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Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment (APAD)

This study is currently recruiting participants.
Verified December 2011 by Centre Val d'Aurelle - Paul Lamarque
Sponsor:
Information provided by (Responsible Party):
Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:
NCT01495650
First received: December 15, 2011
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  Purpose

Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.


Condition Intervention Phase
Breast Cancer
 Behavioral: Tailored program of PA and nutritional counseling
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Controlled Trial to Evaluate the Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving Adjuvant Treatment.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:
  • Subjective fatigue [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire


Secondary Outcome Measures:
  • Quality of life [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Quality of life is measured by the EORTC QLC-C30 questionnaire

  • Anxiety/depressive symptoms [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Anxiety/depressive symptoms is measured by the HADS questionnaire

  • Physical activity level [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Physical activity level is measured by the GPAQ questionnaire

  • Muscular fatigue [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Muscular fatigue is measured by Myotest

  • Attention fatigue [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Attention fatigue is measured usingt the TAP 2.2 software

  • Body Mass Index [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Body Mass Index is calculated using bodyweight and length measurements

  • Body composition [ Time Frame: At 18 months ] [ Designated as safety issue: No ]
    Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)


Estimated Enrollment: 240
Study Start Date: December 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention arm Behavioral: Tailored program of PA and nutritional counseling
Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).
No Intervention: Control arm
Routine practice

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patient with histologically proven breast cancer
  • 18-76 years old
  • Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + taxanes) followed by radiotherapy
  • Satisfactory healing of breast and lymph nodes area
  • Ability to understand the nature, goal and study methodology
  • Consent to cooperate for clinical assessments
  • Affiliation to a social security regime or beneficiary of equivalent social protection
  • Written informed consent provided before any study specific procedures

Exclusion Criteria:

  • HER2 positive or metastatic cancer
  • Any other primary tumor
  • Contraindication to moderate physical activity
  • Contraindication to adjuvant chemotherapy or radiotherapy
  • Pregnancy or breast feeding
  • Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495650

Contacts
Contact: Jean-Pierre Bleuse, MD + 33 4 67 61 23 44 Jean-Pierre.Bleuse@montpellier.unicancer.fr

Locations
France
CRLC Val d'Aurelle-Paul Lamarque Recruiting
Montpellier, France, 34298
Contact: Jean-Pierre Bleuse, MD     +33 4 67 61 23 44     Jean-Pierre.Bleuse@montpellier.unicancer.fr    
Principal Investigator: Gilles Romieu, MD            
Sponsors and Collaborators
Centre Val d'Aurelle - Paul Lamarque
  More Information

No publications provided

Responsible Party: Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier: NCT01495650     History of Changes
Other Study ID Numbers: APAD, 2010-A00906-33
Study First Received: December 15, 2011
Last Updated: December 19, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Val d'Aurelle - Paul Lamarque:
Comprehensive Adjuvant Care
Cancer-related fatigue
Therapeutic patient education
 Physical Activity
Nutritional counselling
Rehabilitation

Additional relevant MeSH terms:
Breast Neoplasms
Fatigue
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Signs and Symptoms
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013