HER2 Positive Breast CancerAPACAN2NCT02963363
Adapted Physical Activity for Breast Cancer HER2 Positive Patient
A study testing Home-based Adapted Physical Activity in people with HER2 Positive Breast Cancer, run by Centre Jean Perrin at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2 Positive Breast Cancer
- What is being tested?
- Home-based Adapted Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2018to 11 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2
The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.
Read the 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.
- Conditions
- HER2 Positive Breast Cancer
- Being tested
- Home-based Adapted Physical Activity
- Keywords
- Breast cancer, HER2+, Adapted physical activity, Neoadjuvant chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based Adapted Physical ActivityOther
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
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Home-Based Adapted Physical Activity intervention during neoadjuvant chemotherapy :
150 minutes per week of aerobic and muscle strengthening exercises during 18 weeks Receives: Other: Home-based Adapted Physical Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy)
Secondary outcomes (12)
Longitudinal evolution of RPAQ score
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2016 (estimated)
- Study start27 Apr 2018
- Primary completion19 Aug 2022
- Study completion11 Aug 2023
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HER2 Positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier DURANDO, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02963363
- Sponsor's protocol ID
- 2016-A01344-47
- Acronym
- APACAN2
- Status last verified
- Nov 2023
- First submitted
- 7 Nov 2016
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34966667
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of an Adapted Physical Activity (APA) for Breast Cancer Patients Treated by Neoadjuvant Chemotherapy and Targeted Therapy Against HER2
- ClinicalTrials.gov ID
- NCT02963363
- Acronym / sponsor ID
- APACAN2 / 2016-A01344-47
- Conditions
- HER2 Positive Breast Cancer
- Keywords
- Breast cancer, HER2+, Adapted physical activity, Neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 27 Apr 2018 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 15 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility of a home-based adapted physical activity during neoadjuvant chemotherapy for HER2+ breast cancer.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Other: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based Adapted Physical ActivityHome-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 | Other | Interventional |
Primary outcome
Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment
Time frame: 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)
12 secondary outcomes
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
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
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
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
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)
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
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Derived from this study: PubMed 34966667Ginzac 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier DURANDO, MD principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Adapted Physical Activity in people with HER2 Positive Breast Cancer, run by Centre Jean Perrin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients reaching international physical activity recommendations for post-neoadjuvant chemotherapy assessment (time frame: Change from baseline (T0: before neoadjuvant chemotherapy) at the 5 months (T1: end of neoadjuvant chemotherapy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02963363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.