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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.


Phase 3
18 Years
76 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Subjective fatigue

Outcome Description:

Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire

Outcome Time Frame:

At 18 months

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

APAD

NCT ID:

NCT01495650

Start Date:

December 2010

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • Comprehensive Adjuvant Care
  • Cancer-related fatigue
  • Therapeutic patient education
  • Physical Activity
  • Nutritional counselling
  • Rehabilitation
  • Breast Neoplasms
  • Fatigue

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