Cancer Nutrition and Exercise rehabilitation program (CaNE) for patients with advanced cancer at risk of cancer cachexia syndrome – a phase II feasibility study

Phase 2

Completed

• Conditions: Patients with advanced upper gastrointestinal cancer; Cancer cachexia syndrome; Patients with advanced lung cancer; Cancer - Stomach; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12615000951550
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-10
• Study Completion: 2018-05-30
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

* 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 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

• Study Type: Interventional
• Study Design: Not specified