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

Breast Cancer Clinical Trial

— PASAPAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331772
• Other study ID #: PASAPAS
• Secondary ID: 2011-A00064-37
• Status: Completed
• Phase: N/A
• First received: April 4, 2011
• Last updated: October 29, 2014
• Start date: July 2011
• Est. completion date: July 2014

Study information

• Verified date: October 2014
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Adequate Physical Condition
• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Control arm
Dietetic follow-up only
• Intervention arm
Dietetic follow up + adapted physical activity

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon Cedex 08

Sponsors (8)

Lead Sponsor	Collaborator
Centre Leon Berard	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

Country where clinical trial is conducted

France, 

References & Publications (5)

Holmes MD, Chen WY, Feskanich D, Kroenke CH, Colditz GA. Physical activity and survival after breast cancer diagnosis. JAMA. 2005 May 25;293(20):2479-86. — View Citation

Majed B, Moreau T, Senouci K, Salmon RJ, Fourquet A, Asselain B. Is obesity an independent prognosis factor in woman breast cancer? Breast Cancer Res Treat. 2008 Sep;111(2):329-42. Epub 2007 Oct 16. — View Citation

Newton RU, Galvão DA. Exercise in prevention and management of cancer. Curr Treat Options Oncol. 2008 Jun;9(2-3):135-46. doi: 10.1007/s11864-008-0065-1. Epub 2008 Aug 13. Review. — View Citation

Pierce JP, Stefanick ML, Flatt SW, Natarajan L, Sternfeld B, Madlensky L, Al-Delaimy WK, Thomson CA, Kealey S, Hajek R, Parker BA, Newman VA, Caan B, Rock CL. Greater survival after breast cancer in physically active women with high vegetable-fruit intake — View Citation

Trédan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Pérol D, Bachmann P. Body weight change in women receiving adjuvant chemotherapy for breast cancer: a French prospective study. Clin Nutr. 2010 Ap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	No
Secondary	Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance	Rate of patients who completed the full program and analysis of non-compliance grounds during the program	6 months	No
Secondary	Assessment of acceptability of the intervention and randomization / recruiting capabilities	Number of patients contacted by the investigator to participate in the study and rate of patients randomized	6 months	No
Secondary	Verification of adequacy between the conduct procedures of program (APA and dietetic) and the constraints of program implementing in real conditions	Formalization of a program used in real conditions	12 months	No
Secondary	Description of patient satisfaction	Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction	Month 12	No
Secondary	Medico-economic impact of the intervention	Settlement expenses costs, incurred costs and costs avoided by the intervention	12 months	No
Secondary	Biological study	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	No
Secondary	Description of dietary	Collection of patient nutritional intake during 3 days by self-administered questionnaire	Day 1 CT, week 24, month 12	No
Secondary	Description of level and pattern physical activity	Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire)	Day 1 CT, Week 9, Week 24, Month 12	No
Secondary	Description of anthropometry	Measurement of weight, height, waist and hip circumference	Day 1 CT, week 9, week 24, month 12	No
Secondary	Description of lipid profiles	Measurement of total cholesterol, HDL, LDL and triglycerides	Day 1 CT, week 9, week 24, month 12	No
Secondary	Assessment of life quality	Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)	Day 1 CT, week 24, month 12	No
Secondary	Description of anxiety	score calculation of anxiety (STAI questionnaire)	Day 1 CT, week 24, month 12	No
Secondary	Assessment of patients compliance to the implementation of diet and analyze of the reasons for noncompliance	Rate of patients who completed the full program and analysis of non-compliance grounds during the program	6 months	No
Secondary	Description of body satisfaction	score calculation of QSCPGS questionnaire	Day 1 CT, week 24, month 12	No
Secondary	Description of body composition	Measurement of body composition by impedancemetry	Day 1 CT, week 9, week 24, month 12	No
Secondary	Description of self-perception	score calculation of self-perception (QSCPGS questionnaire)	Day 1 CT, week 24, month 12	No
Secondary	Description of self esteem	score calculation of self-esteem (Rosenzweig scale)	Day 1 CT, week 24, month 12	No
Secondary	Description of depression	score calculation of depression (BDI questionnaire)	Day 1 CT, week 24, month 12	No