Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients

Breast Cancer Clinical Trial

— APAD2  

Official title:

Effect of a Tailored Program of Physical Activity and Nutritional Therapeutic Education on Clinical, Psychological and Sociological Factors in Breast Cancer Patients Undergoing Adjuvant Treatment : Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04109326
• Other study ID #: VA2012/39
• Secondary ID: 2012-A01648-35
• Status: Completed
• Phase: N/A
• Start date: May 15, 2013
• Est. completion date: June 11, 2016

Study information

• Verified date: September 2019
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicenter randomized controlled trial aims to evaluate the effect of a tailored program of physical activity and nutritional therapeutic education on clinical, psychological and sociological factors in breast cancer patients undergoing adjuvant treatment.

Description:

The experimental arm "APAD": tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment

The experimental program will include:

• 8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week.

• 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment.

The control arm: standard of care

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 11, 2016
• Est. primary completion date: January 5, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patient with histologically proven breast cancer

• Age =18 years old

• Patients having undergone curative surgery and eligible to 6 cycles of adjuvant chemotherapy (6 FEC100, or 3FEC100 + 3 taxanes) followed by radiotherapy

• Satisfactory healing from surgical act on breast and lymph nodes

• 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:

• Metastatic disease

• Any other primary tumor

• Contra-indication to moderate physical activity: Unchecked high blood pressure; family history of sudden death in a first degree relative; not stabilized heart disease; acute or chronic lung disease resulting in dyspnea for moderate effort; uncontrolled diabetes, carrying a stent; other severe pathologies unstabilized, disabled or not indicated to physical practice.

• Contra-indication to adjuvant chemotherapy or radiotherapy

• Pregnancy or breast feeding (according to the recommendations of the usual adjuvant breast cancer)

• Inability to attend or comply with interventions or follow-up scheduling, disability or difficulty preventing a proper understanding of trial instructions

• Legal inability or restricted legal ability

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• APAD
8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week. 6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment.

Locations

Country	Name	City	State
France	Institut Sainte Catherine	Avignon
France	Centre Oscar Lambret	Lille
France	Centre Léon Bérard	Lyon
France	CH Ambroise Paré	Marseille
France	CH Montélimar	Montélimar
France	ICM	Montpellier
France	Centre Eugène Marquis	Rennes
France	Institut de Cancéologie de l'Ouest	Saint-Herblain

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	Rate of cancer-related fatigue	The primary assessment criterion is subjective fatigue measured using the 'General Fatigue' subscale of the Multidimensional Fatigue Inventory (MFI-20) questionnaire.	6 months