Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000295549
Ethics application status
Approved
Date submitted
8/02/2024
Date registered
21/03/2024
Date last updated
21/03/2024
Date data sharing statement initially provided
21/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of nutrition in individuals with pancreatic cancer
Scientific title
Assessing the feasibility of a dietetics intervention and nutritional evaluation for adults with pancreatic cancer
Secondary ID [1] 311496 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pancreatic cancer 332827 0
Condition category
Condition code
Cancer 329545 329545 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Enrolled participants will have the choice to attend an in-person dietetics consultation at their nearest Epworth HealthCare facility. However, if attending in-person is not convenient or feasible, telehealth consultations will be available. These virtual sessions can be conducted either over the phone or through Microsoft Teams. The frequency of follow-up consultations will be tailored based on the patient’s prognosis, treatment plan, and the health status as per ESPEN practical guidelines.

Dietetic assessment and review:
• BMI, PG-SGA (malnutrition) questionnaire, SARC-F (sarcopenia) questionnaire
• Clinical symptoms and situation: Including nausea, vomiting, bowel function, treatment plan and side effects (if applicable), operative plan (if applicable)
• Dietary intake:
- Review current dietary intake, changes/impacts from clinical situation, implementation of previous dietetic strategies (if applicable) using a food diary template designed specifically for this study.
- Assess whether meeting estimated energy and protein requirements in line with ESPEN guidelines for preventing/treating malnutrition pre-operatively.

Dietetic intervention:
• Strategies to maintain weight prior to systemic therapy and to enhance oral intake if currently suboptimal i.e., high calorie high protein meal fortification, oral nutrition supplements such as Fortisip®/Resource® will be measured via weight chart designed specifically for this study.
• Consideration of escalated nutrition support via artificial feeding if oral intake severely suboptimal or patient severely malnourished (liaise with treating team).
• Participants will be provided written handouts of the nutrition counselling session, as needed.
• They will also receive nutrition pamphlets to further highlight common side-effects of treatment, such as loss of appetite and weight loss. These are readily available resources located on the Jreissati Pancreatic Centre website: https://www.epworth.org.au/-/media/project/epworth/epworthweb/documents/services/jreissati-family-pancreatic-centre/pi2429-jpc-nutrition-guide-a5-v6-web.pdf

Frequency of follow-up
Follow-up appointments will be scheduled according to nutrition risk stratification at diagnosis/planning and pre/post therapy. For instance, participants with a PG-SGA assessment of ‘B’ or ‘C’ (i.e., malnourished) may require additional dietetic review to optimise their nutrition, compared to a participant with a PG-SGA 'A' assessment whose dietary intake is likely adequate. Individuals who are considered low risk (A assessment) will be followed-up every month. Those in moderate risk (B assessment) will be followed up via telehealth or clinic review every 1-2 weeks. Individuals at severe risk (C assessment) will require 1-2 telehealth/clinic reviews per week or inpatient admission. The frequency of these follow-ups will occur over a maximum duration of a year.
Intervention code [1] 327945 0
Treatment: Other
Comparator / control treatment
Clinical outcomes in the intervention group will be compared to historical / retrospective data of individuals who did not received out-patient dietetics support. Electronic medical records will be sourced from individuals diagnosed with pancreatic cancer at the Jreissati Pancreatic Centre from 2021-2023.
Control group
Historical

Outcomes
Primary outcome [1] 337336 0
To assess the feasibility of an out-patient dietetics program for individuals with pancreatic cancer.
Timepoint [1] 337336 0
Baseline and end of study (2 years post enrolment)
Secondary outcome [1] 431508 0
To determine the impact of dietetics counselling on quality of life.
Timepoint [1] 431508 0
Baseline (at enrolment), pre-determined timepoints (based on dietetics assessment according to clinical need), and at end of study (2 years post study enrolment).

We are unable to provide specific pre-determined timepoints as this will be assessed on an ongoing basis based on clinical need. Individuals who are considered low risk will be followed up every month. Those who are at moderate risk will be reviewed via telehealth/clinic appointments every 1-2 weeks, and individuals who present with severe risk will require 1-2 telehealth/clinic reviews per week or inpatient admission. All individuals will be followed up for a year.
Secondary outcome [2] 431509 0
To determine participant satisfaction with the dietetics counselling program.
Timepoint [2] 431509 0
Baseline (at enrolment), pre-determined timepoints (based on dietetics assessment according to clinical need), and at end of study (2 years post study enrolment).

We are unable to provide specific pre-determined timepoints as this will be assessed on an ongoing basis based on clinical need. Individuals who are considered low risk will be followed up every month. Those who are at moderate risk will be reviewed via telehealth/clinic appointments every 1-2 weeks, and individuals who present with severe risk will require 1-2 telehealth/clinic reviews per week or inpatient admission. All individuals will be followed up for a year.
Secondary outcome [3] 432594 0
To evaluate the incidence of malnutrition in individuals with pancreatic cancer.
Timepoint [3] 432594 0
Baseline (at enrolment), pre-determined timepoints (based on dietetics assessment according to clinical need), and at end of study (2 years post study enrolment).

We are unable to provide specific pre-determined timepoints as this will be assessed on an ongoing basis based on clinical need. Individuals who are considered low risk of malnutrition will be followed up every month. Those who are at moderate risk will be reviewed via telehealth/clinic appointments every 1-2 weeks, and individuals who present with severe risk will require 1-2 telehealth/clinic reviews per week or inpatient admission. Individuals will be followed up for a period of a year.
Secondary outcome [4] 432595 0
To evaluate the incidence of sarcopenia in individuals with pancreatic cancer.
Timepoint [4] 432595 0
Baseline (at enrolment), pre-determined timepoints (based on dietetics assessment according to clinical need), and at end of study (2 years post study enrolment).

We are unable to provide specific pre-determined timepoints as this will be assessed on an ongoing basis based on clinical need. Individuals who are considered low risk of sarcopenia will be followed up every month. Those who are at moderate risk will be reviewed via telehealth/clinic appointments every 1-2 weeks, and individuals who present with severe risk will require 1-2 telehealth/clinic reviews per week or inpatient admission. Individuals will be followed up for a period of a year.
Secondary outcome [5] 432596 0
To evaluate the incidence of cachexia in individuals with pancreatic cancer.
Timepoint [5] 432596 0
Baseline (at enrolment), pre-determined timepoints (based on dietetics assessment according to clinical need), and at end of study (2 years post study enrolment).

We are unable to provide specific pre-determined timepoints as this will be assessed on an ongoing basis based on clinical need. Individuals who are considered low risk of cachexia will be followed up every month. Those who are at moderate risk will be reviewed via telehealth/clinic appointments every 1-2 weeks, and individuals who present with severe risk will require 1-2 telehealth/clinic reviews per week or inpatient admission. Individuals will be followed up for a period of a year.
Secondary outcome [6] 432600 0
To determine the impact of dietetics counselling on treatment outcomes.
Timepoint [6] 432600 0
Baseline (at enrolment), pre-determined timepoints (based on dietetics assessment according to clinical need), and at end of study (2 years post study enrolment).

We are unable to provide specific pre-determined timepoints as this will be assessed on an ongoing basis based on clinical need. Individuals who are considered low risk of will be followed up every month. Those who are at moderate risk will be reviewed via telehealth/clinic appointments every 1-2 weeks, and individuals who present with severe risk will require 1-2 telehealth/clinic reviews per week or inpatient admission. All individuals will be followed up for a year.
Secondary outcome [7] 432602 0
To determine the impact of dietetics counselling on treatment outcomes.
Timepoint [7] 432602 0

Baseline (at enrolment), pre-determined timepoints (based on dietetics assessment according to clinical need), and at end of study (2 years post study enrolment).

We are unable to provide specific pre-determined timepoints as this will be assessed on an ongoing basis based on clinical need. Individuals who are considered low risk of will be followed up every month. Those who are at moderate risk will be reviewed via telehealth/clinic appointments every 1-2 weeks, and individuals who present with severe risk will require 1-2 telehealth/clinic reviews per week or inpatient admission. All individuals will be followed up for a year.
Secondary outcome [8] 432603 0
To determine the impact of dietetics counselling on treatment outcomes.
Timepoint [8] 432603 0
Baseline (at enrolment), pre-determined timepoints (based on dietetics assessment according to clinical need), and at end of study (2 years post study enrolment).

We are unable to provide specific pre-determined timepoints as this will be assessed on an ongoing basis based on clinical need. Individuals who are considered low risk of will be followed up every month. Those who are at moderate risk will be reviewed via telehealth/clinic appointments every 1-2 weeks, and individuals who present with severe risk will require 1-2 telehealth/clinic reviews per week or inpatient admission. All individuals will be followed up for a year.

Eligibility
Key inclusion criteria
Participants must meet all the following criteria:
- Aged at least 18 years at the time of consent
- Planned for systemic therapy
- Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements
- Confirmed histological or cytological diagnosis of pancreatic cancer.
- No later than one-month post commencement of systemic treatment, including chemotherapy, biological therapy, radiotherapy, or targeted therapy for pancreatic cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
- Has a life expectancy of greater or equal to 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants must not meet any of the following criteria:
- Currently enrolled in a weight management program, receiving nutritional counselling, or part of another nutrition-related study/program.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/04/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315784 0
Hospital
Name [1] 315784 0
Epworth HealthCare
Country [1] 315784 0
Australia
Primary sponsor type
Hospital
Name
Epworth HealthCare
Address
Country
Australia
Secondary sponsor category [1] 317910 0
None
Name [1] 317910 0
Address [1] 317910 0
Country [1] 317910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314643 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 314643 0
https://monashhealth.org/research/resources/resource-library/
Ethics committee country [1] 314643 0
Australia
Date submitted for ethics approval [1] 314643 0
15/01/2024
Approval date [1] 314643 0
20/02/2024
Ethics approval number [1] 314643 0

Summary
Brief summary
Malnutrition, sarcopenia, and cachexia are common concerns for patients with pancreatic cancer, causing increased risk of comorbidities and may affect their ability to respond to cancer treatments. This study aims to assess the feasibility and effectiveness of an out-patient dietetics program on nutritional status and quality of life in individuals with pancreatic cancer.

Who is it for?
You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with pancreatic cancer and you are due to begin your cancer therapy within the next month.

Study details
You will be assessed by a dietitian within the first month of your treatment. Basic health and nutrition information will be collected including your age, weight, cancer stage and treatment, symptoms impacting your nutrition (such as nausea, vomiting, or treatment side effects), and diet history.

Individual nutrition recommendations will be provided to optimise your nutritional intake, which might involve consuming oral nutrition supplements. If you have not started therapy, education will be provided regarding your upcoming treatment and how this might impact your nutrition afterwards. The number of times you will be seen by a dietitian will depend on your nutrition status and how much support you require.

You will be requested to complete questionnaires to help us understand your nutritional status, quality of life, and satisfaction with the dietetics program.

It is hoped this research will determine that dietary counselling for patients with pancreatic cancer is feasible and acceptable to these patients. This pilot study will assess whether there is potential benefit in delivering this service to a greater number of patients with pancreatic cancer in a larger randomised trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132258 0
Ms Bridget Sussex
Address 132258 0
Epworth HealthCare, 89 Bridge Road, Richmond 3121, Victoria
Country 132258 0
Australia
Phone 132258 0
+61 3 94260567
Fax 132258 0
Email 132258 0
bridget.sussex@epworth.org.au
Contact person for public queries
Name 132259 0
The Jreissati Pancreatic Centre
Address 132259 0
Epworth HealthCare, 89 Bridge Road, Richmond 3121, Victoria
Country 132259 0
Australia
Phone 132259 0
+61 3 94260567
Fax 132259 0
Email 132259 0
eh-jreissaticentre@epworth.org
Contact person for scientific queries
Name 132260 0
The Jreissati Pancreatic Centre
Address 132260 0
Epworth HealthCare, 89 Bridge Road, Richmond 3121, Victoria
Country 132260 0
Australia
Phone 132260 0
+61 3 94260567
Fax 132260 0
Email 132260 0
eh-jreissaticentre@epworth.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.