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Trial Title:
Improving Response to Chemotherapy by Adding Physical Exercise in the Neoadjuvant Setting of Breast Cancer Patients
NCT ID:
NCT05976815
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Neoadjuvant Chemotherapy
Physical Exercise
Pathologic Complete Response
Immune System
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Combined Aerobic and Resistance Exercise
Description:
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.
Arm group label:
Experimental Group
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centro Hospitalar Vila Nova Gaia e Espinho
Address:
City:
Gaia
Zip:
4434-502
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Nuno Rato, MSc
Phone:
+351919985852
Email:
nuno.rato@umaia.pt
Investigator:
Last name:
Nuno Rato, MSc
Email:
Principal Investigator
Start date:
July 31, 2023
Completion date:
August 1, 2026
Lead sponsor:
Agency:
University Institute of Maia
Agency class:
Other
Collaborator:
Agency:
Aveiro University
Agency class:
Other
Collaborator:
Agency:
Centro Hospitalar de Vila Nova de Gaia/Espinho
Agency class:
Other
Collaborator:
Agency:
Associacao de Investigacao de Cuidados de Suporte em Oncologia
Agency class:
Other
Collaborator:
Agency:
University of Maia
Agency class:
Other
Source:
University Institute of Maia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05976815
