Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2
| Registry | NCT02963363, acronym APACAN2 |
| Status | Terminated - Insufficient recruitment |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, supportive care |
| Enrollment | 36 (Actual) |
| Sponsor | Centre Jean Perrin (Other) |
| Conditions | HER2 Positive Breast Cancer |
| Interventions | Home-based Adapted Physical Activity (Other) |
| Dates | start 2018-04-27, primary completion 2022-08-19, completion 2023-08-11, first posted 2016-11-15, last updated 2023-11-24 |
| Locations | 1 site in France |
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-Summary
The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.
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+Detailed description
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.
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Interventional | Experimental | Other: Home-based Adapted Physical Activity | Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy :
150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks |
- Home-based Adapted Physical Activity (Other): 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
+Outcome measures
Primary outcomes
- Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment [Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy)]: Time spent to physical activity and sedentariness will be evaluated by Recent Physical Activity Questionnaire (RPAQ)
Secondary outcomes
- Longitudinal evolution of RPAQ score [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 [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 [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 [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]: BMI
- Anthropometrics measurements [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]: Hip circumference (cm)
- Physical capacity : six-minutes walking distance test [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 [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 [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 measure is optional
- Lipid profile : total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides [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 [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 [At each cycle of neoadjuvant chemotherapy : every three weeks during 5 months]: frequency of dose reduction (%), of postponement (%) or of treatment discontinuation (%)
- Assessment of physical activity level using a validated smartphone application (eMouveRecherche) [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]: Including sedentariness time
+Eligibility
Sex: Female, ages: 18 Years to any
Inclusion Criteria:
* Women > 18 years old
* Patient with HER2 (Human Epidermal growth factor Receptor 2) positive breast cancer histologically proven, eligible for neoadjuvant chemotherapy and targeted therapy against HER-2
* Affiliation to the French social security scheme
* Patient who signed the participation consent before entering the trial
* Medical fitness certificate for sport
Exclusion Criteria:
* Diagnosis of a second malignancy in the past 5 years, with the exception of a basal cell skin cancer
* Metastatic cancer
* Karnofsky index ≤ 90%
* Men
* Pregnant women
* Significant psychiatric or neurological abnormality
* Patient deprived of liberty by a court or administrative
* Contraindication for physical activity
* Patient unable to complete questionnaires (language barrier)
* Participation in a clinical trial with the same objective
+Locations (1)
| Facility | City | Country | Status |
|---|
| Centre Jean Perrin | Clermont-Ferrand | France | |
+Publications
- Results publication: Ginzac A, Bernadach M, Molnar I, Duclos M, Thivat E, Durando X. Adapted Physical Activity for Breast Cancer Patients Treated with Neoadjuvant Chemotherapy and Trastuzumab Against HER2 (APACAN2): A Protocol for a Feasibility Study. Front Oncol. 2021 Dec 13;11:744609. doi: 10.3389/fonc.2021.744609. eCollection 2021. PMID 34966667
+Investigators
- Xavier DURANDO, MD, Principal investigator, Centre Jean Perrin