Clinical trial · Interventional
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment
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.
- 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)
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.
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 |
|---|---|---|---|
| Tailored program of PA and nutritional counseling | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention arm
- interventionNames
- Behavioral: Tailored program of PA and nutritional counseling
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Routine practice
Primary outcomes (1)
- measure
- Subjective fatigue
- timeFrame
- At 18 months
- description
- Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 76 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDTouraine C, Jacot W, Gourgou S, Carayol M, Senesse P, Ninot G, Mollevi C. Impact of adapted physical activity and diet counselling on health-related quality of life in women undergoing adjuvant breast cancer therapy. Sci Rep. 2025 Mar 10;15(1):8215. doi: 10.1038/s41598-025-91569-w. PMID 40064980
- DERIVEDCarayol M, Ninot G, Senesse P, Bleuse JP, Gourgou S, Sancho-Garnier H, Sari C, Romieu I, Romieu G, Jacot W. Short- and long-term impact of adapted physical activity and diet counseling during adjuvant breast cancer therapy: the "APAD1" randomized controlled trial. BMC Cancer. 2019 Jul 25;19(1):737. doi: 10.1186/s12885-019-5896-6. PMID 31345179