Bahrain Oncology Center
Al Muharraq, Bahrain
NCT Number: NCT07764341
The goal of this clinical trial is to learn whether supervised exercise is practical and safe for women receiving chemotherapy before surgery for breast cancer.
The main questions it aims to answer are:
* Can participants attend and complete the supervised exercise program during chemotherapy? * Is the exercise program safe? * Does exercise help maintain muscle mass, strength, quality of life, and chemotherapy delivery?
Participants will be assigned to either:
* supervised aerobic and strength exercise during chemotherapy, or * usual care without a study exercise program. Researchers will compare the two groups before and after chemotherapy.
Trial opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
Al Muharraq, Bahrain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Supervised combined aerobic and resistance exercise during neoadjuvant chemotherapy, delivered as two supervised sessions per week throughout the course of NACT.
Time frame: From initiation of the supervised exercise program through completion of neoadjuvant chemotherapy. The exercise program will continue throughout the full course of neoadjuvant chemotherapy, approximately 4-6 months depending on the treatment regimen.
Exercise adherence will be assessed in the exercise arm using physiotherapist-maintained session logs. Adherence is defined as attendance at ≥65% of prescribed supervised sessions during NACT, calculated as (sessions attended / sessions prescribed) × 100%. Prescribed sessions are the supervised sessions scheduled for the participant from randomization until completion of NACT or withdrawal from the study, whichever occurs first. The intervention will be considered feasible if at least 50% of participants randomized to the exercise arm meet the adherence threshold.
Time frame: SMI and SFI will be assessed at two time points: at baseline (pre-NACT) and at completion of NACT, which is expected to occur approximately 4-6 months after initiation of NACT and prior to surgery (post-NACT).
Skeletal muscle index (SMI) and subcutaneous fat index (SFI) will be measured on routine baseline and post-NACT computerized tomography (CT) images. SMI is defined as the cross-sectional area of skeletal muscle at the third lumbar vertebra (L3) on CT (in square centimeters) normalized for height (meters squared), yielding units of cm²/m².
SFI is defined as the cross-sectional area of subcutaneous fat at the third lumbar vertebra (L3) on CT (in square centimeters) normalized for height (meters squared), yielding units of cm²/m².
Time frame: Within one month after surgery.
pCR is defined as the absence of residual invasive cancer in the resected breast specimen and lymph nodes following NACT (allowing for residual in situ carcinoma), commonly denoted ypT0/Tis, ypN0. pCR will be determined based on the post-surgical pathology report.
Time frame: From initiation through completion of NACT, approximately 4-6 months.
Relative Dose Intensity (RDI): RDI is defined as the delivered dose intensity (mg/m²/week for each cytotoxic drug) expressed as a percentage of the planned dose intensity.
Dose reductions: Any reduction in chemotherapy dose below the initially planned dose (for reasons other than weight change) will be recorded.
Cycle delays: Any delay of a chemotherapy cycle by ≥7 days from the intended date (for toxicity or other patient factors) will be recorded.
Early discontinuation: If a patient permanently discontinues NACT before completing the planned number of cycles (due to toxicity, patient choice, etc.), that will be noted.
Time frame: At baseline (pre-NACT) and at completion of NACT, which is expected to occur approximately 4-6 months after initiation of NACT and prior to surgery (post-NACT).
Quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30, version 3 (EORTC QLQ-C30). Scores for each scale range from 0 to 100. Higher scores on the global health status and functioning scales indicate better health or functioning, while higher scores on the symptom scales indicate greater symptom severity.
Time frame: At baseline (pre-NACT) and at completion of NACT, which is expected to occur approximately 4-6 months after initiation of NACT and prior to surgery (post-NACT).
Breast cancer-specific quality of life will be measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module 23 (EORTC QLQ-BR23). Scores for each scale range from 0 to 100. Higher scores on the functioning scales indicate better functioning, while higher scores on the symptom scales indicate greater symptom severity.
Time frame: Grip strength will be measured at baseline (pre-NACT) and at completion of NACT, which is expected to occur approximately 4-6 months after initiation of NACT and prior to surgery (post-NACT).
Grip (in kg) strength will be assessed using handgrip dynamometry.
Time frame: From initiation of NACT through completion of NACT, approximately 4-6 months.
Safety will be evaluated by tracking adverse events (AEs) and serious adverse events (SAEs) throughout the study, particularly any events related to the exercise intervention. All participants will be assessed at each clinical visit for adverse events, and exercise session logs will also capture any symptoms or events during or after exercise.
Time frame: After completion of NACT and prior to surgery, approximately 4-6 months after initiation of NACT.
Tumor response on imaging will be assessed by RECIST 1.1 criteria on post-NACT scans.
Contact information is provided by the study sponsor or research team.
King Hamad University Hospital, Bahrain
Other
Supervised Exercise During Neoadjuvant Chemotherapy for Breast Cancer: Protocol for a Randomized Feasibility Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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