Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy

NCT ID: NCT07311083

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-07-01

Brief Summary

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.

Detailed Description

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.

Conditions

Microbiome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

switching to a high-fibre diet

Intervention Type: 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.

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)

Group Type: ACTIVE_COMPARATOR

official dietary recommendations

Intervention Type: OTHER

providing official dietary recommendations and an educational training video based on these recommendations of the guidelines of the German Nutrition Society (DGE)

Interventions

switching to a high-fibre diet

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.

Intervention Type: OTHER

official dietary recommendations

providing official dietary recommendations and an educational training video based on these recommendations of the guidelines of the German Nutrition Society (DGE)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karl and Veronica Carstens Foundation

OTHER

Sponsor Role: collaborator

Kliniken Essen-Mitte

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2024001-PV3

Identifier Type: -

Identifier Source: org_study_id