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

NCT07311083 | Not Yet Recruiting

• 1 other identifier: 2024001-PV3
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Microbiome

Outcome Measures

Primary Outcomes (1)

• The primary target parameter is the feasibility of the planned study and the intervention.

  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.

  from the enrolment to the end of treatment at 6.5 months

Secondary Outcomes (10)

• 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

• α-diversity and β-diversity of the microbiome (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

Study Arms (2)

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.

Other: switching to a high-fibre diet

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)

Other: official dietary recommendations

Interventions

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)

control group receives official dietary recommendations

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.

Switching to a high-fibre diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemot

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kliniken Essen-Mitte: lead
• Karl and Veronica Carstens Foundation: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01