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Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy (PASAPAS)

29. oktober 2014 oppdatert av: Centre Leon Berard

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

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

Intervensjonell

Registrering (Forventet)

60

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Lyon Cedex 08, Frankrike, 69373
        • Centre LEON BERARD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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
Dietetic follow-up only
Eksperimentell: Intervention arm
Dietetic + adapted physical activity
Dietetic follow up + adapted physical activity
Andre navn:
  • APA arm

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
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
6 months
Assessment of acceptability of the intervention and randomization / recruiting capabilities
Tidsramme: 6 months
Number of patients contacted by the investigator to participate in the study and rate of patients randomized
6 months
Verification of adequacy between the conduct procedures of program (APA and dietetic) and the constraints of program implementing in real conditions
Tidsramme: 12 months
Formalization of a program used in real conditions
12 months
Description of patient satisfaction
Tidsramme: Month 12
Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction
Month 12
Medico-economic impact of the intervention
Tidsramme: 12 months
Settlement expenses costs, incurred costs and costs avoided by the intervention
12 months
Biological study
Tidsramme: Day 1 CT, week 9, week 24, month 12
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
Day 1 CT, week 9, week 24, month 12
Description of dietary
Tidsramme: Day 1 CT, week 24, month 12
Collection of patient nutritional intake during 3 days by self-administered questionnaire
Day 1 CT, week 24, month 12
Description of level and pattern physical activity
Tidsramme: Day 1 CT, Week 9, Week 24, Month 12
Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire)
Day 1 CT, Week 9, Week 24, Month 12
Description of anthropometry
Tidsramme: Day 1 CT, week 9, week 24, month 12
Measurement of weight, height, waist and hip circumference
Day 1 CT, week 9, week 24, month 12
Description of lipid profiles
Tidsramme: Day 1 CT, week 9, week 24, month 12
Measurement of total cholesterol, HDL, LDL and triglycerides
Day 1 CT, week 9, week 24, month 12
Assessment of life quality
Tidsramme: Day 1 CT, week 24, month 12
Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)
Day 1 CT, week 24, month 12
Description of anxiety
Tidsramme: Day 1 CT, week 24, month 12
score calculation of anxiety (STAI questionnaire)
Day 1 CT, week 24, month 12
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
6 months
Description of body satisfaction
Tidsramme: Day 1 CT, week 24, month 12
score calculation of QSCPGS questionnaire
Day 1 CT, week 24, month 12
Description of body composition
Tidsramme: Day 1 CT, week 9, week 24, month 12
Measurement of body composition by impedancemetry
Day 1 CT, week 9, week 24, month 12
Description of self-perception
Tidsramme: Day 1 CT, week 24, month 12
score calculation of self-perception (QSCPGS questionnaire)
Day 1 CT, week 24, month 12
Description of self esteem
Tidsramme: Day 1 CT, week 24, month 12
score calculation of self-esteem (Rosenzweig scale)
Day 1 CT, week 24, month 12
Description of depression
Tidsramme: Day 1 CT, week 24, month 12
score calculation of depression (BDI questionnaire)
Day 1 CT, week 24, month 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juli 2011

Primær fullføring (Faktiske)

1. juli 2014

Studiet fullført (Faktiske)

1. juli 2014

Datoer for studieregistrering

Først innsendt

4. april 2011

Først innsendt som oppfylte QC-kriteriene

7. april 2011

Først lagt ut (Anslag)

8. april 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

30. oktober 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. oktober 2014

Sist bekreftet

1. oktober 2014

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • PASAPAS
  • 2011-A00064-37 (Annen identifikator: AFSSAPS)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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