NCT00493688

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. 1.Measure preoperative energy reserve capacity (fitness)
  2. 2.Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
30mo left

Started Oct 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress89%
Oct 2005Oct 2028

Study Start

First participant enrolled

October 30, 2005

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 28, 2007

Completed
21.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2028

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

23 years

First QC Date

June 27, 2007

Last Update Submit

January 6, 2026

Conditions

Abdominal CancerPelvic Cancer

Keywords

Abdominal CancerPelvic CancerPerioperative Energy DynamicsCardiopulmonary Exercise TestingCPET

Outcome Measures

Primary Outcomes (1)

  • Patient Perioperative Risk

    Measure preoperative energy reserve capacity (fitness) using perioperative energy dynamics where fitness is defined by gas exchange data during cardiopulmonary exercise testing as method of assessing perioperative risk

    Baseline + 30 days postoperatively monitoring for morbid events

Study Arms (1)

Cardiopulmonary Exercise Testing (CPET)

Other: Cardiopulmonary Exercise Testing (CPET)

Interventions

Cardiopulmonary Exercise Testing (CPET)OTHER

Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.

Cardiopulmonary Exercise Testing (CPET)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals scheduled for elective major intrabdominal surgery or pelvic surgeries surgeries (e.g. gastrectomy, esophagectomy, pancreatectomy, radical cystectomy, radical transabdominal debulking with or without intrabdominal hyperthermic perfusion, pelvic exenteration, retroperitoneal lymph node dissections, and low anterior resection).

You may qualify if:

  • Participants 18 years of age or older.
  • Participants with newly diagnosed esophageal and lung cancer undergoing neoadjuvant chemotherapy, radiation therapy, and/or immunotherapy.
  • Participants who have signed the consent form to participate in the study.
  • Participants must have been evaluated in the Perioperative Evaluation and Management (POEM) Center or by a staff Anesthesiologist.
  • All laboratory and diagnostic evaluations required or used to evaluate the patient must be completed. All participants must be approved to undergo anesthesia by the standards of the POEM Center.
  • No samples belonging to vulnerable populations (children, pregnant women, cognitively impaired adults or prisoners) will be allowed from participation.

You may not qualify if:

  • Participant is under age 18.
  • Participant is unwilling to sign consent.
  • Participant is unable to exercise (bedridden or wheel chair bound).
  • Participant is enrolled in another study deemed by the investigator to affect oxygen metabolic efficiency and not presently the standard of care at MDACC.
  • Participant's condition is deemed unsatisfactory for surgery after the preanesthetic evaluation.
  • Participant has had a myocardial infarction within three months of the preanesthetic evaluation or presents with new or unstable angina.
  • Participant has a history of a cerebrovascular accident or transit ischemic attacks within three months of the preanesthetic evaluation.
  • Participant has a history of a pulmonary embolic event within three months of the preanesthetic evaluation.
  • Participant is known to have acute or chronic deep vein thrombosis.
  • Participant is pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Pelvic Neoplasms

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Anh Dang, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anh Q Dang, MD

CONTACT

713-745-5025adang@mdanderson.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2007

First Posted

June 28, 2007

Study Start

October 30, 2005

Primary Completion (Estimated)

October 30, 2028

Study Completion (Estimated)

October 30, 2028

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations

US(1)