Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer

NCT02433067 | Terminated

• 1 other identifier: UFranche-Comte
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Ejection Fraction (LVEF)

  evaluated with echocardiography

  The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change

Secondary Outcomes (11)

• Weight and volume of left and right ventricular

  baseline (T0), 3 months (T3) and 6 months (T6)

• Body composition

  baseline (T0), 3 months (T3) and 6 months (T6)

• Metabolic responses

  baseline (T0), 3 months (T3) and 6 months (T6)

• Maximal voluntary quadriceps

  baseline (T0), 3 months (T3) and 6 months (T6)

• score of Quality of life

  Baseline (T0), 3 months (T3) and 6 months (T6)

Study Arms (2)

Physical activity intervention

EXPERIMENTAL

\- Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months

Other: Physical activity intervention

Control group

ACTIVE COMPARATOR

\- Arm B (control group) "standard oncologic care"

Other: Control Group

Interventions

Physical activity intervention OTHER

Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week.

Physical activity intervention

Control Group OTHER

standard oncologic care

Control group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 85 years
• First breast cancer HER2 + histologically confirmed,
• WHO grade Performance Index ≤1
• Normal renal function (creatinine clearance ≥ 60 ml min-1)
• Normal heart function with LVEF ≥ 50%
• Normal liver function (AST and ALT normal)
• Physical activity certificate issued by a cardiologist or an oncologist,
• Active contraception or postmenopausal

You may not qualify if:

• Patients aged under 18 and over 85
• Patients having no breast cancer HER2+
• Patients with metastases
• Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%),
• Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)
• Symptomatic osteoarthritis,
• Cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease)
• Patients suffering from malnutrition (Body Mass Index (BMI) \<18 kg m-2) or weight loss of over 10% during the last 3 months,
• Patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity
• Pregnant or lactating Patients.

Sponsors & Collaborators

• University of Franche-Comté: lead
• Ligue contre le cancer, France: collaborator
• Centre Hospitalier Universitaire de Besancon: collaborator

Study Sites (1)

University Hospital

Besançon, Doubs, 25000, France

Location

Related Publications (3)

• Jacquinot Q, Ennequin G, Falcoz A, Sawyer D, Meneveau N, Mougin F. Exercise training decreases Neuregulin-1 concentrations in HER2-positive breast cancer patients undergoing adjuvant trastuzumab: the CARDAPAC study. Breast Cancer Res Treat. 2026 Feb 4;215(3):69. doi: 10.1007/s10549-026-07903-x.

  PMID: 41636910 DERIVED

• Jacquinot Q, Meneveau N, Falcoz A, Bouhaddi M, Roux P, Degano B, Chatot M, Curtit E, Mansi L, Paillard MJ, Bazan F, Chaigneau L, Dobi E, Meynard G, Vernerey D, Pivot X, Mougin F. Cardiotoxicity is mitigated after a supervised exercise program in HER2-positive breast cancer undergoing adjuvant trastuzumab. Front Cardiovasc Med. 2022 Sep 23;9:1000846. doi: 10.3389/fcvm.2022.1000846. eCollection 2022.

  PMID: 36211552 DERIVED

• Jacquinot Q, Meneveau N, Chatot M, Bonnetain F, Degano B, Bouhaddi M, Dumoulin G, Vernerey D, Pivot X, Mougin F. A phase 2 randomized trial to evaluate the impact of a supervised exercise program on cardiotoxicity at 3 months in patients with HER2 overexpressing breast cancer undergoing adjuvant treatment by trastuzumab: design of the CARDAPAC study. BMC Cancer. 2017 Jun 19;17(1):425. doi: 10.1186/s12885-017-3420-4.

  PMID: 28629338 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Nathalie Meneveau

  University Hospital of Besançon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: May 4, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

FR (1)