An interventional study of Preoperative exercise program in Stomach Neoplasms, Colonic Neoplasms and Rectal Neoplasms, sponsored by Instituto Nacional de Cancerologia, Columbia. Status unknown at 1 site in Colombia. Open to participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-24.
Sponsored by Instituto Nacional de Cancerologia, Columbia · Not applicable, Interventional, and Supportive care
Among 22 studies in Stomach Neoplasms with a site in Colombia — 7 open to participants now, 8 under way, 2 of them phase 3. Stomach Neoplasms · Colombia.
Among the 22 studies in Stomach Neoplasms with a site in Colombia, this one is the 13th largest by planned enrollment of the 15 interventional ones that give a count, is the only one that started in 2017, is the only one with no phase, and was the 7th registered.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
Browse Stomach Neoplasms studies →7 of the 22 studies in Stomach Neoplasms with a site in Colombia are open now. Recruiting first, the newest first:
Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Sites in Colombia
Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Sites in Colombia
Bristol-Myers Squibb · Sites in Colombia, United States, Argentina and 17 more countries
Fundación Santa Fe de Bogota · Sites in Colombia
Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Sites in Colombia
A study can be open while its sites in Colombia have not opened yet or have stopped. Only those recruiting at a site in Colombia →
Of the 702 Stomach Neoplasms studies recruiting now, 375 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 68 take healthy volunteers.
This study: 45 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 9
First in 2002; this study’s year is marked. 1 started in 2017.
This study's planned enrollment of 40 is below the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Median enrollment 515 across the 15 interventional studies, 150 across the 7 observational. Of the 11 that completed or were terminated, 6 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
13 of 22 have an industry lead sponsor. The 10 most frequent:
Instituto Nacional de Cancerologia, Columbia is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Instituto Nacional de Cancerologia, Columbia has 1 study filed under Stomach Neoplasms — fewer than ten, so there is no comparison to draw.
4 of the studies in Stomach Neoplasms with a site in Colombia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07816263Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento AnguloGuaraná Supplementation for Cancer-Related Fatigue | 2027-01-18 |
| NCT07856212Fundación Santa Fe de BogotaMaintenance Therapy in Metastatic Gastric Cancer: A Multicenter Retrospective Study in Colombia | 2027-03-01 |
| NCT07741435Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento AnguloMethylation Profile Test (Methylscape) in Body Fluids for Multi-Cancer Detection and Monitoring in Colombia | 2027-06-04 |
| NCT07859254Fundación Santa Fe de BogotaPathological Response to Perioperative FLOT in Gastric Adenocarcinoma | 2027-10-01 |
Among the 22 studies in Stomach Neoplasms with a site in Colombia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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
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:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Preoperative exercise 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.
Also known as: Preoperative aerobic exercise short program
Peak oxygen comsumption
peak oxygen consumption measured in ml/kg/min using the American College of Sports Medicine's equation
Time frame: 4 weeks after the exercise program beginning
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).
Time frame: 3 and 4 weeks after the exercise program beginning
program adherence
frequency of patients who will complete at least the 3 week program.
Time frame: 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
Time frame: 3 weeks after the exercise program beginning
Plan to share: No — IPD will not be shared with other researchers
Started Apr 2017 (actual). Primary completion is estimated for May 2019, 25 months after the start.
Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 25 months is below that.
Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Instituto Nacional de Cancerologia, Columbia