A Biological Study of Resveratrol's Effects on Notch-1 Signaling in Subjects With Low Grade Gastrointestinal Tumors

Completed · Not applicable

Conditions studied: Neuroendocrine Tumor

In brief

Resveratrol has been shown to activate a protein called Notch-1. Signaling of Notch-1 has been shown to prevent tumor cell growth. Resveratrol has also been shown to prevent growth of tumors in mice. The purpose of this study is to examine the effects of resveratrol and Notch-1 on neuroendocrine tumor tissue and to examine how people with neuroendocrine tumors who take resveratrol for up to three months tolerate the product.

Key facts

Study ID

NCT01476592

Run by

University of Wisconsin, Madison

People needed

7

Starts

2011-12-01

Expected to finish

2018-10-11

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status of 0-2
• Age >18 years old
• Women who are not postmenopausal must have a negative enrollment blood test and agree to use an effective mode of contraception while taking the study medication
• Greater than four weeks must have elapsed since any previous therapy was administered for the neuroendocrine tumor, including surgery, radiation, chemotherapy or local liver therapy.
• Octreotide use is allowed but must be initiated at least four weeks prior to enrollment and to the pre-treatment biopsy
• Able to give informed consent and willing to undergo the post-treatment research biopsy
• Must be able to take oral medications and be without GI tract obstructive symptoms
• Subjects with another malignancy for which they are either undergoing treatment with chemotherapy or radiation, or with a malignancy for which such treatments have been recommended, would be excluded or withdrawn from the study.
• Must agree to abstain from excessive alcohol, as defined by greater than the equivalent of three glasses of wine per day or one six pack of beer per day

You may not qualify if…

• The principal investigator will review each subject's current medications prior to enrollment of the study to ensure that the administration of Resveratrol will not affect their current medications.

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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