BREAst Cancer Personalised NuTrition (BREACPNT): dietary intervention in breast cancer survivors treated with endocrine therapy – a protocol for a randomised clinical trial
Introduction Breast cancer survivors treated with adjuvant endocrine therapy commonly experience weight gain, which has been associated with low adherence to therapy and worse breast cancer prognosis. We aim to assess whether a personalised postprandial glucose targeting diet will be beneficial for...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-11-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/11/e062498.full |
| _version_ | 1828183766573514752 |
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| author | Anastasia Godneva Dmitry Kolobkov Eran Segal Michal Sela Rein Maya Dadiani Michal Bakalenik-Gavry Dana Morzaev-Sulzbach Yaeli Vachnish maya Lotan-Pompan Adina Weinberger Einav Nili Gal-Yam |
| author_facet | Anastasia Godneva Dmitry Kolobkov Eran Segal Michal Sela Rein Maya Dadiani Michal Bakalenik-Gavry Dana Morzaev-Sulzbach Yaeli Vachnish maya Lotan-Pompan Adina Weinberger Einav Nili Gal-Yam |
| author_sort | Anastasia Godneva |
| collection | DOAJ |
| description | Introduction Breast cancer survivors treated with adjuvant endocrine therapy commonly experience weight gain, which has been associated with low adherence to therapy and worse breast cancer prognosis. We aim to assess whether a personalised postprandial glucose targeting diet will be beneficial for weight management as compared with the recommended Mediterranean diet in this patient populationMethods and analysis The BREAst Cancer Personalised NuTrition study is a phase-2 randomised trial in hormone receptor positive patients with breast cancer, treated with adjuvant endocrine therapy. The study objective is to assess whether dietary intervention intended to improve postprandial glycaemic response to meals results in better weight and glycaemic control in this population as compared with the standard recommended Mediterranean diet. Consenting participants will be assigned in a single blinded fashion to either of two dietary arms (Mediterranean diet or an algorithm-based personalised diet). They will be asked to provide a stool sample for microbiome analysis and will undergo continuous glucose monitoring for 2 weeks, at the initiation and termination of the intervention period. Microbiome composition data will be used to tailor personal dietary recommendations. After randomisation and provision of dietary recommendations, participants will be asked to continuously log their diet and lifestyle activities on a designated smartphone application during the 6-month intervention period, during which they will be monthly monitored by a certified dietitian. Participants’ clinical records will be followed twice yearly for 5 years for treatment adherence, disease-free survival and recurrence.Ethics and dissemination The study has been approved by the ethics committee in the Sheba medical centre (file 5725-18-SMC, Ramat Gan, Israel) and the Weizmann Institutional Review Board (file 693-2, Rehovot, Israel). The findings of this study will be published in a peer reviewed publication.Trial registration number NCT04079270. |
| first_indexed | 2024-04-12T06:36:43Z |
| format | Article |
| id | doaj.art-26ae86e912c24ad2a85ca055155c0986 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-12T06:36:43Z |
| publishDate | 2022-11-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-26ae86e912c24ad2a85ca055155c09862022-12-22T03:43:50ZengBMJ Publishing GroupBMJ Open2044-60552022-11-01121110.1136/bmjopen-2022-062498BREAst Cancer Personalised NuTrition (BREACPNT): dietary intervention in breast cancer survivors treated with endocrine therapy – a protocol for a randomised clinical trialAnastasia Godneva0Dmitry Kolobkov1Eran Segal2Michal Sela Rein3Maya Dadiani4Michal Bakalenik-Gavry5Dana Morzaev-Sulzbach6Yaeli Vachnish7maya Lotan-Pompan8Adina Weinberger9Einav Nili Gal-Yam10Department of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, IsraelDepartment of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, IsraelDepartment of Computer Science & Applied Mathematics, Weizmann Institute of Science, Rehovot, IsraelDepartment of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, IsraelCancer Research Center, Sheba Medical Center, Ramat Gan, IsraelCancer Research Center, Sheba Medical Center, Ramat Gan, IsraelCancer Research Center, Sheba Medical Center, Ramat Gan, IsraelCancer Research Center, Sheba Medical Center, Ramat Gan, IsraelDepartment of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, IsraelDepartment of Computer Science and Applied Mathematics, Weizmann Institute of Science, Rehovot, IsraelOncology Institute, Sheba Medical Center, Ramat Gan, IsraelIntroduction Breast cancer survivors treated with adjuvant endocrine therapy commonly experience weight gain, which has been associated with low adherence to therapy and worse breast cancer prognosis. We aim to assess whether a personalised postprandial glucose targeting diet will be beneficial for weight management as compared with the recommended Mediterranean diet in this patient populationMethods and analysis The BREAst Cancer Personalised NuTrition study is a phase-2 randomised trial in hormone receptor positive patients with breast cancer, treated with adjuvant endocrine therapy. The study objective is to assess whether dietary intervention intended to improve postprandial glycaemic response to meals results in better weight and glycaemic control in this population as compared with the standard recommended Mediterranean diet. Consenting participants will be assigned in a single blinded fashion to either of two dietary arms (Mediterranean diet or an algorithm-based personalised diet). They will be asked to provide a stool sample for microbiome analysis and will undergo continuous glucose monitoring for 2 weeks, at the initiation and termination of the intervention period. Microbiome composition data will be used to tailor personal dietary recommendations. After randomisation and provision of dietary recommendations, participants will be asked to continuously log their diet and lifestyle activities on a designated smartphone application during the 6-month intervention period, during which they will be monthly monitored by a certified dietitian. Participants’ clinical records will be followed twice yearly for 5 years for treatment adherence, disease-free survival and recurrence.Ethics and dissemination The study has been approved by the ethics committee in the Sheba medical centre (file 5725-18-SMC, Ramat Gan, Israel) and the Weizmann Institutional Review Board (file 693-2, Rehovot, Israel). The findings of this study will be published in a peer reviewed publication.Trial registration number NCT04079270.https://bmjopen.bmj.com/content/12/11/e062498.full |
| spellingShingle | Anastasia Godneva Dmitry Kolobkov Eran Segal Michal Sela Rein Maya Dadiani Michal Bakalenik-Gavry Dana Morzaev-Sulzbach Yaeli Vachnish maya Lotan-Pompan Adina Weinberger Einav Nili Gal-Yam BREAst Cancer Personalised NuTrition (BREACPNT): dietary intervention in breast cancer survivors treated with endocrine therapy – a protocol for a randomised clinical trial BMJ Open |
| title | BREAst Cancer Personalised NuTrition (BREACPNT): dietary intervention in breast cancer survivors treated with endocrine therapy – a protocol for a randomised clinical trial |
| title_full | BREAst Cancer Personalised NuTrition (BREACPNT): dietary intervention in breast cancer survivors treated with endocrine therapy – a protocol for a randomised clinical trial |
| title_fullStr | BREAst Cancer Personalised NuTrition (BREACPNT): dietary intervention in breast cancer survivors treated with endocrine therapy – a protocol for a randomised clinical trial |
| title_full_unstemmed | BREAst Cancer Personalised NuTrition (BREACPNT): dietary intervention in breast cancer survivors treated with endocrine therapy – a protocol for a randomised clinical trial |
| title_short | BREAst Cancer Personalised NuTrition (BREACPNT): dietary intervention in breast cancer survivors treated with endocrine therapy – a protocol for a randomised clinical trial |
| title_sort | breast cancer personalised nutrition breacpnt dietary intervention in breast cancer survivors treated with endocrine therapy a protocol for a randomised clinical trial |
| url | https://bmjopen.bmj.com/content/12/11/e062498.full |
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