Cancer Nutrition and Exercise rehabilitation program (CaNE) for patients with advanced cancer at risk of cancer cachexia syndrome – a phase II feasibility study
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
The University of Sydney
28 participants
Nov 19, 2015
Interventional
Conditions
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.
Eligibility
Inclusion Criteria8
- Aged at least 18 years;
- Histologically confirmed advanced incurable UGI cancer (including gastric, pancreatic, biliary), or lung cancer, or biopsy PROVEN malignancy of unknown origin but where clinical, imaging and biomarkers strongly suggest it to be an UGI or lung primary;
- 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
Exclusion Criteria14
- 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
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Interventions
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.
Locations(1)
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ACTRN12615000951550