None listed
Conditions
Brief summary
Brief description of the study purpose This study is looking at whether intentional weight loss before surgery can be safely achieved in people with obesity who have been diagnosed with resectable gastrointestinal cancer. It will test whether this approach is safe, well tolerated and may help improve outcomes after cancer surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, have resectable gastrointestinal cancer planned for curative treatment, are more than 2 months prior to surgery, and meet the study eligibility criteria for obesity. Study details This study is a randomised controlled trial. Participants will be assigned by chance to receive either tirzepatide (Mounjaro) or a placebo injection once a week before surgery, in addition to their usual cancer care. Participants will attend an initial study visit, monthly review visits while on treatment, a visit before surgery, and follow-up after surgery. They will have measurements taken, be monitored for side effects and progress, and complete questionnaires about their wellbeing and quality of life. Participants will also receive advice from the study team about exercise, nutrition and preparation for surgery. This study is hoped to improve understanding of whether pre-operative weight loss is safe, feasible and beneficial for people preparing for gastrointestinal cancer surgery.
Interventions
Tirzepatide will be administered as a once-weekly subcutaneous injection by the participant or carer, commencing after baseline/randomisation and continuing until 2 weeks prior to surgery. The duration of dosing will vary according to the timing of surgery, with a minimum of 6 weeks of dosing. There is no protocol-defined maximum duration; however, treatment beyond 12 months is not anticipated, and most participants are expected to receive treatment for approximately 3 to 6 months. Tirzepatide w
Tirzepatide will be administered as a once-weekly subcutaneous injection by the participant or carer, commencing after baseline/randomisation and continuing until 2 weeks prior to surgery. The duration of dosing will vary according to the timing of surgery, with a minimum of 6 weeks of dosing. There is no protocol-defined maximum duration; however, treatment beyond 12 months is not anticipated, and most participants are expected to receive treatment for approximately 3 to 6 months. Tirzepatide will be initiated at 2.5 mg once weekly and increased in 2.5 mg increments at 4-week intervals as tolerated, to a maximum dose of 15 mg once weekly. Participants experiencing adverse effects may remain on the current dose for longer, and dose escalation will only occur if tolerated. Adherence will be monitored at monthly study reviews through symptom review, dose-escalation records, and accountability of study medication supply.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Resectable gastrointestinal cancer for curative intent treatment - >2 months prior to surgery - BMI >30 kg/m2
Exclusion criteria
- Six-month weight loss >2% total body weight - Current unintentional decline in weight >1kg/week - Dysphagia to fluids - Active infection - Reliance on feeding tube or oral nutritional supplements - Sarcopaenia (CT measure) - Hypoalbuminaemia
Outcome results
None listed