Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase

NCT ID: NCT01795612

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2017-12-31

Brief Summary

Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. It contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. Cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant or néoadjuvant chemotherapy.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm A

6-month ETP, during adjuvant or neoadjuvant therapy

Group Type: OTHER

physical activity

Intervention Type: OTHER

Arm B

6-month ETP, after adjuvant or neoadjuvant therapy

Group Type: OTHER

physical activity

Intervention Type: OTHER

Arm C

12-monthETP, during and after adjuvant or neoadjuvant treatment

Group Type: OTHER

physical activity

Intervention Type: OTHER

Interventions

physical activity

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• females between 18 and 75 years of age;
• signed written informed consent;
• willing to take part in the trial and to follow the instructions;
• breast tumour, histologically documented;
• patients for whom a 6-treatment course of adjuvant or neoadjuvant chemotherapy (3FEC100 +3 taxanes or 6 FEC) +/- radiotherapy+/- Herceptin has been scheduled;

Exclusion Criteria

• metastatic cancer;
• disability preventing a proper understanding of the instructions for the trial;
• patients who are subject to a court protection, wardship or guardianship order;
• uncontrolled hypertension;
• family history of sudden death in a first-degree relative;
• unstabilised heart disease;
• current treatment with beta-blockers;
• chronic or acute pulmonary disease associated with dyspnoea upon moderate effort;
• uncontrolled thyroid dysfunction;
• uncontrolled diabetes;
• any other serious conditions that are unstabilised,
• disabling or in which physical exercise is contra-indicated;
• unable to attend for follow-up throughout the duration of the study;
• ventricular ejection fraction (VEF) < 50%, pregnancy or suckling.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital, Limoges

Limoges, , France

Countries

France

References

Vincent F, Deluche E, Bonis J, Leobon S, Antonini MT, Laval C, Favard F, Dobbels E, Lavau-Denes S, Labrunie A, Thuillier F, Venat L, Tubiana-Mathieu N. Home-Based Physical Activity in Patients With Breast Cancer: During and/or After Chemotherapy? Impact on Cardiorespiratory Fitness. A 3-Arm Randomized Controlled Trial (APAC). Integr Cancer Ther. 2020 Jan-Dec;19:1534735420969818. doi: 10.1177/1534735420969818.

Reference Type: DERIVED

PMID: 33228382 (View on PubMed)

Other Identifiers

I12007

Identifier Type: -

Identifier Source: org_study_id