Gastric Neoplasm Clinical Trial
Official title:
Phase II Trial of Palliative Epirubicin, Oxaliplatin & Capecitabine (EOX) Chemotherapy Combined With Omega-3 Fish Oil Infusion (Omegaven) in Patients With Oesophagogastric Carcinoma
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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