Randomized controlled pilot study to evaluate fasting-mimicking diet in patients receiving chemo-immunotherapy for treatment of metastatic non-small cell lung cancer
Shadia Jalal, MD
Primary Investigator
Overview
Description
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
lung cancer,lung adenocarcinoma
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Age: Between 18 Years - 70 Years
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Gender: All
Inclusion Criteria
Histologically confirmed Lung Adenocarcinoma for which combined chemo-immunotherapy in the form of carboplatin/pemetrexed and pembrolizumab is being utilized. Subjects must have untreated or newly diagnosed metastatic disease. However, they may have received chemotherapy or immunotherapy prior to their enrollment for treatment at an earlier stage.
Radiographically confirmed stage IV metastatic disease
Exclusion Criteria
Self-reported weight loss of more than 10% in 6 weeks prior to informed consent due to malignancy
History of diabetes mellitus or patients with a known recent elevated A1c > 6
History of hypoglycemia
Prior therapies with inhibitors of IGF-1: Linsitinib, Picropodophyllin
6Concurrent use of somatostatin
Concurrent use of post-transplant immunosuppressive medications (sirolimus, tacrolimus, mycophenolate mofetil, azathioprine, prednisone, cyclosporine, etc.)
Significant food allergies which would make the subject unable to consume the food provided
Treatment with any investigational agent within 28 days prior to informed consent
History or current evidence of any medical or psychiatric condition, therapy that may confound the results of the trial, interfere with the subject?s participation for the full duration of the trial, or is not in the best interest of the participating subject as deemed by the treating investigator
