Clinical trialNATerminated
Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer
A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Pancreatic Cancer.
- Outcome
- Stopped earlypoor accrual (Enrollment)
- Phase
- NA
- Status
- Terminated
- Study type
- Interventional
- Start
- July 2011
- Expected end
- July 2017
- Enrollment
- 5 participants
- Sites
- 1
- Primary outcomes
- Frequency of Adverse Events (Safety)
- Sponsor
- Other
- Results posted
- No
- Last update
- 8 January 2018
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Brief summary public domain (ClinicalTrials.gov)
This study investigates if using a very low carbohydrate diet during combined chemotherapy and radiation therapy is safe and if it can be tolerated by patients.
Detailed description public domain (ClinicalTrials.gov)
Standard treatment for pancreatic cancer includes chemotherapy concurrent with radiation therapy (chemoradiation). This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for pancreatic cancer. Specifically, pre-clinical data from mouse studies indicates a ketogenic diet increases tumor cell killing. Participants will: * Utilize a specialized ketogenic diet designed by bionutritional services of the clinical research unit. This diet begins 2 days before chemoradiation and continues through at least 5 weeks of chemoradiation. * Have blood drawn for research purposes weekly to determine measurements of oxidative stress * Have urine collected sporadically through the study to determine measurements of oxidative stress * Keep a diary of concomitant medications, side effects, and blood sugars * Have follow-up to monitor for outcomes and overall survival
Papers 1
- Registry-listed results paperConsuming a Ketogenic Diet while Receiving Radiation and Chemotherapy for Locally Advanced Lung Cancer and Pancreatic C… DOI 10.1667/rr14668.1↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.