- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05976815
Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients (KEYMOVE)
September 6, 2023 updated by: Alberto Alves, University Institute of Maia
Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients - The KEYMOVE Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nuno D Rato, MSc
- Phone Number: +351 919985852
- Email: nuno.rato@umaia.pt
Study Contact Backup
- Name: Alberto Alves, PhD
- Email: ajalves@umaia.pt
Study Locations
-
-
Porto
-
Gaia, Porto, Portugal, 4434-502
- Recruiting
- Centro Hospitalar Vila Nova Gaia e Espinho
-
Contact:
- Nuno Rato, MSc
- Phone Number: +351919985852
- Email: nuno.rato@umaia.pt
-
Principal Investigator:
- Nuno Rato, MSc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- being female gender;
- age equals or greater than 18 years old;
- having a newly diagnosed histologically confirmed breast carcinoma IA-IIIC;
- planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, that might be associated to anti-HER2 drugs;
- being followed by the oncology department of the CHVNG/E;
- medical oncologists consents the practice of physical exercise;
- the patient is capable of providing written informed consent;
- the participant accepts to be allocated to the control or experimental group, according to the randomization.
Exclusion Criteria:
- previous cancer diagnostic;
- evidence of synchronous oncologic disease;
- physical or psychiatric contraindication to the practice of physical exercise.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control Group
The control group will receive neoadjuvant chemotherapy alone (standard of care).
|
|
Experimental: Experimental Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathologic Complete Response
Time Frame: Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment Tolerance - clinically assessed.
Time Frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
|
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.
|
Treatment Tolerance - patient reported.
Time Frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
|
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
Time Frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
|
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
Time Frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
|
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
Time Frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
|
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
Time Frame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
|
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
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks from study enrolment).
|
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).
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Percentage of Tumor Ki67
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
|
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
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Flow cytometry will be the method used to assess the number of CD3+CD8+ (cytotoxic T cells) on peripheral blood lymphocytes.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Percentage of Natural Killer T Cells on Peripheral Blood
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Flow cytometry will be the method used to assess the number of CD3+CD56+ (natural killer T cells) on peripheral blood lymphocytes.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Percentage of T Helper Cells on Peripheral Blood
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Flow cytometry will be the method used to assess the number of CD3+CD4+ (T helper cells) on peripheral blood lymphocytes.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Plasma IFN-gamma levels
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
|
The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine IFN-gamma on plasma.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Plasma TNF-alpha levels
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine TNF-alpha on plasma.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Plasma Irisin Levels
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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The enzyme-linked immunosorbent assay method will be used to identify the concentration of the hormone Irisin on plasma.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Plasma SPARC levels
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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The enzyme-linked immunosorbent assay method will be used to identify the concentration of the protein SPARC on plasma.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Plasma Decorin Levels
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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The enzyme-linked immunosorbent assay method will be used to identify the concentration of the protein Decorin on plasma.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Plasma Oncostatin M Levels
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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The enzyme-linked immunosorbent assay method will be used to identify the concentration of the cytokine Oncostatin-M on plasma.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Distance traveled in the 10 meter-incremental shuttle walk test
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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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.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Maximal METS reached during a cardiopulmonary exercise test
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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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).
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Number of repetitions performed in the 30 second sit-to-stand test
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
|
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.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Maximal Isometric Handgrip Strength
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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The maximal force (in kilograms) the participant is able to produce in an isometric handgrip test will be recorded, using a hand dynamometer.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Maximal Isometric Quadriceps Strength
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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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.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Weekly time time spent in light, moderate and vigorous physical activities and sedentary behaviours.
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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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.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Health-Related Quality of Life
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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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.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Total Body Weight
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Using bioimpedance, the participants' total body weight, in kilograms, will be assessed with the lightest clothes possible.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Total Body Skeletal Muscle Mass
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Using bioimpedance, the participants' total body skeletal muscle mass, in kilograms, will be assessed.
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At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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Total Body Fat
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
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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).
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Body Mass Index
Time Frame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
|
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).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Nuno Rato, MSc, University of Maia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 31, 2023
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
June 6, 2023
First Submitted That Met QC Criteria
July 27, 2023
First Posted (Actual)
August 4, 2023
Study Record Updates
Last Update Posted (Actual)
September 7, 2023
Last Update Submitted That Met QC Criteria
September 6, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- keymove
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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