Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer

NCT01322412 | Completed

• 1 other identifier: I10 009 / SAPA
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. 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 chemotherapy.

Conditions

Breast Cancer

Keywords

Adapted physical activity; breast cancer

Outcome Measures

Primary Outcomes (1)

• main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme

  27 weeks

Secondary Outcomes (1)

• Assessment at 27 and 54 weeks between the 2 groups of muscle function.

  54 weeks

Study Arms (2)

Arm A : physical activity program

Arm A : physical activity program (aerobic and strength training) during the 27 weeks of treatment (chemotherapy and radiotherapy) and conventional follow-up during 27 weeks

Arm B : conventional management

Arm B : conventional management during and after treatment

Eligibility Criteria

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

Study Population

adjuvant breast cancer

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 who have undergone curative surgery
• patients for whom a 6-treatment course of adjuvant chemotherapy (3FEC100 + taxanes) and radiotherapy has been scheduled
• patients with HER2-negative cancer.

You may not qualify if:

• metastatic cancer
• other primary tumours
• disability preventing a proper understanding of the instructions for the trial
• chemotherapy strictly contra-indicated
• 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)

Limoges University Hospital

Limoges, 87042, France

Location

Related Publications (1)

• Cornette T, Vincent F, Mandigout S, Antonini MT, Leobon S, Labrunie A, Venat L, Lavau-Denes S, Tubiana-Mathieu N. Effects of home-based exercise training on VO2 in breast cancer patients under adjuvant or neoadjuvant chemotherapy (SAPA): a randomized controlled trial. Eur J Phys Rehabil Med. 2016 Apr;52(2):223-32. Epub 2015 May 19.

  PMID: 25986222 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Vincent FRANCOIS, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 24, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 21, 2018

Record last verified: 2011-03

Locations

FR (1)