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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute, France
Ligue du Rhône
Fondation de France
CLARA
Lions Club Bourg-en-Bresse et Pérouges
Association Lyonnaise de Logistique Posthospitalière
Ministère de la Recherche
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01331772
First received: April 4, 2011
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Adequate Physical Condition
Other: Control arm
Other: Intervention arm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rate of patients who completed the full program and analysis of non-compliance grounds during the program

  • Assessment of acceptability of the intervention and randomization / recruiting capabilities [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Number of patients contacted by the investigator to participate in the study and rate of patients randomized

  • 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 ] [ Designated as safety issue: No ]
    Formalization of a program used in real conditions

  • Description of patient satisfaction [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction

  • Medico-economic impact of the intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Settlement expenses costs, incurred costs and costs avoided by the intervention

  • Biological study [ Time Frame: Day 1 CT, week 9, week 24, month 12 ] [ Designated as safety issue: No ]
    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

  • Description of dietary [ Time Frame: Day 1 CT, week 24, month 12 ] [ Designated as safety issue: No ]
    Collection of patient nutritional intake during 3 days by self-administered questionnaire

  • Description of level and pattern physical activity [ Time Frame: Day 1 CT, Week 9, Week 24, Month 12 ] [ Designated as safety issue: No ]
    Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire)

  • Description of anthropometry [ Time Frame: Day 1 CT, week 9, week 24, month 12 ] [ Designated as safety issue: No ]
    Measurement of weight, height, waist and hip circumference

  • Description of lipid profiles [ Time Frame: Day 1 CT, week 9, week 24, month 12 ] [ Designated as safety issue: No ]
    Measurement of total cholesterol, HDL, LDL and triglycerides

  • Assessment of life quality [ Time Frame: Day 1 CT, week 24, month 12 ] [ Designated as safety issue: No ]
    Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)

  • Description of anxiety [ Time Frame: Day 1 CT, week 24, month 12 ] [ Designated as safety issue: No ]
    score calculation of anxiety (STAI questionnaire)

  • Assessment of patients compliance to the implementation of diet and analyze of the reasons for noncompliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rate of patients who completed the full program and analysis of non-compliance grounds during the program

  • Description of body satisfaction [ Time Frame: Day 1 CT, week 24, month 12 ] [ Designated as safety issue: No ]
    score calculation of QSCPGS questionnaire

  • Description of body composition [ Time Frame: Day 1 CT, week 9, week 24, month 12 ] [ Designated as safety issue: No ]
    Measurement of body composition by impedancemetry

  • Description of self-perception [ Time Frame: Day 1 CT, week 24, month 12 ] [ Designated as safety issue: No ]
    score calculation of self-perception (QSCPGS questionnaire)

  • Description of self esteem [ Time Frame: Day 1 CT, week 24, month 12 ] [ Designated as safety issue: No ]
    score calculation of self-esteem (Rosenzweig scale)

  • Description of depression [ Time Frame: Day 1 CT, week 24, month 12 ] [ Designated as safety issue: No ]
    score calculation of depression (BDI questionnaire)


Estimated Enrollment: 60
Study Start Date: July 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control arm
Dietetic follow-up only
Other: Control arm
Dietetic follow-up only
Experimental: Intervention arm
Dietetic + adapted physical activity
Other: Intervention arm
Dietetic follow up + adapted physical activity
Other Name: APA arm

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331772

Locations
France
Centre Leon Berard
Lyon Cedex 08, France, 69373
Sponsors and Collaborators
Centre Leon Berard
National Cancer Institute, France
Ligue du Rhône
Fondation de France
CLARA
Lions Club Bourg-en-Bresse et Pérouges
Association Lyonnaise de Logistique Posthospitalière
Ministère de la Recherche
Investigators
Principal Investigator: Patrick BACHMANN, MD Centre Leon Berard
  More Information

Publications:
Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01331772     History of Changes
Other Study ID Numbers: PASAPAS, 2011-A00064-37
Study First Received: April 4, 2011
Last Updated: October 29, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Leon Berard:
Breast cancer
Adapted Physical activity
Nutrition
Assessment
Patient education

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 29, 2014