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Adapted Physical Activity for Breast Cancer HER2 Positive Patient

NCT02963363 — Not applicable, Terminated, 36 participants, Centre Jean Perrin

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Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2

RegistryNCT02963363, acronym APACAN2
StatusTerminated - Insufficient recruitment
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, supportive care
Enrollment36 (Actual)
SponsorCentre Jean Perrin (Other)
ConditionsHER2 Positive Breast Cancer
InterventionsHome-based Adapted Physical Activity (Other)
Datesstart 2018-04-27, primary completion 2022-08-19, completion 2023-08-11, first posted 2016-11-15, last updated 2023-11-24
Locations1 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

ArmTypeInterventionsDescription
InterventionalExperimentalOther: Home-based Adapted Physical ActivityHome-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)

FacilityCityCountryStatus
Centre Jean PerrinClermont-FerrandFrance

+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

My Notes