An interventional study of Home-based Adapted Physical Activity in HER2 Positive Breast Cancer, sponsored by Centre Jean Perrin. Terminated at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Centre Jean Perrin · Not applicable, Interventional, and Supportive care
The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.
After the assessment of their physical fitness, a home-based adapted physical activity program composed by aerobic and muscle strengthening exercises will be delivered to each patient. The aim of the intervention is to reach international recommendation in a progressive way during neoadjuvant chemotherapy.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 36 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Jean Perrin is the lead sponsor of 55 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy : 150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks
Other: Home-based Adapted Physical Activity
Home-based adapted physical activity to attend progressively 150 minutes of physical activity per week at the end of neoadjuvant chemotherapy. 5 times 30 minutes of walking + 3 times 30 minutes of muscle strengthening exercises per week during 18 weeks
Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment
Time spent to physical activity and sedentariness will be evaluated by Recent Physical Activity Questionnaire (RPAQ)
Time frame: Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy)
Longitudinal evolution of RPAQ score
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Quality of life : Quality of Life Questionnaire-C30
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Asthenia : Multidimensional Fatigue Inventory-20
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Anthropometrics measurements
BMI
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Anthropometrics measurements
Hip circumference (cm)
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Physical capacity : six-minutes walking distance test
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Physical capacity : Voluntary muscular strength
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Physical capacity : VO2max
This measure is optional
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Lipid profile : total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Ventricular ejection fraction assessed by echocardiography or cardiac scintigraphy
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
Changes of cancer treatment
frequency of dose reduction (%), of postponement (%) or of treatment discontinuation (%)
Time frame: At each cycle of neoadjuvant chemotherapy : every three weeks during 5 months
Assessment of physical activity level using a validated smartphone application (eMouveRecherche)
Including sedentariness time
Time frame: Before (T0) and at the end (T1 : + 5 months) of neoadjuvant chemotherapy + before (T2 : + 8 months) and at the end (T3 : 20 month) of targeted therapy
This study is terminated, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Centre Jean Perrin