Clinical trial NCT03423056: Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer.
Official title: Efficacy and Safety of a Preoperative Aerobic Exercise Program in Patients With Gastrointestinal Cancer. A Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stomach Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Liver Neoplasm
Keywords: Gastrointestinal Neoplasms
Exercise
Preoperative Period
Preoperative Care
Lead sponsor: Instituto Nacional de Cancerologia, Columbia
Sponsor class: OTHER_GOV
Collaborators: name: Universidad Nacional de Colombia
First posted: 2018-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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.

Primary outcomes:
measure: Peak oxygen comsumption
timeFrame: 4 weeks after the exercise program beginning
Secondary outcomes:
measure: exercise-related adverse events
timeFrame: 3 and 4 weeks after the exercise program beginning
measure: program adherence
timeFrame: 3 weeks after the exercise program beginning.
measure: Peak oxygen comsumption - 3 weeks
timeFrame: 3 weeks after the exercise program beginning
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerología
state: Cundinamarca
Study officials:
affiliation: Instituto Nacional de Cancerologia de Mexico
name: Oscar A Guevara, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pardo C, Cendales R. Incidencia, prevalencia y mortalidad de Cáncer en Colombia, 2007-2011: Instituto Nacional de Cancerología; 2015.
citation: Chicharro, JL., Vaquero, AF. (2006). Fisiología del ejercicio. Ed. Médica Panamericana.
citation: 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.
citation: Veen 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.
citation: Worster 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.
citation: Dindo 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.
citation: Martos-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.
citation: Wilson 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.
citation: Moyes 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.
citation: Jin 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.
citation: Loewen 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.
citation: Jones 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.
citation: Pouwels 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.
citation: Boereboom 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.
citation: Dunne 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.
citation: Ministerio de la Proteccion Social (Colombia). Guía de práctica clínica (GPC) para la detección temprana, el diagnóstico, tratamiento integral, seguimiento y rehabilitación de pacientes con diagnostico de cáncer de colon y recto 2013.
citation: Van Cutsem E, Sagaert X, Topal B, Haustermans K, Prenen H. Gastric cancer. Lancet. 2016 Nov 26;388(10060):2654-2664. doi: 10.1016/S0140-6736(16)30354-3. Epub 2016 May 5.
citation: Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.
citation: Levett DZ, Grocott MP. Cardiopulmonary exercise testing, prehabilitation, and Enhanced Recovery After Surgery (ERAS). Can J Anaesth. 2015 Feb;62(2):131-42. doi: 10.1007/s12630-014-0307-6. Epub 2015 Jan 22.
citation: Gupta R, Gan TJ. Preoperative Nutrition and Prehabilitation. Anesthesiol Clin. 2016 Mar;34(1):143-53. doi: 10.1016/j.anclin.2015.10.012.
citation: Knols R, Aaronson NK, Uebelhart D, Fransen J, Aufdemkampe G. Physical exercise in cancer patients during and after medical treatment: a systematic review of randomized and controlled clinical trials. J Clin Oncol. 2005 Jun 1;23(16):3830-42. doi: 10.1200/JCO.2005.02.148.
citation: Jones LW, Eves ND, Haykowsky M, Freedland SJ, Mackey JR. Exercise intolerance in cancer and the role of exercise therapy to reverse dysfunction. Lancet Oncol. 2009 Jun;10(6):598-605. doi: 10.1016/S1470-2045(09)70031-2.
citation: Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.
citation: Alcalde-Escribano JR-L, P. Acosta,F. Landa, I. Lorenzo,S, Villeta-Plaza RJE. Estudio Delphi para el desarrollo de pautas de indicación de pruebas preoperatorias. Consenso de anestesiólogos y cirujanos. Rev Calidad Asistencial. 2002;17(1):34-42.
citation: Wilmore, JH., Costill, DL. (2004). Fisiología del esfuerzo y del deporte. Editorial Paidotribo.
citation: Albouaini K, Egred M, Alahmar A, Wright DJ. Cardiopulmonary exercise testing and its application. Postgrad Med J. 2007 Nov;83(985):675-82. doi: 10.1136/hrt.2007.121558.
citation: ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.