Feasibility of a Lifestyle Intervention to Switch to a High-fiber, Gut-healthy Diet in Women With Triple-negative Breast Cancer Undergoing Neoadjuvant Immunotherapy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary target parameter is the feasibility of the planned study and the intervention.
研究概览
简要总结
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.
详细描述
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:
- Recruitment
- Consent to participate and randomisation
- Dropout rate
- Implementation of the intervention (dietary change and acceptance/effect of mind-body elements)
- Completeness of data collected for at least 80% of patients who complete the study
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-75
- •Histologically confirmed diagnosis of non-metastatic triple-negative breast cancer (TNM stage I-III) with planned neoadjuvant chemotherapy and immunotherapy
- •Willingness to participate in the study and signed consent form
排除标准
- •Advanced stage of disease with metastases
- •Severe physical or psychopharmacologically treated psychiatric comorbidity that prevents a patient from participating in the study
- •Pregnancy
- •Participation in other clinical studies involving behavioral, psychological, or complementary medical interventions
- •A diet that is incompatible with a high-fiber diet, such as the ketogenic diet
- •Abuse of drugs and/or alcohol
- •Inability to complete the questionnaires independently
- •Colectomy
- •Gastrointestinal stenosis
- •Fructose intolerance
- •Histamine intolerance
- •Gluten intolerance
- •Ketogenic diet
- •Unwillingness to refrain from taking probiotics for the duration of the study
- •Eating disorders
- •No laptop and/or camera available to participate in the online group training program
研究组 & 干预措施
Switching to a high-fibre diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemot
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.
干预措施: switching to a high-fibre diet (Other)
control group receives official dietary recommendations
Control group receives standard care, i.e. a leaflet and an educational training video with dietary recommendations of the Deutsche Gesellschaft fuer Ernaehrung (DGE)
干预措施: official dietary recommendations (Other)
结局指标
主要结局
The primary target parameter is the feasibility of the planned study and the intervention.
时间窗: from the enrolment to the end of treatment at 6.5 months
The feasibility criteria are defined in the following categories: Recruitment: * Recruitment is considered feasible if the required sample size of n = 60 patients can be recruited within 17 months. * Randomisation: Randomisation is considered feasible if at least 25% of potentially eligible patients agree to participate in the study * Dropout rate: A maximum dropout rate of 20% per group is considered proof of feasibility. * Intervention: The intervention is considered feasible if at least 80% of the patients who complete the study are able to implement the nutritional intervention according to protocol. Implementation according to protocol is defined as a fibre intake of at least 20 g/day and the consumption of fermented foods. 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.
次要结局
- Course of therapy (pCR)(6 months after baseline)
- Toxicity (CTCAE 6.0) including adverse events (AEs)(6 months after baseline)
- Fatty acid profile (stool sample analysis)(baseline and 6 months after baseline)
- Body weight(baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline)
- α-diversity and β-diversity of the microbiome (stool sample analysis)(baseline and 6 months after baseline)
- Self-reported fatigue (FACIT fatigue = Functional Assessment of Chronic Illness Therapy Fatgigue)(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)(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)(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)(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(baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline)