Please be advised that due to the high volume of submissions, the ANZCTR is currently experiencing delays in processing submissions from those outside of Australia and New Zealand. As the ANZCTR is funded by Australia and New Zealand, we must prioritise submissions from these countries first. International submissions should allow additional time for registration. Apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000951550
Ethics application status
Approved
Date submitted
31/08/2015
Date registered
10/09/2015
Date last updated
10/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Cancer Nutrition and Exercise rehabilitation program (CaNE) for patients with advanced cancer at risk of cancer cachexia syndrome – a phase II feasibility study
Scientific title
A feasibility study looking at the effect of an exercise, fish oil and nutrition supplement intervention program versus standard of care for patients with advanced cancer who are at risk of cancer cachexia syndrome
Secondary ID [1] 287348 0
Nil
Universal Trial Number (UTN)
U1111-1173-2940
Trial acronym
CaNE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with advanced upper gastrointestinal cancer 296009 0
Cancer cachexia syndrome 296010 0
Patients with advanced lung cancer 296011 0
Condition category
Condition code
Cancer 296289 296289 0 0
Stomach
Physical Medicine / Rehabilitation 296290 296290 0 0
Other physical medicine / rehabilitation
Diet and Nutrition 296291 296291 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study intervention arm is a combined exercise and nutritional program. It comprises a 12-week physical activity (PA) program of two supervised, tailored 60-minute strength-based exercise sessions in group format per week, a standardised oral nutritional supplement high in protein (Resource Protein, 200ml bottle, which contains 18.8g protein per bottle) immediately following each exercise session (twice weekly), and high-strength fish oil supplements on a daily basis (2g of EPA/day)]. The exercise session will be supervised by an accredited Exercise Physiologist.
Log of exercise attendance, exercise log, visual inspection of oral nutritional supplement consumption and capsule counting to monitor adherence.
Intervention code [1] 292686 0
Treatment: Other
Intervention code [2] 292688 0
Prevention
Intervention code [3] 292772 0
Treatment: Drugs
Comparator / control treatment
Exercise, oral supplement and fish oil intervention arm versus standard treatment arm

Standard treatment arm receive usual care (which may or may not include anti-cancer treatment) as provided by their treating oncologist and team.

During the study period, if participant(s) from either arm are deemed to be malnourished by their treating team, they may be reviewed by a dietitian and receive additional oral nutritional supplements as part of standard care. Use of additional oral nutritional supplements will be documented.
Control group
Active

Outcomes
Primary outcome [1] 295942 0
Feasibility of attending twice a week 1-hr resistance exercise training for 12 weeks. Attendance is measured by review of exercise session registers kept by the exercise physiologist.
Timepoint [1] 295942 0
At completion of 12-weeks study intervention
Primary outcome [2] 295943 0
Adherence to oral nutritional supplement after exercise session. This is assessed by review of nutritional supplement log which is kept by exercise physiologist or research assistant who physically supervise taking of nutritional supplement post exercise.
Timepoint [2] 295943 0
At completion of 12-weeks study intervention
Primary outcome [3] 295944 0
Adherence to fish oil supplementation (2g/d) for the duration of 12 weeks.
This is assessed by review of fish oil logs and counting of capsules.
Timepoint [3] 295944 0
At completion of 12-weeks study intervention
Secondary outcome [1] 316985 0
Body composition will be assessed using bioimpedance analysis method, anthropometric and skinfold measurements
Timepoint [1] 316985 0
At 12 weeks, and 6 months after randomisation
Secondary outcome [2] 316986 0
Nutritional status will be assessed using a 3-day food diary and a validated nutritional assessment tool, The Patient-Generated Subjective Global Assessment
Timepoint [2] 316986 0
At 12 weeks and 6 months after randomisation
Secondary outcome [3] 316987 0
Functional status will be assessed using handgrip strength, sit to stand and a 6-min walk test and clinician rated-ECOG performance status
Timepoint [3] 316987 0
At 12 weeks and 6 months after randomisation
Secondary outcome [4] 316988 0
Muscular strength will be assessed using 10RM test which include leg press, chest press and seated row

Timepoint [4] 316988 0
At 12 weeks, and 6 months after randomisation
Secondary outcome [5] 316989 0
Quality of life will be assessed using FACT-G, FACIT-fatigue subscale and FAACT – anorexia subscale questionnaires

Timepoint [5] 316989 0
At 6 and12 weeks, and 6 months after randomisation
Secondary outcome [6] 316990 0
Distress level will be assessed using a single item distress thermometer

Timepoint [6] 316990 0
At 6 and 12 weeks, and 6 months after randomisation
Secondary outcome [7] 316991 0
Symptoms experienced will be assessed using Patient’s Disease and Treatment assessment form

Timepoint [7] 316991 0
At 6 and 12 weeks, and 6 months after randomisation
Secondary outcome [8] 316992 0
Tolerance to chemotherapy including toxicities, and adverse events will be assessed against National Cancer Institute Common Terminology Criteria for Adverse Events version 4 (only applicable to participants who are still on anti-cancer treatment)

Timepoint [8] 316992 0
At 6 and 12 weeks, and 6 months after randomisation

Eligibility
Key inclusion criteria
* Aged at least 18 years;
* Histologically confirmed advanced incurable upper gastrointestinal UGI) cancer (including gastric, pancreatic, biliary), or lung cancer;
* Have a BMI of 20kg/m2 and above (*BMI of <20kg/m2 will only be included if baseline BMI pre-diagnosis was consistently <20kg/m2)
* Have medical clearance for exercise and willing to attend supervised exercise sessions twice per week and consume high protein oral nutritional supplement (200ml) and daily fish oil supplementation;
* ECOG performance status of 0-1;
* Able (i.e. sufficiently fluent) to follow instructions in English;
* Willing to complete the patient-reported outcome questionnaires, exercise logs and food diary in English; and,
* Agreeable to follow up for 6 months or till death whichever occurs first
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Life expectancy of <6 months;
- Weight loss of >10% in the previous month, or ongoing weight loss of >3kg over the previous 3 months;
- Already doing resistance-training >2 hours per week;
- Unable to do strength-based exercise for physical or medical reasons;
- Unable to give informed consent or follow instructions in English;
- Currently taking fish oil supplement (540mg EPA or more), and unwilling to stop for the duration of the study;
- Allergic to fish oil or unable to take fish oil capsules;
- Unable to tolerate high protein supplements;
- Major surgery within the last 8 weeks;
- Unresolved gastrointestinal tract (GIT) obstruction (ie. gastric outlet obstruction, bowel obstruction);
- Symptomatic brain metastases;
- Concurrent corticosteroids or progestogens (corticosteroids used in the short-term for anti-emetics purposes are allowed). Patients needing to be commenced on corticosteroids for a clinical indication during the study (e.g. symptomatic brain metastases, spinal cord compression, intractable vomiting) will be withdrawn and no subsequent assessments undertaken;
- Concurrent androgens, cannabinoids, olanzapine or other psychostimulants (antidepressants or anti-psychotics) prescribed for appetite stimulation; and
- Tube feeding or parenteral nutrition

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pre-randomisation evaluation focuses on patients eligibility for the study. Once they are deemed eligible they will be required to give written informed consent. Baseline assessments will then be completed prior to randomisation. Randomisation will be on a 2:1 in favour of the intervention and will be set-up by the study’s biostatistician. Randomisation of participants will be managed by research staff independent of the study, they will be contacted via telephone to randomise the patient and provide treatment allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by a computerised random number generator and provided to the randomisation service by the study biostatistician.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Tri-modalities intervention
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4278 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 10226 0
2139 - Concord Repatriation Hospital

Funding & Sponsors
Funding source category [1] 291945 0
University
Name [1] 291945 0
Sydney Catalyst, University of Sydney
Address [1] 291945 0
Sydney Catalyst Central Office
Chris O'Brien Lifehouse Building
Level 6, 119-143 Missenden Rd, Camperdown NSW 2050
Country [1] 291945 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Sydney Catalyst Central Office
Chris O'Brien Lifehouse Building
Level 6, 119-143 Missenden Rd, Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 290614 0
None
Name [1] 290614 0
Address [1] 290614 0
Country [1] 290614 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293442 0
Sydney Local Health District Human Research Ethics Committee -CRGH
Ethics committee address [1] 293442 0
Sydney Local Health District Human Research Ethics Committee –CRGH
Concord Repatriation General Hospital (CRGH)
Hospital Rd
Concord NSW 2139
Ethics committee country [1] 293442 0
Australia
Date submitted for ethics approval [1] 293442 0
26/05/2015
Approval date [1] 293442 0
18/08/2015
Ethics approval number [1] 293442 0
HREC/15/CRGH/109

Summary
Brief summary
The primary purpose of this study is to evaluate the feasibility of delivering a combined nutritional and exercise intervention in patients with inoperable gastrointestinal (GI) or lung cancer, who are at risk of developing cancer cachexia. The ultimate aim is to determine whether the combined intervention prevents or slows progression of cancer cachexia, and improves performance status, nutritional status, and quality of life. Who is it for? You may be eligible to join this study if you are aged 18 or over, have advanced incurable upper gastrointestinal cancer (including gastric, pancreatic, biliary), or lung cancer, and a BMI of 20 or higher. Study details Participants in this study will be randomly chosen (by chance) to receive either standard treatment or the nutrition and exercise intervention program. The program involves completing two supervised 1 hour strength-based exercise sessions per week, taking a high protein nutritional supplement drink after each exercise session and taking daily fish oil supplement tablets. The program will last for 12 weeks. Outcomes will be measured at 6 weeks and 12 weeks into the program, and at 6 months. Participants will complete a number of questionnaires, will be asked to keep a 3-day food diary and complete strength and walking tests. It is hoped that the findings of this study will provide information on the efficacy and feasibility of the nutrition and exercise intervention in cancer patients, with the hope that it will slow or prevent the development of cachexia in these individuals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59838 0
A/Prof Janette Vardy
Address 59838 0
Concord Cancer Centre, Concord Repatriation & General Hospital
Hospital Rd, Concord, NSW, 2139 Australia


Country 59838 0
Australia
Phone 59838 0
Tel: +612 9767 5000
Fax 59838 0
Fax:+612 97675764
Email 59838 0
janette.vardy@sydney.edu.au
Contact person for public queries
Name 59839 0
A/Prof Janette Vardy
Address 59839 0
Concord Cancer Centre, Concord Repatriation & General Hospital
Hospital Rd, Concord, NSW, 2139 Australia

Country 59839 0
Australia
Phone 59839 0
Tel: +612 9767 5000
Fax 59839 0
Fax:+612 97675764
Email 59839 0
janette.vardy@sydney.edu.au
Contact person for scientific queries
Name 59840 0
A/Prof Janette Vardy
Address 59840 0
Concord Cancer Centre, Concord Repatriation & General Hospital
Hospital Rd, Concord, NSW, 2139 Australia

Country 59840 0
Australia
Phone 59840 0
Tel: +612 9767 5000
Fax 59840 0
Fax:+612 97675764
Email 59840 0
janette.vardy@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results