Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Current interventions as of 26/04/2023:
At diagnosis 300 women with early breast cancer will be recruited from across several hospital sites and studied prior to, during and after chemotherapy treatm
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 26/04/2023: 1. Early invasive breast carcinoma 2. Stage I-III disease 3. Tumour grade, ER and HER 2 status available 4. Clinical or pathological tumour size and lymph node status available 5. Neo-adjuvant or adjuvant systemic chemotherapy recommended by local breast multidisciplinary meeting 6. No prior systemic anti-cancer treatment within the past 10 years (hormonal therapy started since current breast cancer diagnosis (e.g. neoadjuvant or bridging endocrine therapy allowed) 7. No evidence of distant metastatic disease 8. Patient agrees to receive neo/adjuvant chemotherapy 9. Planned to receive greater than 4 x 21-day cycles of anthracycline or taxane-based combination chemotherapy. 21-day combination regimens including weekly treatments are allowed e.g. 1. carboplatin D1/paclitaxel D1, D8, D15 2. EC-weekly paclitaxel. Patients planned to receive the anthracycline component of the chemotherapy regimen at 2-weekly intervals (accelerated regimens) are additionally eligible for inclusion 10. Aged =18 years and <80 years 11. Female 12. Able to complete written records in English Previous inclusion criteria as of 27/07/2021 to 24/08/2021: 1. Early invasive breast carcinoma 2. Stage I-III disease 3. Tumour grade, ER and HER 2 status available 4. Clinical or pathological tumour size and lymph node status available 5. Neo-adjuvant or adjuvant systemic chemotherapy recommended by local breast multi-disciplinary meeting 6. No prior systemic anti-cancer treatment within the past 10 years 7. No evidence of distant metastatic disease 8. Patient agrees to receive neo/adjuvant chemotherapy 9. Planned to receive greater than 4 x 21-day cycles of anthracycline or taxane-based combination chemotherapy. 21-day combination regimens including weekly treatments are allowed e.g. 1. carboplatin D1/paclitaxel D1, D8, D15 2. EC-weekly paclitaxel 10. Aged =18 years and <80 years 11. Female 12. Able to complete written records in English Previous inclusion criteria as of 27/07/2021: 1. Early invasive breast carcinoma 2. Stage I-III disease 3. Tumour grade, ER and HER 2 status available 4. Clinical or pathological tumour size and lymph node status available 5. Neo-adjuvant or adjuvant systemic chemotherapy recommended by local breast multi-disciplinary meeting 6. No prior systemic anti-cancer treatment 7. No evidence of distant metastatic disease 8. Patient agrees to receive neo/adjuvant chemotherapy 9. Planned to receive greater than 4 x 21-day cycles of anthracycline or taxane-based combination chemotherapy. 21-day combination regimens including weekly treatments are allowed e.g. 1. carboplatin D1/paclitaxel D1, D8, D15 2. EC-weekly paclitaxel 10. Aged =18 years and <80 years 11. Female 12. Able to complete written records in English Previous inclusion criteria: 1. Early invasive breast carcinoma 2. Stage I-III disease 3. Tumour grade, ER and HER 2 status available 4. Clinical or pathological tumour size and lymph node status available 5. Neo-adjuvant or adjuvant systemic chemotherapy recommended by local breast multi-disciplinary meeting 6. No prior systemic anti-cancer treatment 7. No evidence of distant metastatic disease 8. Patient agrees to receive neo/adjuvant chemotherapy 9. Planned to receive 4-6 21 day cycles of anthracycline or taxane-based combination chemotherapy 10. Aged =18 years and <80 years 11. Female 12. Able to complete written records in English
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 11/02/2022: 1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) within the past 10 years 2. Any other medical conditions preventing physical participation in the study procedures 3. Patients receiving only single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab 4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies 5. Pregnancy 6. Pacemakers Previous exclusion criteria as of 24/08/2021: : 1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) within the past 10 years 2. Any other medical conditions preventing physical participation in the study procedures 3. Patients receiving only single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab 4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies 5. Pregnancy Previous exclusion criteria as of 27/07/2021: 1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) 2. Any other medical conditions preventing physical participation in the study procedures 3. Patients receiving only single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab 4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies 5. Pregnancy Previous exclusion criteria: 1. Previous invasive malignancy (with the exception of non-melanomatous skin cancer) 2. Any other medical conditions preventing physical participation in the study procedures 3. Patients receiving single agent or weekly neo/adjuvant chemotherapy regimens e.g. weekly paclitaxel with trastuzumab 4. Patients with existing conditions known to affect body water or cause oedema or muscle conditions that may affect muscle mass such as muscular dystrophies 5. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 09/11/2021: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (2-6 weeks and 3 months): 1. FMi determined by sBIA using the Seca mBCA 515 2. Chemotoxicity reporting according to the NCI Common Toxicity Criteria (version 5.0, Nov 17) Previous primary outcome measure: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (3 weeks and 3 months): 1. FMi determined by sBIA using the Seca mBCA 515 2. Chemotoxicity reporting according to the NCI Common Toxicity Criteria (version 5.0, Nov 17) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/04/2023: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (2-6 weeks and 3 months) unless otherwise stated: 1. Grip strength using JAMAR hydraulic hand dynamometer at every study visit 2. sBIA to measure bioelectrical properties and body composition using the Seca mBCA 515 at every study visit 3. Quality of life and lifestyle using validated questionnaires: At visit 1: AUDIT-C, EORTC QLQC30, EORTC QLQ-BR23, IPAQ-SF and CNAQ. At visit 4, and at follow-ups 3 weeks and 3 months: EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ 4. Chemotoxicity assessments according to the standardised NCTAE v5.0 criteria: At every study visit (APART FROM VISIT 1) 5. If and when clinically indicated body composition by sliceomatic analysis from routine care CT scans: This would usually be prior to commencement of chemotherapy but timings may be variable. Previous secondary outcome measures as of 23/09/2021 to 09/11/2021: At every study visit prior to each cycle of chemotherapy (4-8 visits) and at follow-ups (2-6 weeks and 3 months) unless otherwise stated: 1. Grip strength using JAMAR hydraulic hand dynamometer at every study visit 2. sBIA to measure bioelectrical properties and body composition using the Seca mBCA 515 at every study visit 3. Quality of life and lifestyle using validated questionnaires: At visit 1: AUDIT-C, EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ. At visit 4, and at follow-ups 3 weeks and 3 months: EORTC QLQ-C30, EORTC QLQ-BR23, IPAQ-SF and CNAQ 4. Chemotoxicity assessments according to the standardised NCTAE v5.0 criteria: At every study visit (APART FROM VISIT 1) 5. If and when clinically indicated body composition by sliceomatic analysis from routine care CT scans: This would usually be prior to commencement of chemotherapy but timings may be variable As part of the optional Southampton mechanistic sub-study only: 6. Body composition by DXA using a Lunar Hologic scanner at v | — |
Countries
England, United Kingdom
Contacts
Public ContactKesta Durkin
Outcome results
None listed