Clinical trial NCT05976815: Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients
Official title: Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients - The KEYMOVE Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Neoadjuvant Chemotherapy
Physical Exercise
Pathologic Complete Response
Immune System
Lead sponsor: University Institute of Maia
Sponsor class: OTHER
Collaborators: name: Aveiro University
name: Centro Hospitalar de Vila Nova de Gaia/Espinho
name: Associacao de Investigacao de Cuidados de Suporte em Oncologia
name: University of Maia
First posted: 2023-08-04
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. being female gender;
2. age equals or greater than 18 years old;
3. having a newly diagnosed histologically confirmed breast carcinoma IA-IIIC;
4. planned to receive neoadjuvant chemotherapy with anthracyclines or taxanes, that might be associated to anti-HER2 drugs;
5. being followed by the oncology department of the CHVNG/E;
6. medical oncologists consents the practice of physical exercise;
7. the patient is capable of providing written informed consent;
8. the participant accepts to be allocated to the control or experimental group, according to the randomization.

Exclusion Criteria:

1. previous cancer diagnostic;
2. evidence of synchronous oncologic disease;
3. physical or psychiatric contraindication to the practice of physical exercise.

Primary outcomes:
measure: Pathologic Complete Response
timeFrame: Post-intervention / Post-treatment. After neoadjuvant chemotherapy, and after surgery. Up to 33 weeks post-baseline.
Secondary outcomes:
measure: Treatment Tolerance - clinically assessed.
timeFrame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
measure: Treatment Tolerance - patient reported.
timeFrame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
measure: Chemotherapy Relative Dose Intensity
timeFrame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
measure: Number of Chemotherapy Dose Reductions
timeFrame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
measure: Number of Chemotherapy Delays
timeFrame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
measure: Number of Chemotherapy Early Discontinuations
timeFrame: From baseline (week 0) until the end of chemotherapy, an average of 26 weeks.
measure: Percentage of Tumor Infiltrating Lymphocytes
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks from study enrolment).
measure: Percentage of Tumor Ki67
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Percentage of Cytotoxic T Cells on Peripheral Blood
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Percentage of Natural Killer T Cells on Peripheral Blood
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Percentage of T Helper Cells on Peripheral Blood
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Plasma IFN-gamma levels
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Plasma TNF-alpha levels
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Plasma Irisin Levels
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Plasma SPARC levels
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Plasma Decorin Levels
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Plasma Oncostatin M Levels
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Distance traveled in the 10 meter-incremental shuttle walk test
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Maximal METS reached during a cardiopulmonary exercise test
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Number of repetitions performed in the 30 second sit-to-stand test
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Maximal Isometric Handgrip Strength
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Maximal Isometric Quadriceps Strength
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Weekly time time spent in light, moderate and vigorous physical activities and sedentary behaviours.
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Health-Related Quality of Life
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Total Body Weight
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Total Body Skeletal Muscle Mass
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Total Body Fat
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
measure: Body Mass Index
timeFrame: At baseline (week 0) and post-intervention (after an average of 30 weeks post study enrolment).
Other outcomes:
Locations:
city: Gaia
country: Portugal
facility: Centro Hospitalar Vila Nova Gaia e Espinho
state: Porto
Study officials:
affiliation: University of Maia
name: Nuno Rato, MSc
role: PRINCIPAL_INVESTIGATOR
References: