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

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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".

Sites / Locations

  • CHU BesançonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical activity intervention

Control

Arm Description

Arm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months.

Arm B : "standard oncologic care".

Outcomes

Primary Outcome Measures

Change from baseline Total sleep time at 6 months
Evaluated with polysomnography

Secondary Outcome Measures

Change from baseline quality of sleep at 6 months
Evaluated with actimetry
Change from baseline Score of fatigue at 6 months
Evaluated with questionnaire Multidimensional Fatigue Inventory (score between 20 to 100)
Change from baseline body composition at 3 months
Evaluated bioimpedance BMI in Kg/m2
Score of pain
Evaluated by questionnaire Brief Pain Inventory-Short Form (score between 15 to 150)
Inflammatory responses
Evaluated with enzyme-linked immunosorbent assay (ELISA)
Level of physical activity
Evaluated with smartwatch withings with number of step
Basic respiratory functional exploration
Evaluated by pneumotachography (Sensors Medics MSE, USA) for the evaluation of bronchial volumes and flows.
Level of anxiety
Evaluated by questionnaire Hospital Anxiety and Depression scale (under 7 to more than 11)
Concentration of Melatonin
Evaluated by saliva samples
Body temperature
Evaluated by thermobuttons

Full Information

First Posted
April 16, 2021
Last Updated
May 31, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT04867096
Brief Title
Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer
Acronym
FATSOMCAN
Official Title
Effects of a Supervised Exercise on Sleep in Patients With Non Metastatic Breast Cancer During Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity intervention
Arm Type
Experimental
Arm Description
Arm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Arm B : "standard oncologic care".
Intervention Type
Other
Intervention Name(s)
Physical activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline Total sleep time at 6 months
Description
Evaluated with polysomnography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline quality of sleep at 6 months
Description
Evaluated with actimetry
Time Frame
6 months
Title
Change from baseline Score of fatigue at 6 months
Description
Evaluated with questionnaire Multidimensional Fatigue Inventory (score between 20 to 100)
Time Frame
6 months
Title
Change from baseline body composition at 3 months
Description
Evaluated bioimpedance BMI in Kg/m2
Time Frame
3 months.
Title
Score of pain
Description
Evaluated by questionnaire Brief Pain Inventory-Short Form (score between 15 to 150)
Time Frame
Baseline (T0) , 3 months (T3).
Title
Inflammatory responses
Description
Evaluated with enzyme-linked immunosorbent assay (ELISA)
Time Frame
Baseline (T0), 3 months (T3).
Title
Level of physical activity
Description
Evaluated with smartwatch withings with number of step
Time Frame
Baseline (T0), 3 months (T3), 6 months (T6).
Title
Basic respiratory functional exploration
Description
Evaluated by pneumotachography (Sensors Medics MSE, USA) for the evaluation of bronchial volumes and flows.
Time Frame
Baseline (T0), 3 months (T3).
Title
Level of anxiety
Description
Evaluated by questionnaire Hospital Anxiety and Depression scale (under 7 to more than 11)
Time Frame
Baseline (T0), 3 months (T3), 6 months (T6).
Title
Concentration of Melatonin
Description
Evaluated by saliva samples
Time Frame
Baseline (T0), 3 months (T3), 6 months (T6).
Title
Body temperature
Description
Evaluated by thermobuttons
Time Frame
Baseline (T0), 3 months (T3), 6 months (T6).

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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".
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MOUGIN-GUILLAUME Fabienne
Phone
0363082585
Email
fabienne.mougin-guillaume@univ-fcomte.fr
Facility Information:
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabienne MOUGIN-GUILLAUME
Email
fabienne.mougin-guillaume@univ-fcomte.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer

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