Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-30 @ 11:50 AM
Study NCT ID:
NCT02887235
Status:
COMPLETED
Last Update Posted:
2020-06-09
First Post:
2016-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food as Medicine: An RCT to Study the Effect of Home Delivered, Medically Tailored Meals on Patients With Metastatic Cancer
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Food as Medicine: A Phase III Randomized Controlled Trial of Home Delivered, Medically Tailored Meals (HDMTM) on Quality of Life in Metastatic Lung and Non-colorectal GI Cancer Patients
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether medically tailored meals (HDTM) can improve quality of life for patients with metastatic cancer.
Detailed Description:
The current standard of care at the cancer center is for all patients receiving cytotoxic therapy to undergo a nutritional consultation and evaluation with a registered oncology dietitian. The goal of this consultation is to prevent nutritional deficiencies, promote optimal nutritional intake, hydration, and weight maintenance, as well as maintain lean body mass.
All patients on this study will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. However, patients randomized to arm 2 will receive home delivered, medically tailored meals in addition to the standard nutritional care.
All patients on this study will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. However, patients randomized to arm 2 will receive home delivered, medically tailored meals in addition to the standard nutritional care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: