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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01419483
Other study ID # 201102772
Secondary ID 1R21CA161182
Status Terminated
Phase N/A
First received July 28, 2011
Last updated January 4, 2018
Start date July 2011
Est. completion date July 2017

Study information

Verified date January 2018
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Ketogenic diet
A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.

Locations

Country Name City State
United States Holden Comprehensive Cancer Center Iowa City Iowa

Sponsors (4)

Lead Sponsor Collaborator
University of Iowa National Cancer Institute (NCI), National Institutes of Health (NIH), Nutricia North America

Country where clinical trial is conducted

United States, 

References & Publications (1)

Zahra A, Fath MA, Opat E, Mapuskar KA, Bhatia SK, Ma DC, Rodman SN III, Snyders TP, Chenard CA, Eichenberger-Gilmore JM, Bodeker KL, Ahmann L, Smith BJ, Vollstedt SA, Brown HA, Hejleh TA, Clamon GH, Berg DJ, Szweda LI, Spitz DR, Buatti JM, Allen BG. Consu — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of Adverse Events (Safety) Categorize and quantify adverse events in subjects implementing a ketogenic diet while undergoing definitive chemoradiation therapy. Weekly for 8 weeks
Secondary Ketone levels 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. Daily during treatment for 6 weeks
Secondary Blood glucose levels 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. Daily during treatment for 6 weeks
Secondary Oxidative stress parameters Determine oxidative stress parameters in plasma and urine samples during the course of treatment. Weeks 1, 2, 3, 4, 5, and 6 of treatment and at 1 month follow-up
Secondary Progression Free Survival (months) 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. Every 12 months for 60 months
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