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

NCT01795612 | Completed

• 1 other identifier: I12007
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test

  unit of measure:ml/kg/min

  at 12 months

Secondary Outcomes (1)

• Exercise tolerance at 12 months (group A vs B)

  at 12 months

Study Arms (3)

Arm A

OTHER

6-month ETP, during adjuvant or neoadjuvant therapy

Other: physical activity

Arm B

OTHER

6-month ETP, after adjuvant or neoadjuvant therapy

Other: physical activity

Arm C

OTHER

12-monthETP, during and after adjuvant or neoadjuvant treatment

Other: physical activity

Interventions

physical activity OTHER

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

University Hospital, Limoges

Limoges, 87042, France

Location

Related Publications (1)

• 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.

  PMID: 33228382 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2013
• First Posted: February 20, 2013
• Study Start: March 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: December 1, 2017
• Last Updated: January 15, 2019

Record last verified: 2015-09

Locations

FR (1)