- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01331772
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Lyon Cedex 08, Frankrike, 69373
- Centre LEON BERARD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Annen: Control arm
Dietetic follow-up only
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Dietetic follow-up only
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Eksperimentell: Intervention arm
Dietetic + adapted physical activity
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Dietetic follow up + adapted physical activity
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
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
Tidsramme: 6 months
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance
Tidsramme: 6 months
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 6 months
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Patrick BACHMANN, MD, Centre LEON BERARD
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PASAPAS
- 2011-A00064-37 (Annen identifikator: AFSSAPS)
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