Clinical trial · Interventional
Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy
Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy
- 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)
Breast cancer is the most common cancer in women. Weight gain in adulthood, overweight or obesity, physical inactivity and alcohol consumption are risk factors commonly associated with risk of breast cancer (mainly for post-menopausal for overweight and obesity). Reduced physical activity is one factor likely to weight gain in women after adjuvant chemotherapy for localized breast cancer. Furthermore, physical activity appropriately could improve many prognostic factors and survival of women after breast cancer. Adapted Physical Activity (APA) could improve fitness, quality of life, body image, treatment compliance and reduce fatigue. After diagnosis of breast cancer, there is many possible risk factors of mortality or morbidity related to nutritional factors available to management. These risks prevention through management of these patients appears indispensable through an APA program. Thus, the investigators propose to test the feasibility of implementing a program of dietary intervention and APA to prevent the risk of weight gain (which affects more than half of patients) and maintain and/or increase their level of physical activity during and after adjuvant chemotherapy.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adequate Physical Condition | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control arm | Other | — | UNRESOLVED |
| Intervention arm | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Control arm
- description
- Dietetic follow-up only
- interventionNames
- Other: Control arm
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- Dietetic + adapted physical activity
- interventionNames
- Other: Intervention arm
Primary outcomes (1)
- measure
- Assessment in a cohort of adult patients with a 1st breast cancer non-metastatic, the feasibility of implementing an APA intervention during 6 months, in addition to a dietary management, concomitant to prescription of a first-line adjuvant chemotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female, 18 years ≤ age \< 75 years * With an invasive, non-metastatic, histologically confirmed, first breast carcinoma * Requiring the prescription of a first line of adjuvant chemotherapy * Followed in the research center * Whose ability to participate in the APA intervention has been certified by a medical certificate issued by physician, the referring physician or the physician investigator * Residing within a radius of 60 km around the center investigator or agreeing to bear the travel costs beyond proposed reimbursement * Availability and willingness to invest in the PASAPAS study during the program (6 months) and during the post-program follow-up (6 months) * Able to understand, read and write French * Covered by a medical insurance * Written, signed informed consent Exclusion Criteria: * Female with metastatic or inflammatory breast cancer, * History or concomitant primary cancer (except for carcinoma in situ of the uterine cervix and/or skin basal cell carcinoma and or colon carcinoma in situ and/or not a breast cancer in complete response for at least 5 years) * Cons-indication to physical activity practice, at discretion of the investigator, * In a state of severe malnutrition according to the criteria of the High Authority for Health (HAS) 2010, namely: * Among women ≤ 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month * Among women \> 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month, body mass index \< 18 kg / m² * History of eating disorders, * Not possible follow-up for medical, social, familial, geographical or psychological reasons, during the program (6 months) and during the post-program follow-up (6 months), * Deprived of their liberty by court or administrative decision, * Pregnant or nursing, of childbearing age without effective contraception during the study.
References
Publications (8)
- RESULTMajed B, Moreau T, Senouci K, Salmon RJ, Fourquet A, Asselain B. Is obesity an independent prognosis factor in woman breast cancer? Breast Cancer Res Treat. 2008 Sep;111(2):329-42. doi: 10.1007/s10549-007-9785-3. Epub 2007 Oct 16. PMID 17939036
- RESULTTredan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Perol D, Bachmann P. Body weight change in women receiving adjuvant chemotherapy for breast cancer: a French prospective study. Clin Nutr. 2010 Apr;29(2):187-91. doi: 10.1016/j.clnu.2009.08.003. Epub 2009 Aug 26. PMID 19713014
- RESULTHolmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. doi: 10.1001/jama.293.20.2479. PMID 15914748
- RESULTNewton RU, Galvao DA. Exercise in prevention and management of cancer. Curr Treat Options Oncol. 2008 Jun;9(2-3):135-46. doi: 10.1007/s11864-008-0065-1. Epub 2008 Aug 13. PMID 18704691
- RESULTPierce JP, Stefanick ML, Flatt SW, Natarajan L, Sternfeld B, Madlensky L, Al-Delaimy WK, Thomson CA, Kealey S, Hajek R, Parker BA, Newman VA, Caan B, Rock CL. Greater survival after breast cancer in physically active women with high vegetable-fruit intake regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51. doi: 10.1200/JCO.2006.08.6819. PMID 17557947
- DERIVEDFebvey-Combes O, Jobard E, Rossary A, Pialoux V, Foucaut AM, Morelle M, Delrieu L, Martin A, Caldefie-Chezet F, Touillaud M, Berthouze SE, Boumaza H, Elena-Herrmann B, Bachmann P, Tredan O, Vasson MP, Fervers B. Effects of an Exercise and Nutritional Intervention on Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment for Localized Breast Cancer: Results From the PASAPAS Feasibility Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420977666. doi: 10.1177/1534735420977666. PMID 33655799