Exercise Intervention in Women Diagnosed With Triple-negative Breast Cancer Receiving Oncologic Treatment

Launched by UNIVERSITY HOSPITAL OF COLOGNE · Jul 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how high-intensity interval training (a type of exercise that alternates between short bursts of intense activity and rest) can help women diagnosed with triple-negative breast cancer while they are receiving treatment. Triple-negative breast cancer is a more aggressive form of breast cancer that can be challenging to treat. The researchers believe that this exercise may boost the immune system and improve how well the treatments work, potentially leading to better outcomes for patients.

To be eligible for this trial, participants must be women aged 65 to 74 with a confirmed diagnosis of triple-negative breast cancer that can be seen on ultrasound. They should also be starting specific chemotherapy and immunotherapy treatments, and their doctors must expect that these treatments could help them live for at least three more months. Participants will engage in the exercise program alongside their standard treatments, which could help enhance their overall health during this challenging time. It's important to note that women who are pregnant or have certain health conditions may not be able to participate in this study.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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;
• Exclusion Criteria:
• • 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.
• • Any history of previous systemic treatment for TNBC;
• * 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);
• • Participation in another exercise study;