Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000877482
Ethics application status
Approved
Date submitted
27/06/2016
Date registered
5/07/2016
Date last updated
5/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Prospective Cohort Study to Assess Body Composition as a Predictor of Outcomes in Pancreatic Cancer
Scientific title
A Prospective Cohort Study to Assess Body Composition as a Predictor of Outcomes in Pancreatic Ductal Adenocarcinoma
Secondary ID [1] 289549 0
Nil Known
Universal Trial Number (UTN)
U1111-1184-7244
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Ductal Adenocarcinoma 299274 0
Condition category
Condition code
Cancer 299274 299274 0 0
Pancreatic

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
This is an observational study, tracking muscle mass and strength during standard of care chemotherapy treatment. The muscle mass will be measured on standard of care CT scans. Muscle function will be assessed using grip strength measurement (1 minute) and peak expiratory flow measurement (2 minutes). An anorexia questionnaire will also be provided (2 minutes)
Intervention code [1] 295145 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298751 0
Chemotherapy toxicity (occurrence of adverse event gr3 or 4), assessed by review of medical records
Timepoint [1] 298751 0
diagnosis, 3 months and 6 months
Secondary outcome [1] 325133 0
Survival (by review of medical records)
Timepoint [1] 325133 0
at diagnosis (baseline), 3 months 6 months
Secondary outcome [2] 325186 0
Skeletal muscle volume (measured on standard of care CT scans)
Timepoint [2] 325186 0
at diagnosis, 3 months & 6 months
Secondary outcome [3] 325187 0
skeletal muscle strength (peak expiratory flow + handgrip strength)
Timepoint [3] 325187 0
at diagnosis, 3 months and 6 months
Secondary outcome [4] 325245 0
Anorexia as measured by the "Functional Assessment of Anorexia and Cachexia Therapy" questionnaire
Timepoint [4] 325245 0
diagnosis, 3 months, 6 months

Eligibility
Key inclusion criteria
-Adult
-Pancreatic ductal adenocarcinoma
-Diagnosed with pancreatic cancer within the last month
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Neuromuscular disease

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Number of participants required was determined using a power calculation, based on a similar study, which examined breast cancer patients on Capcitabine. This calculation was based of a power or 20%, and effect size of 30%, and a p value <0.05 required to be deemed statistically significant. All data will be analysed using GraphPad Prism 6 for Mac OS X (GraphPad Software, San Diego, CA, USA). Categorical data will be assessed for statistical significance using Chi square test. Continuous data will be tested for normality using D’Agostino & Pearson omnibus normality test. When only two groups of data are being compared the unpaired t-test or Mann-Whitney test will used. The unpaired t-test, with Welch’s correction to allow for comparison of groups with different standard deviations, will be used for data with Gaussian distribution (parametric data), and the Mann-Whitney test will be used for analysis of non-parametric data. When there are more than two groups being compared the ordinary one-way analysis of variance (ANOVA) and Kruskal-Wallis ANOVA will be used. Parametric data was analysed using an ordinary one-way ANOVA and non-parametric data will be analysed using the Kruskal-Wallis ANOVA. When a significant result was determined from either ANOVA test, the unpaired t-test or Mann-Whitney test was used, depending of distribution of the data, to compare each of the groups. For all analysis, a p value of <0.05 was considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
22/02/2017
Actual
Date of last data collection
Anticipated
7/04/2017
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6026 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 6027 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 13476 0
3144 - Malvern
Recruitment postcode(s) [2] 13477 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 293924 0
Hospital
Name [1] 293924 0
Monash Medical Centre
Country [1] 293924 0
Australia
Primary sponsor type
Hospital
Name
Monash Health
Address

246 Clayton road
Clayton, Vic
3168
Country
Australia
Secondary sponsor category [1] 292747 0
University
Name [1] 292747 0
Monash University
Address [1] 292747 0
Wellington Rd & Blackburn Rd, Clayton VIC 3800
Country [1] 292747 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295342 0
Monash Health Low Risk Human Ethics Comittee
Ethics committee address [1] 295342 0
246 Clayton Rd
Clayton, Vic
3168
Ethics committee country [1] 295342 0
Australia
Date submitted for ethics approval [1] 295342 0
05/02/2016
Approval date [1] 295342 0
25/02/2016
Ethics approval number [1] 295342 0
LNR/16/MonH/27

Summary
Brief summary
The primary purpose of this trial is to evaluate the link between body composition and outcomes in pancreatic cancer. Who is it for? You may be eligible to participate in this study if you are aged 18 or over and have been diagnosed with pancreatic ductal adenocarcinoma within the last month. Study details All participants enrolled in this study will complete a number of assessments including hand grip strength testing, a questionnaire and lung function tests at enrolment and 3 and 6 months later. The researchers will also require access to CT scans which have been collected as a part of your cancer management. It is hoped that the findings from this study will inform researchers on the links between muscle mass and function, and cancer outcomes of chemotherapy toxicity and survival.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66954 0
Dr Gregory Moore
Address 66954 0
Department of Gastroenterology
Monash Medical Centre
246 Clayton Rd
Clayton, Vic
3168
Country 66954 0
Australia
Phone 66954 0
+61395946666
Fax 66954 0
Email 66954 0
[email protected]
Contact person for public queries
Name 66955 0
Miss Julia Freckelton
Address 66955 0
Department of Gastroenterology
Monash Medical Centre
246 Clayton Rd
Clayton, Vic
3168
Country 66955 0
Australia
Phone 66955 0
+61395946666
Fax 66955 0
Email 66955 0
[email protected]
Contact person for scientific queries
Name 66956 0
Miss Julia Freckelton
Address 66956 0
Department of Gastroenterology
Monash Medical Centre
246 Clayton Rd
Clayton, Vic
3168
Country 66956 0
Australia
Phone 66956 0
+61395946666
Fax 66956 0
Email 66956 0
[email protected]

No information has been provided regarding IPD availability


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.