NCT01716468

Brief Summary

The purpose of this study is to determine the safety and tolerability of a modified low carbohydrate diet, determine if quality of life is improved and to determine if the diet has any effect on tumor growth (size or spread) and or to determine if there is any effect on progression free survival (PFS) and overall survival (OS) of subjects enrolled in the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Oct 2012

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2012

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

May 9, 2016

Completed
Last Updated

May 9, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

September 18, 2012

Results QC Date

February 9, 2016

Last Update Submit

April 9, 2016

Conditions

Cancer

Keywords

Ketogenic Diet, Advanced Cancer, NeoplasmLow carbohydrate

Outcome Measures

Primary Outcomes (1)

  • To Determine the Safety and Tolerability of a Modified Low Carbohydrate Diet in People With Advanced Cancer Across Different Tumor Types.

    Recent studies involving human patients with brain cancer showed tolerability of the Ketogenic diet over a period as long as 19 months with minimal side effects. It is hypothesized that the effect this diet will have on overall weight loss, hyperlipidemia, and blood glucose levels will be minimal and tolerable even by cancer patients over a prolonged period of time, up to 12 months or possibly longer. Serum fasting glucose, cholesterol, total, LDL, HDL and triglycerides, serum ketones in mg/dl units , weight in lbs. will be measured at designated time points. Number of patients actually tolerating the diet for at least 4 weeks or more will be recorded.

    16 weeks

Study Arms (1)

Advanced or metastatic cancer

OTHER

Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).All participants will be assigned to a ketogenic diet. There are no randomization to other separate arms since this is a safety and feasibility study.

Other: Ketogenic Diet

Interventions

Ketogenic DietOTHER

modified ketogenic diet

Advanced or metastatic cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Prisoners or subjects who are involuntarily incarcerated.
  • Secondary brain metastases.
  • History of Gout.
  • AST or ATL \> 1.5 X ULN.
  • Creatinine \> 2.0.
  • Hematologic malignancies
  • BMI \< 22.
  • History of kidney disease or kidney stones.
  • Receiving chemotherapy including biologics.
  • Recent AMI/TIA or stroke within one month of study entry.
  • ECOG performance status of 3 or worse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (1)

  • Tan-Shalaby JL, Carrick J, Edinger K, Genovese D, Liman AD, Passero VA, Shah RB. Modified Atkins diet in advanced malignancies - final results of a safety and feasibility trial within the Veterans Affairs Pittsburgh Healthcare System. Nutr Metab (Lond). 2016 Aug 12;13:52. doi: 10.1186/s12986-016-0113-y. eCollection 2016.

    PMID: 27525031DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Results Point of Contact

Title
Jocelyn Tan, MD
Organization
VA Pittsburgh Healthcare System
Jocelyn.Tan@va.gov
412-360-6178

Study Officials

  • Jocelyn Tan, MD

    VA Pittsburgh Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician-Hematology/Oncology

Study Record Dates

First Submitted

September 18, 2012

First Posted

October 29, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

May 9, 2016

Results First Posted

May 9, 2016

Record last verified: 2016-04

Locations

US(1)