Breast CancerPASAPASNCT01331772
Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy
A study testing Intervention arm in people with Breast Cancer and Adequate Physical Condition, run by Centre Leon Berard at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Adequate Physical Condition
- What is being tested?
- Intervention arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Adequate Physical Condition
- Being tested
- Control arm, Intervention arm
- Keywords
- Breast cancer, Adapted Physical activity, Nutrition, Assessment, Patient education
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control armOther
Dietetic follow-up only
Intervention armOther
Also called APA arm
Dietetic follow up + adapted physical activity
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Other | Dietetic follow-up only Receives: Other: Control arm |
| Intervention arm | Experimental | Dietetic + adapted physical activity Receives: Other: Intervention arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (18)
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
Measured: 6 months
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
Measured: 6 months
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
Measured: 12 months
Description of patient satisfaction
Calculation of overall satisfaction score of patients on the treatment received, evaluated by a scale of satisfaction
Measured: Month 12
Medico-economic impact of the intervention
Settlement expenses costs, incurred costs and costs avoided by the intervention
Measured: 12 months
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
Measured: Day 1 CT, week 9, week 24, month 12
Description of dietary
Collection of patient nutritional intake during 3 days by self-administered questionnaire
Measured: Day 1 CT, week 24, month 12
Description of level and pattern physical activity
Evaluation of level and pattern physical evaluation (PAQAP and IPAQ questionnaire)
Measured: Day 1 CT, Week 9, Week 24, Month 12
Description of anthropometry
Measurement of weight, height, waist and hip circumference
Measured: Day 1 CT, week 9, week 24, month 12
Description of lipid profiles
Measurement of total cholesterol, HDL, LDL and triglycerides
Measured: Day 1 CT, week 9, week 24, month 12
Assessment of life quality
Life quality scores calculation (QLQ-C30, BR-23, MOS SF-36)
Measured: Day 1 CT, week 24, month 12
Description of anxiety
score calculation of anxiety (STAI questionnaire)
Measured: Day 1 CT, week 24, month 12
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
Measured: 6 months
Description of body satisfaction
score calculation of QSCPGS questionnaire
Measured: Day 1 CT, week 24, month 12
Description of body composition
Measurement of body composition by impedancemetry
Measured: Day 1 CT, week 9, week 24, month 12
Description of self-perception
score calculation of self-perception (QSCPGS questionnaire)
Measured: Day 1 CT, week 24, month 12
Description of self esteem
score calculation of self-esteem (Rosenzweig scale)
Measured: Day 1 CT, week 24, month 12
Description of depression
score calculation of depression (BDI questionnaire)
Measured: Day 1 CT, week 24, month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Ligue du Rhône, Fondation de France, Cancéropôle Lyon Auvergne Rhône-Alpes, Lions Club Bourg-en-Bresse et Pérouges, Association Lyonnaise de Logistique Posthospitalière, Ministère de la Recherche
- Responsible party
- Sponsor
- Investigators
- Patrick BACHMANN, MD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331772
- Sponsor's protocol ID
- PASAPAS
- Other IDs
- 2011-A00064-37
- Acronym
- PASAPAS
- Status last verified
- Oct 2014
- First submitted
- 4 Apr 2011
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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. doi: 10.1007/s10549-007-9785-3. Epub 2007 Oct 16.
PubMed 17939036Tredan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Perol D, Bachmann P. Body weight change in women receiving adjuvant chemotherapy for breast cancer: a French prospective study. Clin Nutr. 2010 Apr;29(2):187-91. doi: 10.1016/j.clnu.2009.08.003. Epub 2009 Aug 26.
PubMed 19713014Holmes 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. doi: 10.1001/jama.293.20.2479.
PubMed 15914748Newton RU, Galvao 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.
PubMed 18704691Pierce 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 regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51. doi: 10.1200/JCO.2006.08.6819.
PubMed 17557947Febvey-Combes O, Jobard E, Rossary A, Pialoux V, Foucaut AM, Morelle M, Delrieu L, Martin A, Caldefie-Chezet F, Touillaud M, Berthouze SE, Boumaza H, Elena-Herrmann B, Bachmann P, Tredan O, Vasson MP, Fervers B. Effects of an Exercise and Nutritional Intervention on Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment for Localized Breast Cancer: Results From the PASAPAS Feasibility Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420977666. doi: 10.1177/1534735420977666.
PubMed 33655799Perrier L, Foucaut AM, Morelle M, Touillaud M, Kempf-Lepine AS, Heinz D, Gomez F, Meyrand R, Baudinet C, Berthouze S, Reynes E, Carretier J, Guillemaut S, Perol D, Tredan O, Philip T, Bachmann P, Fervers B. Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2829-2842. doi: 10.1007/s00520-019-05078-4. Epub 2019 Nov 15.
PubMed 31729566Foucaut AM, Morelle M, Kempf-Lepine AS, Baudinet C, Meyrand R, Guillemaut S, Metzger S, Bourne-Branchu V, Grinand E, Chabaud S, Perol D, Carretier J, Berthouze SE, Reynes E, Perrier L, Rebattu P, Heudel PE, Bachelot T, Bachmann P, Fervers B, Tredan O, Touillaud M. Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2019 Sep;27(9):3449-3461. doi: 10.1007/s00520-019-4658-y. Epub 2019 Jan 24.
PubMed 30680617
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Assessing the Feasibility and the Medico-economic Impact of Nutritional Intervention in Women With Breast Cancer Under Adjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT01331772
- Acronym / sponsor ID
- PASAPAS / PASAPAS
- Conditions
- Breast Cancer, Adequate Physical Condition
- Keywords
- Breast cancer, Adapted Physical activity, Nutrition, Assessment, Patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Ligue du Rhône, Fondation de France, Cancéropôle Lyon Auvergne Rhône-Alpes, Lions Club Bourg-en-Bresse et Pérouges, Association Lyonnaise de Logistique Posthospitalière, Ministère de la Recherche
- Study start
- Jul 2011
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control arm | Other | Other: Control armDietetic follow-up only |
| Intervention arm | Experimental | Other: Intervention armDietetic + adapted physical activity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
- History of eating disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control armDietetic follow-up only | Other | Control arm |
| Intervention armAlso: APA armDietetic follow up + adapted physical activity | Other | Intervention arm |
Primary outcome
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
18 secondary outcomes
Assessment of patients compliance to the implementation of the APA program and analyze of the reasons for noncompliance
Time frame: 6 months
Assessment of acceptability of the intervention and randomization / recruiting capabilities
Time frame: 6 months
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
Description of patient satisfaction
Time frame: Month 12
Medico-economic impact of the intervention
Time frame: 12 months
Biological study
Time frame: Day 1 CT, week 9, week 24, month 12
Description of dietary
Time frame: Day 1 CT, week 24, month 12
Description of level and pattern physical activity
Time frame: Day 1 CT, Week 9, Week 24, Month 12
Description of anthropometry
Time frame: Day 1 CT, week 9, week 24, month 12
Description of lipid profiles
Time frame: Day 1 CT, week 9, week 24, month 12
Assessment of life quality
Time frame: Day 1 CT, week 24, month 12
Description of anxiety
Time frame: Day 1 CT, week 24, month 12
Assessment of patients compliance to the implementation of diet and analyze of the reasons for noncompliance
Time frame: 6 months
Description of body satisfaction
Time frame: Day 1 CT, week 24, month 12
Description of body composition
Time frame: Day 1 CT, week 9, week 24, month 12
Description of self-perception
Time frame: Day 1 CT, week 24, month 12
Description of self esteem
Time frame: Day 1 CT, week 24, month 12
Description of depression
Time frame: Day 1 CT, week 24, month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2014.
- Results publication: PubMed 17939036Majed 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. doi: 10.1007/s10549-007-9785-3. Epub 2007 Oct 16.
- Results publication: PubMed 19713014Tredan O, Bajard A, Meunier A, Roux P, Fiorletta I, Gargi T, Bachelot T, Guastalla JP, Lallemand Y, Faure C, Perol D, Bachmann P. Body weight change in women receiving adjuvant chemotherapy for breast cancer: a French prospective study. Clin Nutr. 2010 Apr;29(2):187-91. doi: 10.1016/j.clnu.2009.08.003. Epub 2009 Aug 26.
- Results publication: PubMed 15914748Holmes 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. doi: 10.1001/jama.293.20.2479.
- Results publication: PubMed 18704691Newton RU, Galvao 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.
- Results publication: PubMed 17557947Pierce 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 regardless of obesity. J Clin Oncol. 2007 Jun 10;25(17):2345-51. doi: 10.1200/JCO.2006.08.6819.
- Derived from this study: PubMed 33655799Febvey-Combes O, Jobard E, Rossary A, Pialoux V, Foucaut AM, Morelle M, Delrieu L, Martin A, Caldefie-Chezet F, Touillaud M, Berthouze SE, Boumaza H, Elena-Herrmann B, Bachmann P, Tredan O, Vasson MP, Fervers B. Effects of an Exercise and Nutritional Intervention on Circulating Biomarkers and Metabolomic Profiling During Adjuvant Treatment for Localized Breast Cancer: Results From the PASAPAS Feasibility Randomized Controlled Trial. Integr Cancer Ther. 2021 Jan-Dec;20:1534735420977666. doi: 10.1177/1534735420977666.
- Derived from this study: PubMed 31729566Perrier L, Foucaut AM, Morelle M, Touillaud M, Kempf-Lepine AS, Heinz D, Gomez F, Meyrand R, Baudinet C, Berthouze S, Reynes E, Carretier J, Guillemaut S, Perol D, Tredan O, Philip T, Bachmann P, Fervers B. Cost-effectiveness of an exercise and nutritional intervention versus usual nutritional care during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2020 Jun;28(6):2829-2842. doi: 10.1007/s00520-019-05078-4. Epub 2019 Nov 15.
- Derived from this study: PubMed 30680617Foucaut AM, Morelle M, Kempf-Lepine AS, Baudinet C, Meyrand R, Guillemaut S, Metzger S, Bourne-Branchu V, Grinand E, Chabaud S, Perol D, Carretier J, Berthouze SE, Reynes E, Perrier L, Rebattu P, Heudel PE, Bachelot T, Bachmann P, Fervers B, Tredan O, Touillaud M. Feasibility of an exercise and nutritional intervention for weight management during adjuvant treatment for localized breast cancer: the PASAPAS randomized controlled trial. Support Care Cancer. 2019 Sep;27(9):3449-3461. doi: 10.1007/s00520-019-4658-y. Epub 2019 Jan 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick BACHMANN, MD principal investigator
Centre Leon Berard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention arm in people with Breast Cancer and Adequate Physical Condition, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01331772, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2014.