An interventional study of Physical activity in Breast Cancer, sponsored by Centre Hospitalier Universitaire de Besancon. Status unknown at 1 site in France. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-01.
Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Supportive care
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Arm A : "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months.
Other: Physical activity
Arm B : "standard oncologic care".
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.
Change from baseline Total sleep time at 6 months
Evaluated with polysomnography
Time frame: 6 months
Change from baseline quality of sleep at 6 months
Evaluated with actimetry
Time frame: 6 months
Change from baseline Score of fatigue at 6 months
Evaluated with questionnaire Multidimensional Fatigue Inventory (score between 20 to 100)
Time frame: 6 months
Change from baseline body composition at 3 months
Evaluated bioimpedance BMI in Kg/m2
Time frame: 3 months.
Score of pain
Evaluated by questionnaire Brief Pain Inventory-Short Form (score between 15 to 150)
Time frame: Baseline (T0) , 3 months (T3).
Inflammatory responses
Evaluated with enzyme-linked immunosorbent assay (ELISA)
Time frame: Baseline (T0), 3 months (T3).
Level of physical activity
Evaluated with smartwatch withings with number of step
Time frame: 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.
Time frame: Baseline (T0), 3 months (T3).
Level of anxiety
Evaluated by questionnaire Hospital Anxiety and Depression scale (under 7 to more than 11)
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
Concentration of Melatonin
Evaluated by saliva samples
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
Body temperature
Evaluated by thermobuttons
Time frame: Baseline (T0), 3 months (T3), 6 months (T6).
Plan to share: No
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This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Besancon