Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer (FATSOMCAN)

May 31, 2022 updated by: Centre Hospitalier Universitaire de Besancon

Effects of a Supervised Exercise on Sleep in Patients With Non Metastatic Breast Cancer During Chemotherapy

Insomnia affects about 60% of the patients treated with radio-chemotherapy, a percentage twice higher compared to that observed in the general population. This sleep disorder increases cancer-related fatigue (CRF), the side effect most often reported by patients. Conversely, it is well accepted that adapted physical activity (APA) improves tolerance to treatment, decreases the risk of recurrence, increases survival, and reduces CRF. The present study aims to evaluate, in non-metastatic breast cancer patients, the composition and architecture of sleep by ambulatory polysomnography and to verify the effects of an APA rehabilitation program (3 times a week during 12 weeks), on the quality and quantity of sleep, daytime sleepiness. The biological markers: melatonin and body temperature will be studied to better understand the chronobiological mechanisms of the sleep-wake rhythm. Finally, the physiological responses to exercise, pain, CRF and finally quality of life will be studied at the beginning, at the end of the program and at a distance from it. Improved sleep-wake rhythm by a physical activity may reduce CRF, prevent recurrence and comorbidities.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients aged 18 to 65
  • Patients with non-metastatic breast cancer undergoing chemotherapy
  • Patients with insomnia
  • Certificate of non-contraindication to the practice of physical activity
  • Women who have been postmenopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
  • Signature of informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
  • Affiliation to a French social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

  • Patients treated with melatonin or taking hypnotics
  • Patients with metastases
  • Oxygen saturation at rest (SaO2) ≤ 92%
  • Patients without insomnia and / or sleep disorders
  • Autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis)
  • Symptomatic osteoarthritis, cardiovascular disease (angina pectoris or uncontrolled hypertension) or lung disease (chronic obstructive pulmonary disease)
  • Patients suffering from malnutrition (BMI <18 kg.m-2) or weight loss> 10% during the previous 3 months
  • Patients with psychiatric or cognitive disorders deemed unsuitable for physical activity
  • Pregnant or breastfeeding women
  • Legal incapacity or limited legal capacity
  • Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
  • Subject without health insurance
  • Subject being in the period of exclusion from another study or provided for by the "national file of volunteers".

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Physical activity intervention
Arm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months.
Other: Physical activity
Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week.
NO_INTERVENTION: Control
Arm B : "standard oncologic care".

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline Total sleep time at 6 months
Time Frame: 6 months
Evaluated with polysomnography
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline quality of sleep at 6 months
Time Frame: 6 months
Evaluated with actimetry
6 months
Change from baseline Score of fatigue at 6 months
Time Frame: 6 months
Evaluated with questionnaire Multidimensional Fatigue Inventory (score between 20 to 100)
6 months
Change from baseline body composition at 3 months
Time Frame: 3 months.
Evaluated bioimpedance BMI in Kg/m2
3 months.
Score of pain
Time Frame: Baseline (T0) , 3 months (T3).
Evaluated by questionnaire Brief Pain Inventory-Short Form (score between 15 to 150)
Baseline (T0) , 3 months (T3).
Inflammatory responses
Time Frame: Baseline (T0), 3 months (T3).
Evaluated with enzyme-linked immunosorbent assay (ELISA)
Baseline (T0), 3 months (T3).
Level of physical activity
Time Frame: Baseline (T0), 3 months (T3), 6 months (T6).
Evaluated with smartwatch withings with number of step
Baseline (T0), 3 months (T3), 6 months (T6).
Basic respiratory functional exploration
Time Frame: Baseline (T0), 3 months (T3).
Evaluated by pneumotachography (Sensors Medics MSE, USA) for the evaluation of bronchial volumes and flows.
Baseline (T0), 3 months (T3).
Level of anxiety
Time Frame: Baseline (T0), 3 months (T3), 6 months (T6).
Evaluated by questionnaire Hospital Anxiety and Depression scale (under 7 to more than 11)
Baseline (T0), 3 months (T3), 6 months (T6).
Concentration of Melatonin
Time Frame: Baseline (T0), 3 months (T3), 6 months (T6).
Evaluated by saliva samples
Baseline (T0), 3 months (T3), 6 months (T6).
Body temperature
Time Frame: Baseline (T0), 3 months (T3), 6 months (T6).
Evaluated by thermobuttons
Baseline (T0), 3 months (T3), 6 months (T6).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020/482

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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