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

Breast Cancer Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495650
• Other study ID #: APAD
• Secondary ID: 2010-A00906-33
• Status: Completed
• Phase: Phase 3
• First received: December 15, 2011
• Last updated: August 16, 2017
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2017
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

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).

Locations

Country	Name	City	State
France	CRLC Val d'Aurelle-Paul Lamarque	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective fatigue	Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire	At 18 months
Secondary	Quality of life	Quality of life is measured by the EORTC QLC-C30 questionnaire	At 18 months
Secondary	Anxiety/depressive symptoms	Anxiety/depressive symptoms is measured by the HADS questionnaire	At 18 months
Secondary	Physical activity level	Physical activity level is measured by the GPAQ questionnaire	At 18 months
Secondary	Muscular fatigue	Muscular fatigue is measured by Myotest	At 18 months
Secondary	Attention fatigue	Attention fatigue is measured usingt the TAP 2.2 software	At 18 months
Secondary	Body Mass Index	Body Mass Index is calculated using bodyweight and length measurements	At 18 months
Secondary	Body composition	Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)	At 18 months