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Title:
The feasibility and biologic effect of a modified Atkins-based intermittent fasting diet in patients with high-grade astrocytoma
Protocol Number:
J1444
Phase:
Phase I
Physician:
Jaishri Blakeley
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
To determine if a modified Atkins diet with intermittent fasting is possible and safe in patients with malignant gliomas who have completed radiation and chemotherapy for newly diagnosed tumors.
Eligibility:
Patients with newly diagnosed malignant gliomas (anaplastic astrocytoma, anaplastic oligodendroglioma & glioblastoma multiforme) who have completed standard radiation with temozolomide AND adjuvant temozolomide.* Must be at least 7 months from the time of completing radiation * Must have completed 80% of prescribed radiation and temozolomide without significant lowered blood counts at any time point during therapy (low white blood cell count less than 2.0 K/cu mm or low platelet count less than 50,000 K/cu mm) * Must have a body mass index (BMI) greater than 20 * Must be eligible to undergo a ketogenic or Atkins based diet as determined by any other present medical conditions and baseline laboratory studies. * May NOT have milk allergy * May NOT have had treatment with a modified Atkins diet for any cause within 9 months prior to trial participation. * May NOT be on another clinical trial at the same time
Treatment:
Patients participate in an 8-week course of a closely monitored modified Atkins diet with 2 days of fasting each week (supplied nutritional drink allowed on fasting days). Patients undergo a MRI Brain (Spectroscopy) prior to the start of the diet and at the conclusion of the 8 week diet. Visits occur every 2 weeks over the course of the 8-week study and include a screening visit and baseline visit prior to the start of the diet. In total, there are 6 study visit. Laboratory blood and urine studies and collected at study visit time points. A Registered Dietician (RD) & Licensed Dietician/Nutritionist (LDN who specializes in the modified Atkins closely monitors and counsels each patient's course in conjunction with a neuro-oncology provider.
Population:
Adult
Last Update
03/05/2019 05:03 AM