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

Institut du Cancer de Montpellier - Val d'Aurelle

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Behavioral: Tailored program of PA and nutritional counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01495650

2010-A00906-33 (Registry Identifier)

APAD

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 patients

Sex: Female

Ages: 18 to 76 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups

Intervention arm

Experimental group

Treatment:

Behavioral: Tailored program of PA and nutritional counseling

Control arm

No Intervention group

Description:

Routine practice