Physical ExerciseNEOLIFENCT04135586
Effects of a Physical Exercise Intervention During Neoadjuvant Chemotherapy in Women With Breast Cancer
A study testing Exercise training in people with Physical Exercise, run by Universidad Europea de Madrid at 2 sites in Spain.
Trial summary
To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO). Read more about this study
- Who is it for?
- Ages 25 to 75 years, women only
- Conditions the study is for
- Physical Exercise
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2020to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with breast carcinoma in the 'Hospital Universitario Quirónsalud de Pozuelo' (Madrid, Spain) and following neoadjuvant therapy in the aforementioned center.
- Must have triple negative breast cancer (i.e., negative for estrogen receptors, progesterone receptors, and excess HER2 protein) of size > or equal to 15 mm
Who cannot join
- Not meeting all of the above.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario Quirónsalud de Pozuelo (HUQP)
Madrid
Lucía G Cortijo, MD, +34651835021, lgcortijo@gmail.com
Lucía G Cortijo
- Recruiting
Lgcortijo@Gmail.Com
Madrid
Lucía G Cortijo, MD, +34651835021, lgcortijo@gmail.com
About this study
Official title: Effects of a Physical Exercise Intervention at the Molecular Systemic and Tumor Level Performed During Neoadjuvant Chemotherapy in Women With Breast Cancer
To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).
Read the detailed description
Justification and aims Breast cancer is the fourth most common type of cancer worldwide and the first among women in Spain. It is also the type of cancer with the highest mortality. Several studies have assessed the effects of exercise performed in the neo-adjuvant period, but there is heterogeneity among them.
Principal aim:
To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).
Secondary aims:
To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.
- Conditions
- Physical Exercise
- Being tested
- Exercise training, Control
- Keywords
- exercise, high interval training, resistance exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Exercise program for 24 weeks (with neo-adjuvant treatment), with two sessions per week including both moderate-to-intense aerobic and resistance training. The intensity of each type of exercise will range between 65% and 100% of the maximum score in the Rated Perceived Exertion (RPE) scale.
ControlOther
Yoga + educational program
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | The patients in this arm will follow an exercise program for 24 weeks (i.e., during neo-adjuvant treatment), with two sessions per week including both aerobic and resistance training. Exercise intensity will range between 65% and 100% of the maximum score in the scale of Rated Perceived Exertion (RPE). Receives: Other: Exercise training |
| Control | Other | The patients follow their usual habits as well as a Yoga program. They will also receive educational sessions on the benefits of regular physical activity (brisk walking). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion
Measured: Change from baseline to end of intervention (i.e., after 24 weeks)
muscle dynamic strength
Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair)
Measured: Change from baseline to end of intervention (i.e., after 24 weeks)
handgrip strength
handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg)
Measured: Change from baseline to end of intervention (i.e., after 24 weeks)
Secondary outcomes (3)
Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23])
The QLQ-C30 is a multidimensional cancer HRQoL questionnaire that contains 30 items assessing six functional and nine symptom scales. Results from this questionnaire are transformed into scores ranging from 0 to 100 according to European Organization for Research and Treatment of Cancer (EORTC) scoring, with higher scores in the functioning scales indicating a better functional status and global HRQoL, and higher scores on the symptoms' scales indicating more symptoms.
Measured: Change from baseline to end of intervention (i.e., after 24 weeks)
Body composition (fat mass)
fat mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry
Measured: Change from baseline to end of intervention (i.e., after 24 weeks)
Body composition (lean body mass)
lean body mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry
Measured: Change from baseline to end of intervention (i.e., after 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start1 Jan 2020
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Physical exercise intervention (24 weeks)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alejandro Lucia, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135586
- Sponsor's protocol ID
- UEM Quirón
- Acronym
- NEOLIFE
- Status last verified
- Jun 2024
- First submitted
- 8 Oct 2019
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Exercise Intervention at the Molecular Systemic and Tumor Level Performed During Neoadjuvant Chemotherapy in Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT04135586
- Acronym / sponsor ID
- NEOLIFE / UEM Quirón
- Conditions
- Physical Exercise
- Keywords
- exercise, high interval training, resistance exercise
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).
Detailed description
Justification and aims Breast cancer is the fourth most common type of cancer worldwide and the first among women in Spain. It is also the type of cancer with the highest mortality. Several studies have assessed the effects of exercise performed in the neo-adjuvant period, but there is heterogeneity among them.
Principal aim:
To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).
Secondary aims:
To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Physical exercise intervention (24 weeks)
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise trainingThe patients in this arm will follow an exercise program for 24 weeks (i.e., during neo-adjuvant treatment), with two sessions per week including both aerobic and resistance training. Exercise intensity will range between 65% and 100% of the maximum score in the scale of Rated Perceived Exertion (RPE). |
| Control | Other | Other: ControlThe patients follow their usual habits as well as a Yoga program. They will also receive educational sessions on the benefits of regular physical activity (brisk walking). |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with breast carcinoma in the 'Hospital Universitario Quirónsalud de Pozuelo' (Madrid, Spain) and following neoadjuvant therapy in the aforementioned center.
- Must have triple negative breast cancer (i.e., negative for estrogen receptors, progesterone receptors, and excess HER2 protein) of size > or equal to 15 mm
Key exclusion criteria (1 listed)
- Not meeting all of the above.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingExercise program for 24 weeks (with neo-adjuvant treatment), with two sessions per week including both moderate-to-intense aerobic and resistance training. The intensity of each type of exercise will range between 65% and 100% of the maximum score in the Rated Perceived Exertion (RPE) scale. | Other | Exercise |
| ControlYoga + educational program | Other | Control |
Primary outcome
Cardiorespiratory fitness
Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)
peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion
muscle dynamic strength
Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)
Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair)
handgrip strength
Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)
handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg)
3 secondary outcomes
Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23])
Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)
Body composition (fat mass)
Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)
Body composition (lean body mass)
Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Physical Exercise, run by Universidad Europea de Madrid at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: Change from baseline to end of intervention (i.e., after 24 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.