Ketogenic Diet Phase 1 for Head & Neck Cancer
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of a Ketogenic Diet With Concurrent Chemoradiation for Head and Neck Cancer|
- Frequency of adverse events (safety) [ Time Frame: weekly for 5 weeks ] [ Designated as safety issue: Yes ]Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy.
- Ketone levels [ Time Frame: Daily during treatment for 5 weeks ] [ Designated as safety issue: No ]Quantify blood ketone levels via both finger-stick prior to daily radiation therapy and weekly lab analysis while on a ketogenic diet. Radiation is administered Monday through Friday only.
- Blood glucose levels [ Time Frame: daily during treatment for 5 weeks ] [ Designated as safety issue: Yes ]Quantify blood glucose levels via finger-stick prior to daily radiation therapy while on a ketogenic diet. Radiation therapy is administered Monday through Friday only.
- Oxidative stress parameters [ Time Frame: Weeks 1, 2, 3, 4, and 5 of treatment and at 1 month follow-up ] [ Designated as safety issue: No ]Determine oxidative stress parameters in plasma and urine samples during the course of treatment.
- Progression Free Survival (months) [ Time Frame: Every 12 months for 60 months ] [ Designated as safety issue: Yes ]From date of treatment until the first date of documented progression or date of death, whichever comes first, assessed no less than every 12 months for the first 60 months post-therapy
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||November 2018|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Dietary Supplement: Ketogenic diet
Standard treatment for head & neck cancer often includes chemotherapy concurrent with radiation therapy (chemoradiation).
This study is a phase I trial to determine the safety of dietary manipulation during chemoradiation for head & neck cancer. Specifically, pre-clinical data from mouse studies indicates a ketogenic diet increases tumor cell killing.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01975766
|Contact: Bryan G. Allen, MD, PhD||(319) firstname.lastname@example.org|
|United States, Iowa|
|Holden Comprehensive Cancer Center||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Sandy Vollstedt, RN, BSN, OCN 319-353-7143 email@example.com|
|Contact: Heather Brown, RN, BAN, OCN 319-384-7912 firstname.lastname@example.org|
|Sub-Investigator: Taher Abu Hejleh, MD|
|Principal Investigator: Bryan G. Allen, MD, PhD|
|Sub-Investigator: Carryn M Anderson, MD|
|Sub-Investigator: Rodrigo Bayon, MD|
|Sub-Investigator: Daniel Berg, MD|
|Sub-Investigator: Kellie Bodeker|
|Sub-Investigator: John M. Buatti, MD|
|Sub-Investigator: Kristi Chang, MD|
|Sub-Investigator: Melissa Fath, PhD|
|Sub-Investigator: Gerry Funk, MD|
|Sub-Investigator: Ami Gaarde, BSN|
|Sub-Investigator: Henry Hoffman, MD|
|Sub-Investigator: William Sivitz, MD|
|Sub-Investigator: Brian J Smith, PhD|
|Sub-Investigator: Wenqing Sun, MD, PhD|
|Sub-Investigator: Mindi Tennapel, MBA, MS|
|Sub-Investigator: Sandy Vollstedt, RN, BSN|
|Sub-Investigator: Daniel Vaena, MD|
|Sub-Investigator: Mohammed M Milhem, M.B.B.S|
|Sub-Investigator: Heather Brown, RN, BAN, OCN|
|Sub-Investigator: Kayla Follmer, RDN, LD|
|Principal Investigator:||Bryan G. Allen, MD, PhD||The University of Iowa|