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

29 октября 2014 г. обновлено: 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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Ожидаемый)

60

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 75 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Женский

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Другой: Control arm
Dietetic follow-up only
Другой: Control arm
Dietetic follow-up only
Экспериментальный: Intervention arm
Dietetic + adapted physical activity
Другой: Intervention arm
Dietetic follow up + adapted physical activity
Другие имена:
  • APA arm

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: 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

Вторичные показатели результатов

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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Centre Leon Berard

Соавторы

National Cancer Institute, France
Fondation de France
Cancéropôle Lyon Auvergne Rhône-Alpes
Association Lyonnaise de Logistique Posthospitalière
Ligue du Rhône
Lions Club Bourg-en-Bresse et Pérouges
Ministère de la Recherche

Следователи

  • Главный следователь: Patrick BACHMANN, MD, Centre Léon Bérard

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования

1 июля 2011 г.

Первичное завершение (Действительный)

1 июля 2014 г.

Завершение исследования (Действительный)

1 июля 2014 г.

Даты регистрации исследования

Первый отправленный

4 апреля 2011 г.

Впервые представлено, что соответствует критериям контроля качества

7 апреля 2011 г.

Первый опубликованный (Оценивать)

8 апреля 2011 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

30 октября 2014 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 октября 2014 г.

Последняя проверка

1 октября 2014 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • PASAPAS
  • 2011-A00064-37 (Другой идентификатор: AFSSAPS)

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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