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

• 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)

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.

• Experimental: Intervention arm
  Intervention: Behavioral: Tailored program of PA and nutritional counseling
• No Intervention: Control arm
  Routine practice

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