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| Name | Class |
|---|---|
| Karl and Veronica Carstens Foundation | OTHER |
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Triple-negative breast cancer (TNBC) is considered a tumor with a high risk of recurrence and metastasis and requires aggressive systemic therapy combining immunotherapy and chemotherapy. If the therapy leads to complete remission (pCR), this is prognostically beneficial for patients.
Studies demonstrating the influence of the microbiome on the development of cancer and on the efficacy and toxicity of immunotherapy and chemotherapy underscore the potential of targeted nutritional interventions. Current data from microbiome research indicate that a high-fiber, gut-healthy diet modulates the microbiota in such a way that the response to and toxicity of immunotherapy and chemotherapy could be improved.
The aim of this project is to translate these findings into clinical care. The study will investigate whether an online integrative oncology group training program with mind-body elements supports and is feasible for the implementation of a high-fiber diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemotherapy. The program will be compared with a control group that receives a flyer with nutritional recommendations. If the feasibility of this complementary medicine approach can be demonstrated, a confirmatory study is planned to investigate the expected effect on the pathological complete remission of TNBC.
This study examines a nutritional concept developed specifically for this study with regard to the implementation of a switch to a high-fibre diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemotherapy. This nutritional concept is embedded in an online, integrative oncology group training programme with mind-body medicine elements to support the change in diet and its tolerability. This intervention is compared with a control group that receives standard care, i.e. a flyer and an educational training video with nutritional recommendations based on the guidelines of the German Nutrition Society (DGE).
The following criteria have been established to determine the feasibility of these two target levels:
If the study proves feasible and demonstrates the viability of this integrative medical approach in women with TNBC undergoing neoadjuvant immunotherapy, a confirmatory intervention study with a larger sample size is planned. This study aims to contribute to expanding the current knowledge base and improving existing treatment options. The follow-up study aims to investigate the effects of the nutritional concept and the group training programme on the pCR of TNBC. It will analyse whether the nutritional concept and the group training programme enhance the response to immunotherapy and improve its tolerability in the study participants. The findings from this study will therefore be incorporated into the follow-up study, which will investigate the potential for an improved immune response to therapy and, at the same time, identify possible positive effects of the nutritional intervention on the side effect profile of immunotherapy. Furthermore, the design of the nutritional concept and/or the group training programme could be adapted for the follow-up study if the results are appropriate. The findings from both studies will then be transferred to clinical care, thereby optimising the current treatment options for TNBC patients and increasing their chances of recovery in the long term.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switching to a high-fibre diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemot | Active Comparator | Switching to a high-fibre diet is supported by multi-professional consultation hours, individual counselling and group sessions that combine mind-body medicine and nutritional therapy content. |
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| control group receives official dietary recommendations | Active Comparator | Control group receives standard care, i.e. a leaflet and an educational training video with dietary recommendations of the Deutsche Gesellschaft fuer Ernaehrung (DGE) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| switching to a high-fibre diet | Other | The aim of the intervention is to support patients in implementing a high-fibre diet (20-30 g of fibre per day) before and during systemic therapy. A multi-professional team consisting of a specialist doctor, a qualified nutritionist and an MBM therapist ensures comprehensive support during lifestyle modification. While the nutritional counselling provides recommendations for optimising diet, the MBM intervention addresses behavioural factors such as motivation, self-efficacy expectations and dealing with barriers to action. In addition, the specialist provides advice on symptom management. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary target parameter is the feasibility of the planned study and the intervention. | The feasibility criteria are defined in the following categories: Recruitment:
Data collection: Data collection is considered feasible if complete data on the planned primary endpoint parameter of the planned confirmatory study, pCR, is available for at least 80% of the patients who complete the study. | from the enrolment to the end of treatment at 6.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Course of therapy (pCR) | Course of therapy in the sense of a complete response to systmatic therapy (= complete pathological remission) | 6 months after baseline |
| Toxicity (CTCAE 6.0) including adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evang. Kliniken Essen-Mitte gGmbH | Recruiting | Essen | North Rhine-Westphalia | 45276 | Germany |
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| official dietary recommendations | Other | providing official dietary recommendations and an educational training video based on these recommendations of the guidelines of the German Nutrition Society (DGE) |
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adverse events
| 6 months after baseline |
| Fatty acid profile (stool sample analysis) | Fatty acid profile | baseline and 6 months after baseline |
| α-diversity and β-diversity of the microbiome (stool sample analysis) | diversity of the microbiome | baseline and 6 months after baseline |
| Body weight | Body weight | baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline |
| Self-reported quality of life (FACT-B = Functional Assessment of Cancer Therapy - Breast) | quality of life, ranges from 0 to 4, with lower scores indicating higher stress levels which means a lower quality of life | baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline |
| Self-reported fatigue (FACIT fatigue = Functional Assessment of Chronic Illness Therapy Fatgigue) | Self-reported fatigue, scale from 0 to 4 with lower value indicating a greater fatigue. Two items are reversed. | baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline |
| Self-reported fiber intake (dietary records) | Self-reported fiber intake | baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline |
| Self-reported tolerance of increased fiber intake (IBS-SSS = irritable bowel syndrome severity scoring system) | Self-reported tolerance of increased fiber intake, symptoms are rated on a visual analog scale (VAS) from 0 to 100 points. 100 points indicate the most severe irritable bowel symptoms. | baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline |
| Adverse Events and Serious Adverse Events | Adverse Events and Serious Adverse Events | baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline |