Clinical trial NCT01495650: Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Comprehensive Adjuvant Care
Cancer-related fatigue
Therapeutic patient education
Physical Activity
Nutritional counselling
Rehabilitation
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 76
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Subjective fatigue
timeFrame: At 18 months
Secondary outcomes:
measure: Quality of life
timeFrame: At 18 months
measure: Anxiety/depressive symptoms
timeFrame: At 18 months
measure: Physical activity level
timeFrame: At 18 months
measure: Muscular fatigue
timeFrame: At 18 months
measure: Attention fatigue
timeFrame: At 18 months
measure: Body Mass Index
timeFrame: At 18 months
measure: Body composition
timeFrame: At 18 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CRLC Val d'Aurelle-Paul Lamarque
Study officials:
References:
citation: Carayol M, Ninot G, Senesse P, Bleuse JP, Gourgou S, Sancho-Garnier H, Sari C, Romieu I, Romieu G, Jacot W. Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial. BMC Cancer. 2019 Jul 25;19(1):737. doi: 10.1186/s12885-019-5896-6.