Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy (PASAPAS)
Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
With approximately 52,600 new cases diagnosed in France in 2010, breast cancer is the most common cancer in women, according to national projections of the incidence and cancer mortality for 2010.
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).
Several hypotheses explain the association between obesity and breast cancer: obesity, metabolic syndrome and diabetes participate to changes in hormone levels (estrogen, leptin, insulin) that promotes mammary carcinogenesis and tumor progression.
The association between obesity and development of breast cancer is partly due to increased serum levels of estradiol produced by adipocytes, but the role of insulin resistance and inflammation associated with obesity is widely discussed.
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. Thus, several large cohort studies of women with breast cancer showed an average mortality reduction of 45% associated with moderate physical activity compared with inactivity. Adapted Physical Activity (APA) could also improve fitness, quality of life, body image, treatment compliance and reduce fatigue.
A rich fruits and vegetables diet combined with regular physical activity appears to offer the best protection from breast cancer. The nature, frequency, duration, intensity and arrangement of physical training program meetings are key elements to consider, metabolic responses differ according to these factors.
The optimal management for an improved level of physical activity appear to be an individual of at least three sessions per week, 30 to 60 minutes each with a moderate intensity, allowing a physiological response to chronic exercise and an adequate recovery.
After diagnosis of breast cancer, there is thus 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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lyon Cedex 08, Francia, 69373
- Centre Léon Bérard
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Control arm
Dietetic follow-up only
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Dietetic follow-up only
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Experimental: Intervention arm
Dietetic + adapted physical activity
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Dietetic follow up + adapted physical activity
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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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
Periodo de tiempo: 6 months
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Proportion of patients who participate in at least two mandatory APA sessions by week during all the APA program, except during the 1st week of each course of CT
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance
Periodo de tiempo: 6 months
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Rate of patients who completed the full program and analysis of non-compliance grounds during the program
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6 months
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Assessment of acceptability of the intervention and randomization / recruiting capabilities
Periodo de tiempo: 6 months
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Number of patients contacted by the investigator to participate in the study and rate of patients randomized
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6 months
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Verification of adequacy between the conduct procedures of program (APA and dietetic) and the constraints of program implementing in real conditions
Periodo de tiempo: 12 months
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Formalization of a program used in real conditions
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12 months
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Description of patient satisfaction
Periodo de tiempo: Month 12
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Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction
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Month 12
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Medico-economic impact of the intervention
Periodo de tiempo: 12 months
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Settlement expenses costs, incurred costs and costs avoided by the intervention
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12 months
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Biological study
Periodo de tiempo: Day 1 CT, week 9, week 24, month 12
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Analyses of metabolomic profiles and adipokines expression linked to breast cancer at initial diagnosis (before surgery) and description of metabolism changes during nutritional interventions and therapeutic care
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Day 1 CT, week 9, week 24, month 12
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Description of dietary
Periodo de tiempo: Day 1 CT, week 24, month 12
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Collection of patient nutritional intake during 3 days by self-administered questionnaire
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Day 1 CT, week 24, month 12
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Description of level and pattern physical activity
Periodo de tiempo: Day 1 CT, Week 9, Week 24, Month 12
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Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire)
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Day 1 CT, Week 9, Week 24, Month 12
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Description of anthropometry
Periodo de tiempo: Day 1 CT, week 9, week 24, month 12
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Measurement of weight, height, waist and hip circumference
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Day 1 CT, week 9, week 24, month 12
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Description of lipid profiles
Periodo de tiempo: Day 1 CT, week 9, week 24, month 12
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Measurement of total cholesterol, HDL, LDL and triglycerides
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Day 1 CT, week 9, week 24, month 12
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Assessment of life quality
Periodo de tiempo: Day 1 CT, week 24, month 12
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Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)
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Day 1 CT, week 24, month 12
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Description of anxiety
Periodo de tiempo: Day 1 CT, week 24, month 12
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score calculation of anxiety (STAI questionnaire)
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Day 1 CT, week 24, month 12
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Assessment of patients compliance to the implementation of diet and analyze of the reasons for noncompliance
Periodo de tiempo: 6 months
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Rate of patients who completed the full program and analysis of non-compliance grounds during the program
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6 months
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Description of body satisfaction
Periodo de tiempo: Day 1 CT, week 24, month 12
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score calculation of QSCPGS questionnaire
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Day 1 CT, week 24, month 12
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Description of body composition
Periodo de tiempo: Day 1 CT, week 9, week 24, month 12
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Measurement of body composition by impedancemetry
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Day 1 CT, week 9, week 24, month 12
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Description of self-perception
Periodo de tiempo: Day 1 CT, week 24, month 12
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score calculation of self-perception (QSCPGS questionnaire)
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Day 1 CT, week 24, month 12
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Description of self esteem
Periodo de tiempo: Day 1 CT, week 24, month 12
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score calculation of self-esteem (Rosenzweig scale)
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Day 1 CT, week 24, month 12
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Description of depression
Periodo de tiempo: Day 1 CT, week 24, month 12
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score calculation of depression (BDI questionnaire)
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Day 1 CT, week 24, month 12
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Patrick BACHMANN, MD, Centre Léon Bérard
Publicaciones y enlaces útiles
Publicaciones Generales
- Pierce 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.
- Holmes 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.
- Majed 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.
- Tredan 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.
- Newton 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.
- Febvey-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.
- Perrier L, Foucaut AM, Morelle M, Touillaud M, Kempf-Lepine AS, Heinz D, Gomez F, Meyrand R, Baudinet C, Berthouze S, Reynes E, Carretier J, Guillemaut S, Perol D, Tredan O, Philip T, Bachmann P, Fervers B. Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2829-2842. doi: 10.1007/s00520-019-05078-4. Epub 2019 Nov 15.
- Foucaut AM, Morelle M, Kempf-Lepine AS, Baudinet C, Meyrand R, Guillemaut S, Metzger S, Bourne-Branchu V, Grinand E, Chabaud S, Perol D, Carretier J, Berthouze SE, Reynes E, Perrier L, Rebattu P, Heudel PE, Bachelot T, Bachmann P, Fervers B, Tredan O, Touillaud M. Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2019 Sep;27(9):3449-3461. doi: 10.1007/s00520-019-4658-y. Epub 2019 Jan 24.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PASAPAS
- 2011-A00064-37 (Otro identificador: AFSSAPS)
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