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Trial record 11 of 55 for:    cancer AND energy restriction

Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC) (METRO)

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ClinicalTrials.gov Identifier: NCT02019979
Recruitment Status : Terminated (PI left the institution)
First Posted : December 24, 2013
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
Beth Israel Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Non-small Cell Lung Cancer Stage IIIB/IV
Non-small Cell Lung Cancer Metastatic
Nonsquamous Nonsmall Cell Neoplasm of Lung
Interventions Drug: metformin
Behavioral: carbohydrate restricted diet
Enrollment 14
Recruitment Details Recruitment began in December 2013 with enrollment from Jan 2014 to April 2016 at 3 sites. 17 initially enrolled, but 3 came off study prior to beginning therapy and not included in analysis.
Pre-assignment Details  
Arm/Group Title Metformin /Carbohydrate Restricted Diet
Hide Arm/Group Description

metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen

metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy

Period Title: Overall Study
Started 14
Completed 0
Not Completed 14
Reason Not Completed
study terminated             14
Arm/Group Title Metformin /Carbohydrate Restricted Diet
Hide Arm/Group Description

metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen

metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants
66.71  (6.24)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
8
  57.1%
Male
6
  42.9%
1.Primary Outcome
Title Progress Free Survival
Hide Description Progress Free Survival (PFS) is defined as the time from the date of the first dose of treatment to the earlier of the dates of first disease progression per RECIST 1.1 or death from any cause.
Time Frame Time after day 1 cycle 1 to first disease progression for up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin /Carbohydrate Restricted Diet
Hide Arm/Group Description:

metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen

metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy

Overall Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: months
3.9
(.33 to 16.17)
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) is defined as time from date of first dose to date of death from any cause.
Time Frame up to 30 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin /Carbohydrate Restricted Diet
Hide Arm/Group Description:

metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen

metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy

Overall Number of Participants Analyzed 14
Mean (Full Range)
Unit of Measure: months
11.7
(0.33 to 28.90)
3.Secondary Outcome
Title Number of Participants With LKBI Mutation
Hide Description To evaluate LKBI mutations as a potential bio-marker to predict subjects who will benefit most from metformin in combination with a carbohydrate restricted diet
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Metformin /Carbohydrate Restricted Diet
Hide Arm/Group Description:

metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen

metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy

Overall Number of Participants Analyzed 14
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metformin /Carbohydrate Restricted Diet
Hide Arm/Group Description

metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen

metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy

carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy

All-Cause Mortality
Metformin /Carbohydrate Restricted Diet
Affected / at Risk (%)
Total   0/14 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Metformin /Carbohydrate Restricted Diet
Affected / at Risk (%) # Events
Total   1/14 (7.14%)    
Gastrointestinal disorders   
Reflux  1/14 (7.14%)  1
General disorders   
Nausea  1/14 (7.14%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Metformin /Carbohydrate Restricted Diet
Affected / at Risk (%) # Events
Total   1/14 (7.14%)    
Blood and lymphatic system disorders   
Anemia  1/14 (7.14%)  4
Leukopenia  1/14 (7.14%)  3
General disorders   
Fatigue  1/14 (7.14%)  6
Nausea  1/14 (7.14%)  4
Metabolism and nutrition disorders   
Hypoalbuminemia  1/14 (7.14%)  3
Early termination of study because PI left institution. Not all study visits completed leading to incomplete data.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Anish Parikh
Organization: Icahn School of Medicine at Mount Sinai
Phone: (212) 241-4705
Responsible Party: Beth Israel Medical Center
ClinicalTrials.gov Identifier: NCT02019979     History of Changes
Obsolete Identifiers: NCT02254512
Other Study ID Numbers: METRO 090-13
First Submitted: December 13, 2013
First Posted: December 24, 2013
Results First Submitted: March 6, 2018
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018