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NCT Number: NCT04109326

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Sainte Catherine, Avignon, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APAD

Other

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.

Primary outcomes

  1. Rate of cancer-related fatigue

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study 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

Acronym: APAD2

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2019
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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