|Phase I||Biomarker/Laboratory analysis, Treatment||Active||18 and over||NCI, Other||201102772|
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.
Further Study Information
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.
- 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
- Patients must have a cytological or histological diagnosis of adenocarcinoma arising in the pancreas. Adenosquamous cancers will be acceptable.
- Cancer should be staged via AJCC as IIA, IIB, or III (T3 or T4, any N, M0)
- Age ≥ 18 years
- ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).
- Hypertensive medication should be initiated or increased for optimal blood pressure control according to standard public health guidelines prior to starting the ketogenic diet.
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥ 3,000/mm3
- absolute neutrophil count ≥ 1,500/mm3
- platelets ≥ 100,000/mm3
- total bilirubin < 3.0 mg/dl
- Hgb A1C < or = to 8%
- AST(SGOT) < or = 5 X institutional upper limit of normal OR a stable or a decreasing test value in patients who have undergone placement of an intrabiliary stent. Both the treating radiation oncologist and medical oncologist must agree that the potential subject's test value is acceptable for study accrual.
- creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
- Not pregnant. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document.
- Prior abdominal radiotherapy.
- Prior therapy, with the intent to treat, the current diagnosis of pancreatic cancer.
- Known G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- Patients on corticosteroids for any reason.
- Living alone at time of diet initiation.
- Other investigational agents/therapy with the intention to treat the disease under study (observational or imaging trials are acceptable).
- Uncontrolled diabetes defined as a hemoglobin A1C level > 8% (therapeutic action is indicated at greater than 8%).
- Diabetes mellitus is not exclusionary provided the patient is not maintained with either oral medications or insulin.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric illness/social situations, or any other condition that would limit compliance with study requirements as determined by study team members.
- Pregnant or lactating women: The risks of radiation and chemotherapy to a fetus are well documented.
Female and male patients of all ethnic groups will be eligible for treatment in these protocols.
Trial Lead Organizations/Sponsors
Holden Comprehensive Cancer Center at University of IowaNational Cancer Institute
National Cancer Institute
Nutricia North America
Holden Comprehensive Cancer Center at University of Iowa
|Sudershan K Bhatia, MD, MPH, PhD||Principal Investigator|
|Jane Hershberger, RN, BSN||Ph: (319) 384-7912|
|Holden Comprehensive Cancer Center at University of Iowa|
|Jane Hershberger, RN, BSN||Ph: 319-384-7912|
|Sandy Vollstedt, RN, BSN||Ph: (319) 353 7143|
|Sudershan k Bhatia, MD, MPH, PhD||Principal Investigator|
|Daniel James Berg||Principal Investigator|
|John Michael Buatti||Principal Investigator|
|Douglas Spitz, PhD||Principal Investigator|
|Bryan Allen, MD, PhD||Sub-Investigator|
|Melissa Fath, PhD||Sub-Investigator|
|William Sivitz, MD||Sub-Investigator|
|Margaret Bayless, CDE CCRC RN||Sub-Investigator|
|Cathy Chenard, MS, RD, LD||Sub-Investigator|
|James R Howe||Sub-Investigator|
|Hisakazu Hoshi, MD||Sub-Investigator|
|Joseph J Cullen, MD||Sub-Investigator|
|Robert J Robinson, MD||Sub-Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01419483
Information obtained from ClinicalTrials.gov on November 20, 2012
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