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| Name | Class |
|---|---|
| Aveiro University | OTHER |
| Centro Hospitalar de Vila Nova de Gaia/Espinho | OTHER |
| Associacao de Investigacao de Cuidados de Suporte em Oncologia | OTHER |
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One of the recommended treatments for breast cancer is neoadjuvant chemotherapy (NCT), however, only 20% of the patients subject to this therapy present pathologic complete response (pCR). If exercise-induced tumour size reductions observed in preclinical studies translates to humans, physical training could emerge as a way of increasing rates of pCR to NCT, which would be a valuable clinical achievement. The present randomized controlled trial primary aim is to assess the impact of a physical exercise intervention the NCT efficacy. Following a parallel-arm design, 86 women with primary BC will be allocated 1:1 to a NCT + exercise (experimental) or NCT alone (control) group. The primary outcome is the rate of pCR in each group. Secondary outcomes include treatment tolerability and compliance, tumour infiltrating lymphocytes, ki67, immune, inflammatory, matricellular and myogenic markers, physical fitness, accelerometry, quality of life and body composition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The control group will receive neoadjuvant chemotherapy alone (standard of care). | |
| Experimental Group | Experimental | The experimental group will receive neoadjuvant chemotherapy (standard of care) in conjunction with an exercise intervention. The exercise intervention will be implemented concurrently for the full duration of the neoadjuvant chemotherapy treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Aerobic and Resistance Exercise | Behavioral | Apart from the neoadjuvant chemotherapy treatment (standard of care), participants allocated to the experimental group will additionally participate in a supervised physical exercise program that comprises 3 weekly sessions during the months that the patient is undergoing chemotherapy treatment. Each 75-minute session will comprise a 10-minute warm up, 30 minutes of strength training involving exercise for the major muscle groups, 30 minutes of aerobic training at 40-89% of heart rate reserve and a 5-minute cool down. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic Complete Response | Pathological response as the primary outcome will be assessed by a blinded pathologist from the tumour surgical specimens after the breast surgery (post-intervention) and will be defined as complete, partial or no response. Besides pathological complete response (defined as ypT0/ypN0), groups will be compared as those with response (complete or partial) versus those with no response. The residual cancer burden which quantifies residual disease after NAC (post-intervention) will also be assessed. | Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Tolerance - clinically assessed. | Number of participants with clinically assessed treatment-related adverse events. Will be assessed according to the Common Terminology Criteria for Adverse Events v5.0. The scale uses a minimal value of 1 and a maximal value of 5 to grade each adverse event, with higher scores representing worse outcomes. | From baseline (week 0) until the end of chemotherapy, an average of 26 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nuno D Rato, MSc | Contact | +351 919985852 | nuno.rato@umaia.pt | |
| Alberto Alves, PhD | Contact | ajalves@umaia.pt |
| Name | Affiliation | Role |
|---|---|---|
| Nuno Rato, MSc | University of Maia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Hospitalar Vila Nova Gaia e Espinho | Recruiting | Vila Nova de Gaia | Porto District | 4434-502 | Portugal |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| University of Maia |
| OTHER |
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|
| Treatment Tolerance - patient reported. | Number of participants with patient-reported adverse events. Will be assessed using the Patient reported outcomes version of the Common Terminology Criteria for Adverse Events v1.0 questionnaire. The scale uses a minimal rating 0 and a maximal rating of 4 to grade each adverse event, with higher scores representing worse outcomes. | From baseline (week 0) until the end of chemotherapy, an average of 26 weeks. |
| Chemotherapy Relative Dose Intensity | Chemotherapy relative dose intensity will be calculated by the following formula: (Delivered dose intensity / Standard dose intensity) x 100%, where Delivered dose intensity = (Delivered total dose, in mg/m2)/(actual time to complete chemotherapy with imputation for missed cycles, in days) and Standard Dose Intensity = (Standard total dose, in mg/m2)/(standard time to complete chemotherapy, in days). | From baseline (week 0) until the end of chemotherapy, an average of 26 weeks. |
| Number of Chemotherapy Dose Reductions | Number of patients that had to reduce the dose of chemotherapy from the dose of chemotherapy initially prescribed (standard dose intensity). | From baseline (week 0) until the end of chemotherapy, an average of 26 weeks. |
| Number of Chemotherapy Delays | Number of patients that had to delay a cycle of chemotherapy, in comparison to what had initially been prescribed (standard dose intensity). | From baseline (week 0) until the end of chemotherapy, an average of 26 weeks. |
| Number of Chemotherapy Early Discontinuations | Number of patients that had to interrupt chemotherapy before the standard dose had been administrated. | From baseline (week 0) until the end of chemotherapy, an average of 26 weeks. |
| Percentage of Tumor Infiltrating Lymphocytes | Assessed at Histology Slides. Intratumoral and stromal infiltrating lymphocyte (TIL) population will be assessed in tumour biopsies (at baseline) and surgical resection specimens collected from the post-neoadjuvant chemotherapy surgery (post-intervention). This will be used to compute intratumoral and stromal TIL's score, recorded as the percentage of TIL's on the analysed area. Only stromal TIL ́s will be quantified in patients with complete pathological response. | At baseline (week 0) and post-intervention (after an average of 30 weeks from study enrolment). |
| Percentage of Tumor Ki67 | Assessed at Histology Slides. Ki67 will be assessed in tumour biopsies (at baseline) and surgical resection specimens collected from the post-neoadjuvant chemotherapy surgery (post-intervention). | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Percentage of Cytotoxic T Cells on Peripheral Blood | Flow cytometry will be the method used to assess the number of CD3+CD8+ (cytotoxic T cells) on peripheral blood lymphocytes. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Percentage of Natural Killer T Cells on Peripheral Blood | Flow cytometry will be the method used to assess the number of CD3+CD56+ (natural killer T cells) on peripheral blood lymphocytes. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Percentage of T Helper Cells on Peripheral Blood | Flow cytometry will be the method used to assess the number of CD3+CD4+ (T helper cells) on peripheral blood lymphocytes. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Plasma IFN-gamma levels | The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine IFN-gamma on plasma. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Plasma TNF-alpha levels | The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine TNF-alpha on plasma. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Plasma Irisin Levels | The enzyme-linked immunosorbent assay method will be used to identify the concentration of the hormone Irisin on plasma. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Plasma SPARC levels | The enzyme-linked immunosorbent assay method will be used to identify the concentration of the protein SPARC on plasma. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Plasma Decorin Levels | The enzyme-linked immunosorbent assay method will be used to identify the concentration of the protein Decorin on plasma. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Plasma Oncostatin M Levels | The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine Oncostatin-M on plasma. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Distance traveled in the 10 meter-incremental shuttle walk test | As an indicator of cardiorespiratory fitness, the number of meters that the participant is able to walk/run in the 10 meter-incremental shuttle walk test will be assessed. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Maximal METS reached during a cardiopulmonary exercise test | The participant will be subjected to a maximal incremental conventional cardiopulmonary exercise test on a treadmill. The maximal intensity the participant is able to attain in this assessment will be recorded in METS. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Number of repetitions performed in the 30 second sit-to-stand test | The 30 second sit-to-stand test will be used to assess lower limb dynamic muscular strength. The maximal number of repetitions the participant is able to perform in the 30 second sit-to-stand test will be recorded. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Maximal Isometric Handgrip Strength | The maximal force (in kilograms) the participant is able to produce in an isometric handgrip test will be recorded, using a hand dynamometer. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Maximal Isometric Quadriceps Strength | The maximal force (in kilograms) the participant is able to produce in an isometric strength test for the quadriceps muscle will be recorded using a load cell. Additionally, the time to maximal strength (in seconds) will also be recorded. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Weekly time time spent in light, moderate and vigorous physical activities and sedentary behaviours. | Assessed by accelerometry over a period of seven days, the time (in minutes) that the participants spend in light, moderate and vigorous physical activity will be recorded. Additionally, the time (in minutes) spent in sedentary behaviours will also be recorded. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Health-Related Quality of Life | The questionnaires European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (version 1.0) and the Breast 23 Questionnaire (version 1.0) will be implemented to assess cancer-related quality of life. The final scores will range from 0 to 100, with higher scores on the functional scales representing a high level of functioning and higher scores on the symptom scales implying a stronger symptom burden. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Total Body Weight | Using bioimpedance, the participants' total body weight, in kilograms, will be assessed with the lightest clothes possible. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Total Body Skeletal Muscle Mass | Using bioimpedance, the participants' total body skeletal muscle mass, in kilograms, will be assessed. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Total Body Fat | Using bioimpedance, the participants' total body fat, in kilograms, will be assessed. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| Body Mass Index | Using weight and height, these parameters will be combined to report BMI in kg/m^2. | At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment). |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001519 | Behavior |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |