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Spots Global Cancer Trial Database for Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer

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Trial Identification

Brief Title: Study of Additive Omega-3 Fish Oil to Palliative Chemotherapy to Treat Oesophagogastric Cancer

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

Study ID: NCT01870791

Interventions

Omegaven

Study Description

Brief Summary: 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University Hospitals of Leicester NHS Trust, Leicester, Leicestershire, United Kingdom

Contact Details

Name: David J Bowrey, MD

Affiliation: University Hospitals, Leicester

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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