Impact of Exercise and Hyperlipidic Meal on Free Circulating DNA in Patients With Metastatic Colonic Cancer and Healthy Subjects
NCT ID: NCT05147545
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2023-09-30
2024-06-30
Brief Summary
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Detailed Description
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40 patients with colon cancer will be enrolled for a two visit study. The first visit will be planned at the first cycle of chemotherapy, before the chemotherapy. At this visit, the influence of exercise on plasma concentrations of circulating free DNA will also be studied in 40 patients with colon cancer. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 minutes at the 30 Watt level of the ergometer) and after 15, 30 and 60 minutes of recovery. After an hour of recovery, the subject will be proposed to consume a meal rich in fat. The circulating DNA will be measured 2 hours after the end of the meal. The second visit will be planned at the first second of chemotherapy, before the chemotherapy. Free circulating DNA will be measured on an empty stomach after 1 hour of rest, then immediately after low-intensity physical effort : pedaling 3 min at the 30 Watt level of the ergometer, and after 15, 30 and 60 minutes of recovery.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Subjects free of malignancy
Moderate intensity physical effort and meal (once)
Moderate intensity physical effort
Pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer
Hyperlipidic meal
Eating an hyperlipidic meal 60 minutes after a physical effort
Measure of circulating DNA
Multiple measure of circulating DNA: on an empty stomach, at the end of the physical effort, after 15, 30 and 60 minutes of rest, 120 minutes after an hyperlipidic meal.
An additional measure will occur for subjects free of malignancy during the effort.
Patients with colon cancer
Low intensity physical effort and meal (visit 1, day of cycle 1 chemotherapy) and low intensity physical effort (visit 2, day of cycle 2 chemotherapy)
Low intensity physical effort
Pedaling 3 minutes at the 30 Watt level of the ergometer
Hyperlipidic meal
Eating an hyperlipidic meal 60 minutes after a physical effort
Measure of circulating DNA
Multiple measure of circulating DNA: on an empty stomach, at the end of the physical effort, after 15, 30 and 60 minutes of rest, 120 minutes after an hyperlipidic meal.
An additional measure will occur for subjects free of malignancy during the effort.
Interventions
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Moderate intensity physical effort
Pedaling 15 minutes at 75 Watt then 100 Watt of the ergometer
Low intensity physical effort
Pedaling 3 minutes at the 30 Watt level of the ergometer
Hyperlipidic meal
Eating an hyperlipidic meal 60 minutes after a physical effort
Measure of circulating DNA
Multiple measure of circulating DNA: on an empty stomach, at the end of the physical effort, after 15, 30 and 60 minutes of rest, 120 minutes after an hyperlipidic meal.
An additional measure will occur for subjects free of malignancy during the effort.
Eligibility Criteria
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Inclusion Criteria
* men or women 40-70 yrs aged
2. Patients with colon cancer
* men or women 18-85 yrs aged
* Biopsy-proven colon cancer with indication to chemiotherapy
* Chemiotherapy (first line or second line) not started
Exclusion Criteria
* Ischemic cardiac history
* known heart disease
* blood hemoglobin concentration \<8g / dl
* Acute or chronic systemic illnesses, (apart from diabetes, essential or secondary hypertension for patients)
* Pregnancy or breastfeeding or in progress
2. Subjects free of malignancy
* Cardiovascular risk factor (active smoking or greater than 10 pack-years, diabetes, hypertension or known dyslipidemia not controlled by the diet)
* Glomerular filtration rate estimated by the CKD epi (Chronic Kidney Disease - Epidemiology Collaboration) formula \< 60 ml.min-1.1.73 m-²
* Contraindication to exercise
* Drug taking in progress (except estrogen-progestogen contraception)
18 Years
85 Years
ALL
Yes
Sponsors
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Eurofins Biomnis
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Pierre LAURENT-PUIG, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Assistance Publique Hôpitaux de Paris, Hôpital européen Georges Pompidou
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IDRCB 2020-A02872-37
Identifier Type: OTHER
Identifier Source: secondary_id
APHP201461
Identifier Type: OTHER
Identifier Source: secondary_id
APHP201461
Identifier Type: -
Identifier Source: org_study_id
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