Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00493688
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2007-06-27
Brief Title:
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
Active not recruiting
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:
To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery
In this proposed study researchers will
1 Measure preoperative energy reserve capacity fitness
2 Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism
In this proposed study researchers will
1 Measure preoperative energy reserve capacity fitness
2 Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism
Detailed Description:
Primary Objective
To characterize the effects of neoadjuvant therapy chemotherapy radiation therapy andor immunotherapy on functional capacity in esophageal and lung cancer participants as measured by gas exchange parameters predicted AT predicted P-VO2 VO2 at AT peak exercise oxygen pulse ΔVO2ΔWR ΔVEΔVCO2 obtained from CPET before and after neoadjuvant therapy
Secondary Objectives
To characterize changes in CPET measures in participants treated with chemotherapy radiation therapy andor immunotherapy followed by surgery and correlate these changes with postoperative outcome
To characterize the effects of neoadjuvant therapy chemotherapy radiation therapy andor immunotherapy on functional capacity in esophageal and lung cancer participants as measured by gas exchange parameters predicted AT predicted P-VO2 VO2 at AT peak exercise oxygen pulse ΔVO2ΔWR ΔVEΔVCO2 obtained from CPET before and after neoadjuvant therapy
Secondary Objectives
To characterize changes in CPET measures in participants treated with chemotherapy radiation therapy andor immunotherapy followed by surgery and correlate these changes with postoperative outcome
Study Oversight
Has Oversight DMC:
None
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?:
None