Stomach NeoplasmsNCT03423056
Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.
A study testing Preoperative exercise program in people with Stomach Neoplasms and Colonic Neoplasms, run by Instituto Nacional de Cancerologia, Columbia at 1 site in Colombia.
Trial summary
Patients with gastrointestinal cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal surgical procedures. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms
- What is being tested?
- Preoperative exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- 1 Apr 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45 to 70 years
- Confirmed diagnosis of gastric, hepatic, colon or rectal cancer.
- Live in Bogota for at least 3 months
- Hemoglobin concentration superior to 10g/dL
- Primary surgery date scheduled in the next 4 weeks or more since eligibility assessment
- ECOG score 0 or 1
Who cannot join
- Behavior or cognitive impairment
- musculoskeletal impairment
- any exercise contraindication (fracture or sprains in the last 2 months, severe osteoarthritis, tendinitis)
- Uncontrolled metabolically comorbidities (diabetes, hypertension, hyperlipidemia)
- Presence of obstructive or restrictive pulmonary disease
- Enrolled in another supervised exercise program
- Major electrocardiographic abnormalities.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Instituto Nacional de Cancerología
Bogota, Cundinamarca, 0000
Maria T. Vallejo, Md, +5714320160 ext. 5973, mvallejo@cancer.gov.co
About this study
Official title: Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer. A Phase II Clinical Trial
Patients with gastrointestinal cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal surgical procedures.
It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.
Read more
Main objective:
To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.
Materials and methods:
This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, hepatic, colon or rectal cancer), without electrocardiographic abnormalities, and scheduled for primary surgery in 4 weeks or more since recruitment
All the enrolled patients will receive a basal aerobic capacity assessment with the 6-minute walk test. Then, two physical therapist will prescribe them a supervised and individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will increase the heart rate target weekly (from 50% to 70% of the maximum heart rate). The aerobic exercise will be carried on a treadmill or in a stationary bicycle.
The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence.
This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board
Read the detailed description
Gastrointestinal - origin cancer is one of the most frequent causes of cancer worldwide ; the primary surgical management is the standard treatment, however, the postoperative complications rate could be up to 35% . Patients with gastrointestinal - origin cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal procedures.
It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.
Main objective:
To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.
Materials and methods:
This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, liver, colon or rectal cancer), scheduled for surgery in 4 weeks or more since recruitment and without electrocardiographic abnormalities.
The patients will be selected from the gastrointestinal unit surgical schedule. The eligible patients will be invited to participate and after their agreement to participate and to do the informed consent process, they will be scheduled to the basal assessment. This aerobic capacity assessment will be done with the 6-minute walk test.
After the basal measurement, two physical therapists will prescribe an individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will be programmed as follows:
- Week 1: heart rate target: 50% of maximum heart rate
- Week 2: heart rate target: 60% of maximum heart rate
- Week 3: heart rate target: 70% of maximum heart rate
- Week 4: heart rate target: 60% of maximum heart rate
The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist.
The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence.
This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board.
- Conditions
- Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Liver Neoplasm
- Being tested
- Preoperative exercise program
- Keywords
- Gastrointestinal Neoplasms, Exercise, Preoperative Period, Preoperative Care
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Liver Neoplasms, Gastrointestinal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative exercise programOther
Also called Preoperative aerobic exercise short program
Individualized aerobic training program developed by physical therapist using Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks. Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed between 50 to 70% of the maximum heart rate and will be carried on a treadmill or in a stationary bicycle.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative exercise program | Experimental | The individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks.
Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows:
Week 1: heart rate target: 50% of maximum heart rate Week 2: heart rate target: 60% of maximum heart rate Week 3: heart rate target: 70% of maximum heart rate Week 4: heart rate target: 60% of maximum heart rate The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist. Receives: Other: Preoperative exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen comsumption
peak oxygen consumption measured in ml/kg/min using the American College of Sports Medicine's equation
Measured: 4 weeks after the exercise program beginning
Secondary outcomes (3)
exercise-related adverse events
any unexpected reaction secondary to the exercise program. This could be mild (nausea, fall, joint pain, tendinitis) or severe (syncope, fracture, myocardial infarction).
Measured: 3 and 4 weeks after the exercise program beginning
program adherence
frequency of patients who will complete at least the 3 week program.
Measured: 3 weeks after the exercise program beginning.
Peak oxygen comsumption - 3 weeks
peak oxygen consumption measured in ml/kg/min using the American College of Sports
Measured: 3 weeks after the exercise program beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Apr 2017
- Primary completion1 May 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows: * Week 1: heart rate target: 50% of maximum heart rate * Week 2: heart rate target: 60% of maximum heart rate * Week 3: heart rate target: 70% of maximum heart rate * Week 4: heart rate target: 60% of maximum heart rate The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist. The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia, Columbia
- Sponsor type
- Other government
- Collaborators
- Universidad Nacional de Colombia
- Responsible party
- Sponsor
- Investigators
- Oscar A Guevara, MD MSc, Principal investigator, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03423056
- Sponsor's protocol ID
- C41030617-091
- Status last verified
- Jan 2018
- First submitted
- 11 Jan 2018
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Publications
Pardo C, Cendales R. Incidencia, prevalencia y mortalidad de Cáncer en Colombia, 2007-2011: Instituto Nacional de Cancerología; 2015.
Chicharro, JL., Vaquero, AF. (2006). Fisiología del ejercicio. Ed. Médica Panamericana.
Schmidt K, Vogt L, Thiel C, Jager E, Banzer W. Validity of the six-minute walk test in cancer patients. Int J Sports Med. 2013 Jul;34(7):631-6. doi: 10.1055/s-0032-1323746. Epub 2013 Feb 26.
PubMed 23444095Veen EJ, Steenbruggen J, Roukema JA. Classifying surgical complications: a critical appraisal. Arch Surg. 2005 Nov;140(11):1078-83. doi: 10.1001/archsurg.140.11.1078.
PubMed 16301444Worster B, Holmes S. A phenomenological study of the postoperative experiences of patients undergoing surgery for colorectal cancer. Eur J Oncol Nurs. 2009 Dec;13(5):315-22. doi: 10.1016/j.ejon.2009.04.008. Epub 2009 May 30.
PubMed 19482512Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PubMed 15273542Martos-Benitez FD, Gutierrez-Noyola A, Echevarria-Victores A. Postoperative complications and clinical outcomes among patients undergoing thoracic and gastrointestinal cancer surgery: A prospective cohort study. Rev Bras Ter Intensiva. 2016 Jan-Mar;28(1):40-8. doi: 10.5935/0103-507X.20160012.
PubMed 27096675Wilson RJ, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is associated with all-cause mortality after major elective intra-abdominal surgery. Br J Anaesth. 2010 Sep;105(3):297-303. doi: 10.1093/bja/aeq128. Epub 2010 Jun 23.
PubMed 20573634Moyes LH, McCaffer CJ, Carter RC, Fullarton GM, Mackay CK, Forshaw MJ. Cardiopulmonary exercise testing as a predictor of complications in oesophagogastric cancer surgery. Ann R Coll Surg Engl. 2013 Mar;95(2):125-30. doi: 10.1308/rcsann.2013.95.2.125.
PubMed 23484995Jin F, Chung F. Minimizing perioperative adverse events in the elderly. Br J Anaesth. 2001 Oct;87(4):608-24. doi: 10.1093/bja/87.4.608.
PubMed 11878732Loewen GM, Watson D, Kohman L, Herndon JE 2nd, Shennib H, Kernstine K, Olak J, Mador MJ, Harpole D, Sugarbaker D, Green M; Cancer and Leukemia Group B. Preoperative exercise Vo2 measurement for lung resection candidates: results of Cancer and Leukemia Group B Protocol 9238. J Thorac Oncol. 2007 Jul;2(7):619-25. doi: 10.1097/JTO.0b013e318074bba7.
PubMed 17607117Jones LW, Liang Y, Pituskin EN, Battaglini CL, Scott JM, Hornsby WE, Haykowsky M. Effect of exercise training on peak oxygen consumption in patients with cancer: a meta-analysis. Oncologist. 2011;16(1):112-20. doi: 10.1634/theoncologist.2010-0197. Epub 2011 Jan 6.
PubMed 21212429Pouwels S, Stokmans RA, Willigendael EM, Nienhuijs SW, Rosman C, van Ramshorst B, Teijink JA. Preoperative exercise therapy for elective major abdominal surgery: a systematic review. Int J Surg. 2014;12(2):134-40. doi: 10.1016/j.ijsu.2013.11.018. Epub 2013 Dec 8.
PubMed 24325942Boereboom C, Doleman B, Lund JN, Williams JP. Systematic review of pre-operative exercise in colorectal cancer patients. Tech Coloproctol. 2016 Feb;20(2):81-9. doi: 10.1007/s10151-015-1407-1. Epub 2015 Nov 27.
PubMed 26614304Dunne DF, Jack S, Jones RP, Jones L, Lythgoe DT, Malik HZ, Poston GJ, Palmer DH, Fenwick SW. Randomized clinical trial of prehabilitation before planned liver resection. Br J Surg. 2016 Apr;103(5):504-12. doi: 10.1002/bjs.10096. Epub 2016 Feb 11.
PubMed 26864728
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer. A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT03423056
- Acronym / sponsor ID
- C41030617-091
- Conditions
- Stomach Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Liver Neoplasm
- Keywords
- Gastrointestinal Neoplasms, Exercise, Preoperative Period, Preoperative Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia, ColumbiaOther government
- Collaborators
- Universidad Nacional de Colombia
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 6 Feb 2018 (actual)
- 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.
Patients with gastrointestinal cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal surgical procedures.
It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.
Main objective:
To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.
Materials and methods:
This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, hepatic, colon or rectal cancer), without electrocardiographic abnormalities, and scheduled for primary surgery in 4 weeks or more since recruitment
All the enrolled patients will receive a basal aerobic capacity assessment with the 6-minute walk test. Then, two physical therapist will prescribe them a supervised and individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will increase the heart rate target weekly (from 50% to 70% of the maximum heart rate). The aerobic exercise will be carried on a treadmill or in a stationary bicycle.
The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence.
This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board
Detailed description
Gastrointestinal - origin cancer is one of the most frequent causes of cancer worldwide ; the primary surgical management is the standard treatment, however, the postoperative complications rate could be up to 35% . Patients with gastrointestinal - origin cancer often experience physical deconditioning; this could lead to an increased risk of complications, especially when they require major abdominal procedures.
It has been suggested that physical training in the preoperative period could improve their condition, reducing the risk of complications. Although this topic has been investigated, it has not been established yet the best short preoperative aerobic exercise program to enhance the aerobic capacity in patients with gastrointestinal cancer who are going to be to surgical primary management, and consequently, to help patients dealing with the physiological stress involved in a surgical intervention.
Main objective:
To determine the efficacy and safety of a 4 weeks preoperative exercise program in patients with gastrointestinal cancer scheduled for primary surgery.
Materials and methods:
This is a Phase II single arm clinical trial that will include patients between 45 and 70 years, with confirmed gastrointestinal cancer (gastric, liver, colon or rectal cancer), scheduled for surgery in 4 weeks or more since recruitment and without electrocardiographic abnormalities.
The patients will be selected from the gastrointestinal unit surgical schedule. The eligible patients will be invited to participate and after their agreement to participate and to do the informed consent process, they will be scheduled to the basal assessment. This aerobic capacity assessment will be done with the 6-minute walk test.
After the basal measurement, two physical therapists will prescribe an individualized aerobic training program in 3 sessions per week during 4 weeks. Each session will last 50 minutes and will be programmed as follows:
- Week 1: heart rate target: 50% of maximum heart rate
- Week 2: heart rate target: 60% of maximum heart rate
- Week 3: heart rate target: 70% of maximum heart rate
- Week 4: heart rate target: 60% of maximum heart rate
The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist.
The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test. The main efficacy outcome will be peak oxygen consumption (VO2 peak) and the safety outcomes will be exercise-related adverse events and the program adherence.
This protocol was approved by the Instituto Nacional de Cancerología's Ethical Board.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows: * Week 1: heart rate target: 50% of maximum heart rate * Week 2: heart rate target: 60% of maximum heart rate * Week 3: heart rate target: 70% of maximum heart rate * Week 4: heart rate target: 60% of maximum heart rate The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist. The post intervention aerobic capacity will be measured at week 3 and 4 with the 6-minute walk test.
| Arm | Type | Receives |
|---|---|---|
| Preoperative exercise program | Experimental | Other: Preoperative exercise programThe individualized aerobic training program will be developed according to Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks. Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed as follows: Week 1: heart rate target: 50% of maximum heart rate Week 2: heart rate target: 60% of maximum heart rate Week 3: heart rate target: 70% of maximum heart rate Week 4: heart rate target: 60% of maximum heart rate The aerobic exercise will be carried on a treadmill or in a stationary bicycle, according to the patient's preferences and will be supervised by a physical therapist. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 45 to 70 years
- Confirmed diagnosis of gastric, hepatic, colon or rectal cancer.
- Live in Bogota for at least 3 months
- Hemoglobin concentration superior to 10g/dL
- Primary surgery date scheduled in the next 4 weeks or more since eligibility assessment
Key exclusion criteria (7 listed)
- Behavior or cognitive impairment
- musculoskeletal impairment
- any exercise contraindication (fracture or sprains in the last 2 months, severe osteoarthritis, tendinitis)
- Uncontrolled metabolically comorbidities (diabetes, hypertension, hyperlipidemia)
- Presence of obstructive or restrictive pulmonary disease
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 |
|---|---|---|
| Preoperative exercise programAlso: Preoperative aerobic exercise short programIndividualized aerobic training program developed by physical therapist using Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks. Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed between 50 to 70% of the maximum heart rate and will be carried on a treadmill or in a stationary bicycle. | Other | Preoperative exercise program |
Primary outcome
Peak oxygen comsumption
Time frame: 4 weeks after the exercise program beginning
peak oxygen consumption measured in ml/kg/min using the American College of Sports Medicine's equation
3 secondary outcomes
exercise-related adverse events
Time frame: 3 and 4 weeks after the exercise program beginning
program adherence
Time frame: 3 weeks after the exercise program beginning.
Peak oxygen comsumption - 3 weeks
Time frame: 3 weeks after the exercise program beginning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- BackgroundPardo C, Cendales R. Incidencia, prevalencia y mortalidad de Cáncer en Colombia, 2007-2011: Instituto Nacional de Cancerología; 2015.
- BackgroundChicharro, JL., Vaquero, AF. (2006). Fisiología del ejercicio. Ed. Médica Panamericana.
- Background: PubMed 23444095Schmidt K, Vogt L, Thiel C, Jager E, Banzer W. Validity of the six-minute walk test in cancer patients. Int J Sports Med. 2013 Jul;34(7):631-6. doi: 10.1055/s-0032-1323746. Epub 2013 Feb 26.
- Results publication: PubMed 16301444Veen EJ, Steenbruggen J, Roukema JA. Classifying surgical complications: a critical appraisal. Arch Surg. 2005 Nov;140(11):1078-83. doi: 10.1001/archsurg.140.11.1078.
- Results publication: PubMed 19482512Worster B, Holmes S. A phenomenological study of the postoperative experiences of patients undergoing surgery for colorectal cancer. Eur J Oncol Nurs. 2009 Dec;13(5):315-22. doi: 10.1016/j.ejon.2009.04.008. Epub 2009 May 30.
- Results publication: PubMed 15273542Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Results publication: PubMed 27096675Martos-Benitez FD, Gutierrez-Noyola A, Echevarria-Victores A. Postoperative complications and clinical outcomes among patients undergoing thoracic and gastrointestinal cancer surgery: A prospective cohort study. Rev Bras Ter Intensiva. 2016 Jan-Mar;28(1):40-8. doi: 10.5935/0103-507X.20160012.
- Results publication: PubMed 20573634Wilson RJ, Davies S, Yates D, Redman J, Stone M. Impaired functional capacity is associated with all-cause mortality after major elective intra-abdominal surgery. Br J Anaesth. 2010 Sep;105(3):297-303. doi: 10.1093/bja/aeq128. Epub 2010 Jun 23.
- Results publication: PubMed 23484995Moyes LH, McCaffer CJ, Carter RC, Fullarton GM, Mackay CK, Forshaw MJ. Cardiopulmonary exercise testing as a predictor of complications in oesophagogastric cancer surgery. Ann R Coll Surg Engl. 2013 Mar;95(2):125-30. doi: 10.1308/rcsann.2013.95.2.125.
- Results publication: PubMed 11878732Jin F, Chung F. Minimizing perioperative adverse events in the elderly. Br J Anaesth. 2001 Oct;87(4):608-24. doi: 10.1093/bja/87.4.608.
- Results publication: PubMed 17607117Loewen GM, Watson D, Kohman L, Herndon JE 2nd, Shennib H, Kernstine K, Olak J, Mador MJ, Harpole D, Sugarbaker D, Green M; Cancer and Leukemia Group B. Preoperative exercise Vo2 measurement for lung resection candidates: results of Cancer and Leukemia Group B Protocol 9238. J Thorac Oncol. 2007 Jul;2(7):619-25. doi: 10.1097/JTO.0b013e318074bba7.
- Results publication: PubMed 21212429Jones LW, Liang Y, Pituskin EN, Battaglini CL, Scott JM, Hornsby WE, Haykowsky M. Effect of exercise training on peak oxygen consumption in patients with cancer: a meta-analysis. Oncologist. 2011;16(1):112-20. doi: 10.1634/theoncologist.2010-0197. Epub 2011 Jan 6.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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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. This study is not recruiting at the moment.
Oscar A Guevara, MD MSc principal investigator
Instituto Nacional de Cancerologia de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative exercise program in people with Stomach Neoplasms and Colonic Neoplasms, run by Instituto Nacional de Cancerologia, Columbia at 1 site in Colombia.
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 7 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: status not confirmed, as of the sponsor's last update on 24 Jan 2019. 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 Colombia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oscar Guevara, MD, MSc (57+14320106 ext. 5973, oguevarac@cancer.gov.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen comsumption (time frame: 4 weeks after the exercise program beginning). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03423056, which also lists 27 linked publications.
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 24 Jan 2019.