kg BW)
Description
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 weeks
Title
Cumulative protein take (g pro/kg BW)
Description
Protein 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 weeks
Title
Change in computed-tomography (CT) defined skeletal muscle and fat mass)
Description
Imaging for body composition (muscle, fat)
Time Frame
Within 30 days prior to start of treatment, Week 14
Title
Tertiary hospital admission
Description
Review of patient medical records for instances of hospitalization with date(s) of admission falling between baseline and week 14 of study.
Time Frame
Up to 14 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Capable of volitional oral nutritional intake at baseline.
A diagnostic CT image taken with a maximum of 30 days before initiation of radical intent radiotherapy. If the CT scan history in the patient's clinical record does not include a study within this window, a baseline non-contrast enhanced CT abdomen will be conducted.
An Eastern Cooperative Oncology Group Performance Status of ≤ 2
Exclusion Criteria:
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).
Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
Patients with untreated brain metastases (patients with previously resected and/or radiated brain metastases without neurologic symptoms are permitted).
Poorly controlled chronic illnesses or other inflammatory diseases (e.g. COPD, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
In the investigators' opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vickie Baracos
Phone
780-432-8232
Email
Vickie.Baracos@albertahealthservices.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vickie Baracos
Organizational Affiliation
Cross Cancer Institute, Alberta Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vickie Baracos
Phone
7804328232
Email
Vickie.Baracos@albertahealthservices.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Nutritional Supplementation in Head and Neck Cancers
We'll reach out to this number within 24 hrs