Abdominal CancerNCT00493688
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
An observational study of Abdominal Cancer and Pelvic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer, Pelvic Cancer
- What is being tested?
- Cardiopulmonary Exercise Testing (CPET)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2005to 30 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
MD Anderson General Health Specialist, 877-632-6789
About this study
To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery.
In this proposed study researchers will:
- Measure preoperative energy reserve capacity (fitness)
- Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism
Read the detailed description
Primary Objective:
- To characterize the effects of neoadjuvant therapy (chemotherapy, radiation therapy, and/or 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, ΔVO2/ΔWR, ΔVE/ΔVCO2) obtained from CPET before and after neoadjuvant therapy.
Secondary Objectives:
- To characterize changes in CPET measures in participants treated with chemotherapy, radiation therapy, and/or immunotherapy followed by surgery and correlate these changes with postoperative outcome.
- Conditions
- Abdominal Cancer, Pelvic Cancer
- Being tested
- Cardiopulmonary Exercise Testing (CPET)
- Keywords
- Abdominal Cancer, Pelvic Cancer, Perioperative Energy Dynamics, Cardiopulmonary Exercise Testing, CPET
- Medical subject headings
- Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary Exercise Testing (CPET)Other
Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases.
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary Exercise Testing (CPET) | Not described Receives: Other: Cardiopulmonary Exercise Testing (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline + 30 days postoperatively monitoring for morbid events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study start30 Oct 2005
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anh Dang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493688
- Sponsor's protocol ID
- 2005-0303
- Other IDs
- NCI-2024-06349
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2007
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT00493688
- Acronym / sponsor ID
- 2005-0303
- Conditions
- Abdominal Cancer, Pelvic Cancer
- Keywords
- Abdominal Cancer, Pelvic Cancer, Perioperative Energy Dynamics, Cardiopulmonary Exercise Testing, CPET
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 30 Oct 2005 (actual)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 28 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery.
In this proposed study researchers will:
- Measure preoperative energy reserve capacity (fitness)
- 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, and/or 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, ΔVO2/ΔWR, ΔVE/ΔVCO2) obtained from CPET before and after neoadjuvant therapy.
Secondary Objectives:
- To characterize changes in CPET measures in participants treated with chemotherapy, radiation therapy, and/or immunotherapy followed by surgery and correlate these changes with postoperative outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary Exercise Testing (CPET) | – | Other: Cardiopulmonary Exercise Testing (CPET) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary Exercise Testing (CPET)Pedaling on a Stationary Bicycle at 60 Revolutions Per Minute as the Resistance to Pedaling Gradually Increases. | Other | Cardiopulmonary Exercise Testing (CPET) |
Primary outcome
Patient Perioperative Risk
Time frame: Baseline + 30 days postoperatively monitoring for morbid events
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anh Dang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Cancer and Pelvic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anh Q Dang, MD (713-745-5025, adang@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Perioperative Risk (time frame: Baseline + 30 days postoperatively monitoring for morbid events). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.