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

29. Oktober 2014 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

      • Lyon Cedex 08, Frankreich, 69373
        • Centre Léon Bérard

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Sonstiges: Control arm
Dietetic follow-up only
Dietetic follow-up only
Experimental: Intervention arm
Dietetic + adapted physical activity
Dietetic follow up + adapted physical activity
Andere Namen:
  • APA arm

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 12 months
Formalization of a program used in real conditions
12 months
Description of patient satisfaction
Zeitfenster: 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
Zeitfenster: 12 months
Settlement expenses costs, incurred costs and costs avoided by the intervention
12 months
Biological study
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 1 CT, week 24, month 12
score calculation of QSCPGS questionnaire
Day 1 CT, week 24, month 12
Description of body composition
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 1 CT, week 24, month 12
score calculation of self-esteem (Rosenzweig scale)
Day 1 CT, week 24, month 12
Description of depression
Zeitfenster: Day 1 CT, week 24, month 12
score calculation of depression (BDI questionnaire)
Day 1 CT, week 24, month 12

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2011

Primärer Abschluss (Tatsächlich)

1. Juli 2014

Studienabschluss (Tatsächlich)

1. Juli 2014

Studienanmeldedaten

Zuerst eingereicht

4. April 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. April 2011

Zuerst gepostet (Schätzen)

8. April 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

30. Oktober 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

29. Oktober 2014

Zuletzt verifiziert

1. Oktober 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • PASAPAS
  • 2011-A00064-37 (Andere Kennung: AFSSAPS)

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