The prognosis for patients with advanced oesophago-gastric cancer is poor. Approximately 16,000 patients in the United Kingdom die from the disease. In spite of new chemotherapy regimens, the average survival for these patients is around 9 months from diagnosis. Omegaven is an infusion comprising omega-3 fish oils. There is evidence that omega-3 fish oil supplementation can improve general well-being and quality of life in patients receiving palliative chemotherapy for a number of different cancer types. It has also been suggested that omega-3 fish oil supplementation may reduce the toxicity of chemotherapy. This clinical trial aims to see whether the addition of Omegaven to EOX chemotherapy, the most widely used regimen for patients with advanced oesophago-gastric cancer, will make this drug regimen more effective at killing oesophago-gastric cancer cells, such that disease progression is delayed. Forty-five patients who have been diagnosed with advanced oesophago-gastric cancer will be recruited over a two year period to receive standard chemotherapy and omega-3 fish oil supplementation. The results in these 45 patients will be compared to a matched historical control group of patients who have received identical chemotherapy. If results suggest that the combination of EOX and Omegaven is sufficiently effective, tolerable and feasible then it will be the intention of the trial team to take the combination forward to treat patients with advanced oesophago-gastric cancer in a randomised study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Weekly omegaven infusion in combination with EOX chemotherapy
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom
Survival
Progression free survival from enrolment to disease progression
Time frame: 12 months
Safety profile
The number of participants requiring dose delays
Time frame: 12 months
Efficacy
Objective response rate as assessed by RECIST v1.1
Time frame: 6 and 12 months
Safety profile
The number of participants experiencing adverse effects
Time frame: 12 months
Safety profile
The number of participants requiring dose modifications
Time frame: 12 months
Safety profile
The number of participants requiring treatment withdrawal due to adverse effects
Time frame: 12 months
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