Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000323426
Ethics application status
Approved
Date submitted
22/05/2007
Date registered
18/06/2007
Date last updated
18/06/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of fish oil containing eicosapentaenoic acid (EPA) on weight loss and cachexia in pancreatic cancer patients undergoing cancer chemotherapy.
Scientific title
Effects of fish oil containing eicosapentaenoic acid (EPA) on weight loss and cachexia in pancreatic cancer patients undergoing cancer chemotherapy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Weight loss. 1869 0
Cachexia. 1870 0
Pancreatic cancer chemotherapy. 1871 0
Changes in body composition. 1872 0
Condition category
Condition code
Cancer 1966 1966 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, randomised, placebo controlled clinical trial. All patients will be receiving the same standard chemotherapy regimen of Gemcitabine (1000mg/m2 iv D1, 8, 15, Q4 weekly). Treatment/placebo administration will be carried out during the first 16 weeks of the chemotherapy.
Body composition measurements, anthropometry and QL measurements will be carried out prior to chemotherapy and then at 4, 8, 12 and 16 weeks post-chemotherapy.
Intervention code [1] 1774 0
Treatment: Drugs
Comparator / control treatment
EPA (2.7g/day) / placebo will be given orally as soft gel capsules for 16 weeks commencing on the first day of chemotherapy.
Control group
Placebo

Outcomes
Primary outcome [1] 2780 0
The primary objective of the trial is to assess the changes in body composition and the effects of EPA in pancreatic cancer patients undergoing cancer chemotherapy. It is hypothesised that the EPA will reduce weight loss and cachexia in this group of patients.
Timepoint [1] 2780 0
Body composition measurements will be carried out at 0 (baseline), 4, 8, 12, and 16 weeks post-chemotherapy to assess any changes in weight and the components of weight (ie fat, water, and protein).
Secondary outcome [1] 4693 0
The daily administration of EPA may also have possible improvement in Quality of Life and survival.
Timepoint [1] 4693 0
The quality of life is assessed using the EORTC QLQ-C30 and PAN-26 quality of life questionnaires at 0 (base-line), 4, 8, 12, and 16 weeks post-chemotherapy.
Secondary outcome [2] 4694 0
The daily administration of EPA may reduce chemotherapy-induced toxicities.
Timepoint [2] 4694 0
Similarly, the chemotherapy induced toxicity (white blood cell and neutrophil counts) will be measured at 0 (base-line), 4, 8, 12, and 16 weeks post-chemotherapy.

Eligibility
Key inclusion criteria
1.Patients with a pathologic diagnosis of pancreas cancer that is locally advanced and unresectable, partially resected or metastatic;2.Signed informed consent.3.Patients with the ability to understand the nature of the project and to provide informed consent;4.Patients with ECOG performance status of less than or equal to 2, as determined by the referring physician;5.Patients who are greater than 4 weeks post-operative or post radiotherapy.6.Adequate haematologic and biochemical functioning, including liver function tests, permitting suitability for Gemcitabine chemotherapy.7.Life expectancy of 12 weeks.8.Ability to complete the scheduled body composition measures.9.Ability to complete the QL questionnaire.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Patients who have received and/or are receiving chemotherapy for pancreatic cancer;2.Progressing or untreated brain metastases.3.Pregnant and lactating women;4.Serious intercurrent medical illness or psychological, familial, sociological, geographical, or other concomitant conditions that do not permit adequate follow-up and compliance with the study protocol.5.Participation in clinical trials of other experimental agents within 30 days of study entry.6.Pregnant or lactating women or women of childbearing potential not using effective contraception.7.Radiotherapy within 4 weeks.8.Surgery within 6 weeks.Both male and female patients will be recruited for this trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will take place centrally at Royal North Shore Hospital's Department of Medical Oncology by computer at a 1:1 ratio to receive Gemcitabine alone (plus placebo) or combined with EPA. Eligible patients will be stratified at inclusion according to age (>=70 and <70 years), ECOG performance status (0,1,2), and locally advanced or metastatic. After having checked the patient’s eligibility criteria, the investigators will request patient randomisation by phone or fax.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation logs will be used for each stratum. Patients will be allocated to his/her stratum and will be randomly assigned to the therapeutic arm according to the next consecutive number in the stratum log.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The patients, all investigators, and all staff (medical and non-medical) looking after the patients are blinded to the trial. Only the oncology data manger randomising the patients and the pharmacist dispensing the capsules are not blinded in this trial.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2106 0
Charities/Societies/Foundations
Name [1] 2106 0
CanSur Research Fund
Country [1] 2106 0
Australia
Primary sponsor type
Individual
Name
Professor Ross C Smith
Address
Country
Secondary sponsor category [1] 1913 0
Individual
Name [1] 1913 0
Mr A Aslani
Address [1] 1913 0
Country [1] 1913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3897 0
Royal North Shore Hospital
Ethics committee address [1] 3897 0
Ethics committee country [1] 3897 0
Australia
Date submitted for ethics approval [1] 3897 0
Approval date [1] 3897 0
14/06/2004
Ethics approval number [1] 3897 0
0303-067M

Summary
Brief summary
Fish oils containing eicosapentaenoic acid (EPA) have been shown to prevent and reverse cancer-induced weight loss and cachexia by maintaining lean body mass. However, there have not been direct measurements of the components of weight loss nor the changes in body composition during and after the reversal. In addition, the reversal of weight loss and cachexia has not been investigated in patients with pancreatic cancer during chemotherapy. The RNS Hospital has the unique facilities to be able to directly, accurately and non-invasively measure these changes. We believe that the positive effects of EPA during chemotherapy will reduce weight loss, improve the quality of life as well as reducing chemotherapy-induced toxicities.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27877 0
Address 27877 0
Country 27877 0
Phone 27877 0
Fax 27877 0
Email 27877 0
Contact person for public queries
Name 10963 0
Professor Ross C Smith
Address 10963 0
Suite 5, Level 5
North Shore Private Hospital
Westbourne Street
St Leonards, NSW 2065
Country 10963 0
Australia
Phone 10963 0
02-84253554
Fax 10963 0
Email 10963 0
[email protected]
Contact person for scientific queries
Name 1891 0
Professor Ross C Smith
Address 1891 0
Suite 5
Level 5
North Shore Private Hospital
Westbourne Street
St Leonards NSW 2065
Country 1891 0
Australia
Phone 1891 0
02-84253554
Fax 1891 0
Email 1891 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.