Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment (APAD)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Tailored program of PA and nutritional counseling
Sponsored by

About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Comprehensive Adjuvant Care, Cancer-related fatigue, Therapeutic patient education, Physical Activity, Nutritional counselling, Rehabilitation
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
Sites / Locations
- CRLC Val d'Aurelle-Paul Lamarque
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Control arm
Arm Description
Routine practice
Outcomes
Primary Outcome Measures
Subjective fatigue
Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire
Secondary Outcome Measures
Quality of life
Quality of life is measured by the EORTC QLC-C30 questionnaire
Anxiety/depressive symptoms
Anxiety/depressive symptoms is measured by the HADS questionnaire
Physical activity level
Physical activity level is measured by the GPAQ questionnaire
Muscular fatigue
Muscular fatigue is measured by Myotest
Attention fatigue
Attention fatigue is measured usingt the TAP 2.2 software
Body Mass Index
Body Mass Index is calculated using bodyweight and length measurements
Body composition
Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)
Full Information
NCT ID
NCT01495650
First Posted
December 15, 2011
Last Updated
August 16, 2017
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
1. Study Identification
Unique Protocol Identification Number
NCT01495650
Brief Title
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment
Acronym
APAD
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Comprehensive Adjuvant Care, Cancer-related fatigue, Therapeutic patient education, Physical Activity, Nutritional counselling, Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Routine practice
Intervention Type
Behavioral
Intervention Name(s)
Tailored program of PA and nutritional counseling
Intervention Description
Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).
Primary Outcome Measure Information:
Title
Subjective fatigue
Description
Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire
Time Frame
At 18 months
Secondary Outcome Measure Information:
Title
Quality of life
Description
Quality of life is measured by the EORTC QLC-C30 questionnaire
Time Frame
At 18 months
Title
Anxiety/depressive symptoms
Description
Anxiety/depressive symptoms is measured by the HADS questionnaire
Time Frame
At 18 months
Title
Physical activity level
Description
Physical activity level is measured by the GPAQ questionnaire
Time Frame
At 18 months
Title
Muscular fatigue
Description
Muscular fatigue is measured by Myotest
Time Frame
At 18 months
Title
Attention fatigue
Description
Attention fatigue is measured usingt the TAP 2.2 software
Time Frame
At 18 months
Title
Body Mass Index
Description
Body Mass Index is calculated using bodyweight and length measurements
Time Frame
At 18 months
Title
Body composition
Description
Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)
Time Frame
At 18 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
CRLC Val d'Aurelle-Paul Lamarque
City
Montpellier
ZIP/Postal Code
34298
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31345179
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.
Results Reference
derived
Learn more about this trial
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment
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