Status:
ACTIVE_NOT_RECRUITING
Supervised Physical Activity in Young Women With Early Breast Cancer During Neoadjuvant Chemotherpy
Lead Sponsor:
The Greater Poland Cancer Centre
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The main goal of this study is to assess the impact of supervised intense physical activity (IPA) on outcomes of neoadjuvant chemotherapy in young women with breast cancer (YWBC). In this project stan...
Detailed Description
The main goal of this study is to assess the impact of supervised intense physical activity (IPA) on outcomes of neoadjuvant chemotherapy in young women with breast cancer (YWBC). In this project stan...
Eligibility Criteria
Inclusion
- women between 18 and 40 years of age,
- with a known breast cancer, triple - negative or HER2 positive when the tumor size is ≥ 2cm and / or when cancer metastases to axillary lymph nodes or with luminal cancer at tumor size\> 3 cm are present,
- qualified for preoperative chemotherapy,
- ECOG 0-1,
- correct left ventricular ejection fraction of at least 50%
- correct results of laboratory tests for bone marrow, liver and kidney function (leukocytes ≥ 3 x 109 / l, neutrocytes ≥ 1.5 x 109 / l, hemoglobin ≥ 9 mg / dl \[5.59 mmol / l\], platelets ≥ 100 x 109 / l, AST / ALT ≤ 3 x ULN, bilirubin ≤ 1.5 x ULN, creatinine ≤ 1.5 ULN).
Exclusion
- diagnosis with cancer other than breast cancer in the last 5 years, except in situ melanoma, in situ cervical cancer, basal cell and squamous cell carcinoma.
- other contraindications for planned systemic treatment: doxorubicin, cyclophosphamide, paclitaxel, trastuzumab, pertuzumab.
- Pregnant and breastfeeding patients.
- Patients infected with HIV, HCV, HBV, after organ transplantation or suffering from an autoimmune disease requiring immunosuppressive treatment. If there are diseases of the musculoskeletal system or other, according to the doctor, preventing the patient from participating in the study or threatening her life and health if the planned intervention is used, the patient should not be included in the study.
Key Trial Info
Start Date :
October 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06190600
Start Date
October 11 2018
End Date
December 31 2026
Last Update
April 30 2025
Active Locations (1)
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1
Ewa Tanska
Poznan, Polska, Poland, 61-866