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Official title Feasibility of a Lifestyle Intervention for Women With Triple-negative Breast Cancer Under Neoadjuvant Immunotherapy
ClinicalTrials.gov ID: NCT07311083
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join 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...
- Willingness to participate in the study and signed consent form
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Essen, North Rhine-Westphalia, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Essen, North Rhine-Westphalia, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.