NCT06497322Not yet recruiting
Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment
Effectiveness of High-intensity Interval Training During Neoadjuvant Immunochemotherapy on Complete Remission in Patients With Triple-negative Breast Cancer
Source: ClinicalTrials.gov · Last updated 11 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In this randomized, controlled, prospective, two-arm intervention study, the investigators plan to investigate the effects of high-intensity interval training in women diagnosed with triple-negative breast cancer. Breast cancer is one of the most common cancers and one of the leading causes of cancer-related deaths worldwide. Among the different subtypes, triple-negative breast cancer accounts for about 15-20% of all breast cancer cases and is characterized by a more aggressive clinical course. Recent results indicate that the percentage of patients with a pathologic complete response was 13% higher in the chemotherapy-immunotherapy group (by 64.8%) than in the placebo-chemotherapy group (51.2). High-intensity interval training has a positive effect on the immune system, suggesting that it may improve the efficacy of chemo-immunotherapy, leading to a higher rate of pathologic complete response (pCR) in patients with newly diagnosed triple-negative breast cancer. In addition to the immunomodulatory effects, this exercise model could boost microvascular perfusion, thereby improving tumor perfusion, enhancing chemo-immunotherapy and leading to better outcomes.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- 1 Sept 2024
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- University Hospital of Cologne
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT06497322
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Sept 2024 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any history of previous systemic treatment for TNBC;
Lab values
- Any diseases that do not allow sports activity, such as:
- Clinically-manifest heart failure (NYHA III-IV);
- Respiratory partial or global insufficiency;
- Permanent thrombocytopenia \<10,000/µl, e.g., refractory autoimmune thrombocytopenia;
- Congenital or acquired thrombocytopathies or coagulation disorders.
- Symptomatic CHD (clearance certificate required, stress ECG and cardiac ultrasound recommended if necessary);
Age
- History of invasive malignancy ≤2 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
Other
- Participation in another exercise study;
Who the study is looking for
- Primary diagnosis of histologically verified triple-negative breast cancer (TNBC) measurable by ultrasound imaging
- Stage of disease: T1c and nodal status N1-2 or Stage T2-4 and nodal status N0-2
- Deemed eligible for intended treatment with Paclitaxel 80mg/m2 q1w x12, Carboplatin 1,5 AUC q1w x12, Pembrolizumab 200mg q3w x4 followed by Epirubicin 90mg/ m2 q3w x 4, Cyclophosphamid 600mg m2 q3w x 4, Pembrolizumab 200mg q3w x 4; by the treating physician
- Treatment in curative intent with life expectancy ≥ 3 months
- Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 12 months after the last dose of study treatment for participants who have received cyclophosphamide, and 6 months after the last dose of study treatment for participants who did not.
- Sufficient German language skills;
Age in the registry: 18 years to 85 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Cologne and St. Elizabeth Hospital Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.