Breast CancerFATSOMCANNCT04867096
Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer
A study testing Physical activity in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2021to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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".
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Besançon
Besançon, 25000
Fabienne MOUGIN-GUILLAUME, fabienne.mougin-guillaume@univ-fcomte.fr
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Physical activity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | Arm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months. Receives: Other: Physical activity |
| Control | No intervention | Arm B : "standard oncologic care". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Total sleep time at 6 months
Evaluated with polysomnography
Measured: 6 months
Secondary outcomes (10)
Change from baseline quality of sleep at 6 months
Evaluated with actimetry
Measured: 6 months
Change from baseline Score of fatigue at 6 months
Evaluated with questionnaire Multidimensional Fatigue Inventory (score between 20 to 100)
Measured: 6 months
Change from baseline body composition at 3 months
Evaluated bioimpedance BMI in Kg/m2
Measured: 3 months.
Score of pain
Evaluated by questionnaire Brief Pain Inventory-Short Form (score between 15 to 150)
Measured: Baseline (T0) , 3 months (T3).
Inflammatory responses
Evaluated with enzyme-linked immunosorbent assay (ELISA)
Measured: Baseline (T0), 3 months (T3).
Level of physical activity
Evaluated with smartwatch withings with number of step
Measured: Baseline (T0), 3 months (T3), 6 months (T6).
Basic respiratory functional exploration
Evaluated by pneumotachography (Sensors Medics MSE, USA) for the evaluation of bronchial volumes and flows.
Measured: Baseline (T0), 3 months (T3).
Level of anxiety
Evaluated by questionnaire Hospital Anxiety and Depression scale (under 7 to more than 11)
Measured: Baseline (T0), 3 months (T3), 6 months (T6).
Concentration of Melatonin
Evaluated by saliva samples
Measured: Baseline (T0), 3 months (T3), 6 months (T6).
Body temperature
Evaluated by thermobuttons
Measured: Baseline (T0), 3 months (T3), 6 months (T6).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start8 Apr 2021
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867096
- Sponsor's protocol ID
- 2020/482
- Acronym
- FATSOMCAN
- Status last verified
- May 2022
- First submitted
- 16 Apr 2021
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drozd C, Curtit E, Jacquinot Q, Roux P, Paget-Bailly S, Gillet V, Meneveau N, Mougin F. Effect of a supervised intermittent exercise program on insomnia in breast cancer patients undergoing chemotherapy. Breast Cancer Res Treat. 2026 Feb 26;216(2):20. doi: 10.1007/s10549-026-07923-7.
PubMed 41746533Drozd C, Curtit E, Jacquinot Q, Marquine C, Mansi L, Chaigneau L, Dobi E, Viot J, Meynard G, Paillard MJ, Goujon M, Roux P, Vernerey D, Gillet V, Bourdin H, Galli S, Meneveau N, Mougin F. A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study. BMC Cancer. 2023 May 17;23(1):449. doi: 10.1186/s12885-023-10902-6.
PubMed 37198562
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Supervised Exercise on Sleep in Patients With Non Metastatic Breast Cancer During Chemotherapy
- ClinicalTrials.gov ID
- NCT04867096
- Acronym / sponsor ID
- FATSOMCAN / 2020/482
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Other: Physical activityArm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months. |
| Control | No intervention | –Arm B : "standard oncologic care". |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityPatients 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. | Other | Physical activity intervention |
Primary outcome
Change from baseline Total sleep time at 6 months
Time frame: 6 months
Evaluated with polysomnography
10 secondary outcomes
Change from baseline quality of sleep at 6 months
Time frame: 6 months
Change from baseline Score of fatigue at 6 months
Time frame: 6 months
Change from baseline body composition at 3 months
Time frame: 3 months.
Score of pain
Time frame: Baseline (T0) , 3 months (T3).
Inflammatory responses
Time frame: Baseline (T0), 3 months (T3).
Level of physical activity
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
Basic respiratory functional exploration
Time frame: Baseline (T0), 3 months (T3).
Level of anxiety
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
Concentration of Melatonin
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
Body temperature
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 41746533Drozd C, Curtit E, Jacquinot Q, Roux P, Paget-Bailly S, Gillet V, Meneveau N, Mougin F. Effect of a supervised intermittent exercise program on insomnia in breast cancer patients undergoing chemotherapy. Breast Cancer Res Treat. 2026 Feb 26;216(2):20. doi: 10.1007/s10549-026-07923-7.
- Derived from this study: PubMed 37198562Drozd C, Curtit E, Jacquinot Q, Marquine C, Mansi L, Chaigneau L, Dobi E, Viot J, Meynard G, Paillard MJ, Goujon M, Roux P, Vernerey D, Gillet V, Bourdin H, Galli S, Meneveau N, Mougin F. A randomized trial to evaluate the effects of a supervised exercise program on insomnia in patients with non-metastatic breast cancer undergoing chemotherapy: design of the FATSOMCAN study. BMC Cancer. 2023 May 17;23(1):449. doi: 10.1186/s12885-023-10902-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Breast Cancer, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MOUGIN-GUILLAUME Fabienne (0363082585, fabienne.mougin-guillaume@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Total sleep time at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04867096, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.