Clinical trial · Interventional
Effect of a Program of Physical Activity and Nutritional Therapeutic Education in Breast Cancer Patients
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
NCT04109326CI-TRIAL-00040902APAD2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APAD | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adapted Physical Activity and Dietetique
- description
- tailored PA program associated with individual nutritional counseling whilst hospitalization and at home during the 26-week duration of adjuvant treatment
- interventionNames
- Other: APAD
- type
- NO_INTERVENTION
- label
- Control
- description
- Standard of care
Primary outcomes (1)
- measure
- Rate of cancer-related fatigue
- timeFrame
- 6 months
- description
- The primary assessment criterion is subjective fatigue measured using the 'General Fatigue' subscale of the Multidimensional Fatigue Inventory (MFI-20) questionnaire.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.