Breast Cancer
Conditions
Keywords
adapted physical activity, cognitive functions
Brief summary
Breast cancer is the most frequent cancer in women in western countries. The improvement of therapeutic management associated to the developement of supportive care allows patient to live longer in better conditions. But several studies have showed the deleterious impact of treatment such as chemotherapy on cognition. To limit these damages, non therapeutic approaches such as Adapted Physical Activity (APA) have been developped. The goal of this study is to evaluate the benefit of APA program on cognitive functions in patients with locally advanced breast cancer.
Detailed description
Patient with cognitive complaint will be randomized in two groups : * Experimental group : Immediate APA program (after randomization) * Standard group : Delayed APA program (3 months after randomization) APA program contains 10 sessions of APA within five weeks (twice a week). Each session is composed of 5 exercises (each made of 3 serial of 7 repetitions in slow speed). A cognitive and quality of life assessments will occur in two groups at 3 and 6 months after randomization. The primary objective of the study is to evaluate the impact of APA program on the improvement of cognitive functions in patients with breast cancer who have been treated by adjuvant chemotherapy.
Interventions
OTHERimmediate APA program
10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized
OTHERdelayed APA program
10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized
Sponsors
Centre Henri Becquerel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women * More than 18 years old * Locally advanced breast cancer * Patient who undergone surgery * Cognitive complaint (FACT-COG inferior or equal to 8/16) * No metastasis at the inclusion * Patient who received adjuvant therapy by chemotherapy * Patient with a social protection * Barbizet scale Superior or equal to 3 * No neurological history * No medical contraindication to APA * Inform consent signed
Exclusion criteria
* Metastatic breast cancer * History of other cancer (in 5 years before inclusion) * Current chemotherapy or radiotherapy * Chemotherapy or radiotherapy ended for more than 6 months * Current APA program * Blood transfusion for less than 6 mois * Minimal mental score inferior to normal * Patient no able to respond to the cognitive test * Patient no able to realize APA program * Drug use * Alcohol abuse * Patient Under guardianship or curatorship or deprived of liberty
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proportion of patient with an increase of Functional Assessment of Cancer Therapy-Cognitive Function (FACT-COG) result | After APA program | Proportion of patient with an increase superior or equal to seven points between FACT-COG at the inclusion and FACT-COG after APA program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improval of quality of life | After APA program | Impact of APA on quality of life (FACT-B result) |
| Comparison of immediate APA and delayed APA on quality of life | 30 months | Comparison between FACT-B, FACT-COG and FACIT-F results in the two groups |
| Study of relations between cognitive functions and quality pf life | After APA program | Correlation between patient questionnaire and data of psychological tests done by neuropsychologist |
Countries
France
Outcome results
None listed