MicrobiomeBallastImmunNCT07311083
Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
A study testing switching to a high-fibre diet and official dietary recommendations in people with Microbiome, run by Kliniken Essen-Mitte at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Microbiome
- What is being tested?
- switching to a high-fibre diet and official dietary recommendations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Evang. Kliniken Essen-Mitte gGmbH
Essen, North Rhine-Westphalia, 45276
Petra Voiss, PD Dr., 004920117439001, p.voiss@kem-med.com
About this study
Official title: 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
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.
Read the 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
- Being tested
- switching to a high-fibre diet, official dietary recommendations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
switching to a high-fibre dietOther
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.
official dietary recommendationsOther
providing official dietary recommendations and an educational training video based on these recommendations of the guidelines of the German Nutrition Society (DGE)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Other: official dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from the enrolment to the end of treatment at 6.5 months
Secondary outcomes (10)
Course of therapy (pCR)
Course of therapy in the sense of a complete response to systmatic therapy (= complete pathological remission)
Measured: 6 months after baseline
Toxicity (CTCAE 6.0) including adverse events (AEs)
adverse events
Measured: 6 months after baseline
Fatty acid profile (stool sample analysis)
Fatty acid profile
Measured: baseline and 6 months after baseline
α-diversity and β-diversity of the microbiome (stool sample analysis)
diversity of the microbiome
Measured: baseline and 6 months after baseline
Body weight
Body weight
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 Feb 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311083
- Sponsor's protocol ID
- 2024001-PV3
- Acronym
- BallastImmun
- Status last verified
- May 2026
- First submitted
- 16 Dec 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07311083
- Acronym / sponsor ID
- BallastImmun / 2024001-PV3
- Conditions
- Microbiome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Collaborators
- Karl and Veronica Carstens Foundation
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Switching to a high-fibre diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemot | Active comparator | Other: switching to a high-fibre dietSwitching 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. |
| control group receives official dietary recommendations | Active comparator | Other: official dietary recommendationsControl group receives standard care, i.e. a leaflet and an educational training video with dietary recommendations of the Deutsche Gesellschaft fuer Ernaehrung (DGE) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| switching to a high-fibre dietThe 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. | Other | Switching to a high-fibre diet in patients with TNBC undergoing neoadjuvant immunotherapy and chemot |
| official dietary recommendationsproviding official dietary recommendations and an educational training video based on these recommendations of the guidelines of the German Nutrition Society (DGE) | Other | control group receives official dietary recommendations |
Primary outcome
The primary target parameter is the feasibility of the planned study and the intervention.
Time frame: 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.
10 secondary outcomes
Course of therapy (pCR)
Time frame: 6 months after baseline
Toxicity (CTCAE 6.0) including adverse events (AEs)
Time frame: 6 months after baseline
Fatty acid profile (stool sample analysis)
Time frame: baseline and 6 months after baseline
α-diversity and β-diversity of the microbiome (stool sample analysis)
Time frame: baseline and 6 months after baseline
Body weight
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: baseline, 1 to 3 weeks after baseline (start of the chemotherapy), 3 months after baseline, 6 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing switching to a high-fibre diet and official dietary recommendations in people with Microbiome, run by Kliniken Essen-Mitte at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary target parameter is the feasibility of the planned study and the intervention. (time frame: from the enrolment to the end of treatment at 6.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.