Feasibility Trial of the Modified Atkins Diet and Bevacizumab for Recurrent Glioblastoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT02768389
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Subjects receive Bevacizumab as standard of care
  • Modified Atkins Diet — BEHAVIORAL
    The modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (\< 20gm/day).

Study Details

Patients may participate in this research study if they have glioblastoma. (a brain tumor) that has come back after being treated. Standard treatment for this cancer is a chemotherapy drug called bevacizumab. This research study involves bevacizumab in combination with a special diet called the Modified Atkins Diet (MAD). The purpose of this study is to research if patients can stay on the MAD when it is added to the standard bevacizumab treatment.

Key Dates

First listed
May 11, 2016
Start date
Sep 6, 2016
Status verified
Mar 2019
Primary completion
Nov 30, 2018
Completion
Nov 30, 2018

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Modified Atkins Diet and Bevacizumab
    Patients and caregivers will be educated by a nutritionist skilled in the MAD. Patients will also be receiving Bevacizumab as standard of care.

Primary Outcome Measure

Number of subjects following Modified Atkins Diet [ Time Frame: Up to 12 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45220-
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive cancer CenterClevelandOhio44195-
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-
OhioHealth Research and Innovation InstituteColumbusOhio43214-

Find similar trials in Cincinnati, OH

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of Cincinnati· Cincinnati, OHCleveland Clinic Taussig Cancer Institute, Case Comprehensive cancer Center· Cleveland, OHUniversity Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OHOhioHealth Research and Innovation Institute· Columbus, OH

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