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Completed

NCT Number: NCT01331772

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Leon Berard

Lyon, 69373, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Arm

Other

Dietetic follow-up only

Intervention Arm

Other

Dietetic follow up + adapted physical activity

Other names: APA arm

Primary outcomes

  1. 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

    Time frame: 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

Secondary outcomes

  1. Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance

    Time frame: 6 months

    Rate of patients who completed the full program and analysis of non-compliance grounds during the program

  2. Assessment of acceptability of the intervention and randomization / recruiting capabilities

    Time frame: 6 months

    Number of patients contacted by the investigator to participate in the study and rate of patients randomized

  3. Verification of adequacy between the conduct procedures of program (APA and dietetic) and the constraints of program implementing in real conditions

    Time frame: 12 months

    Formalization of a program used in real conditions

  4. Description of patient satisfaction

    Time frame: Month 12

    Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction

  5. Medico-economic impact of the intervention

    Time frame: 12 months

    Settlement expenses costs, incurred costs and costs avoided by the intervention

  6. Biological study

    Time frame: 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

  7. Description of dietary

    Time frame: Day 1 CT, week 24, month 12

    Collection of patient nutritional intake during 3 days by self-administered questionnaire

  8. Description of level and pattern physical activity

    Time frame: Day 1 CT, Week 9, Week 24, Month 12

    Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire)

  9. Description of anthropometry

    Time frame: Day 1 CT, week 9, week 24, month 12

    Measurement of weight, height, waist and hip circumference

  10. Description of lipid profiles

    Time frame: Day 1 CT, week 9, week 24, month 12

    Measurement of total cholesterol, HDL, LDL and triglycerides

  11. Assessment of life quality

    Time frame: Day 1 CT, week 24, month 12

    Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)

  12. Description of anxiety

    Time frame: Day 1 CT, week 24, month 12

    score calculation of anxiety (STAI questionnaire)

  13. Assessment of patients compliance to the implementation of diet and analyze of the reasons for noncompliance

    Time frame: 6 months

    Rate of patients who completed the full program and analysis of non-compliance grounds during the program

  14. Description of body satisfaction

    Time frame: Day 1 CT, week 24, month 12

    score calculation of QSCPGS questionnaire

  15. Description of body composition

    Time frame: Day 1 CT, week 9, week 24, month 12

    Measurement of body composition by impedancemetry

  16. Description of self-perception

    Time frame: Day 1 CT, week 24, month 12

    score calculation of self-perception (QSCPGS questionnaire)

  17. Description of self esteem

    Time frame: Day 1 CT, week 24, month 12

    score calculation of self-esteem (Rosenzweig scale)

  18. Description of depression

    Time frame: Day 1 CT, week 24, month 12

    score calculation of depression (BDI questionnaire)

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

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

Registry information

Official study title

Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

Acronym: PASAPAS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2011
Registry last updated
Oct 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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