Breast CancerNCT05656716
Multimodal Project
A study testing Nutritional intervention and Physical exercise intervention in people with Breast Cancer, run by Universidad de Granada at 1 site in Spain.
Trial summary
The main aim of this study is to determine the effect of a multimodal intervention (Nutrition and Exercise) on quality of life, emotional well-being, and secondary symptomatology in patients diagnosed with breast cancer during neoadjuvant chemotherapy treatment, and to compare them with the control group. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Nutritional intervention and Physical exercise intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jan 2023to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with breast cancer who will undergo neoadjuvant treatment in the Oncology Unit of the Virgen de las Nieves University Hospital of Granada.
- Aged between 18 and 75 years.
- Give their consent to participate in the study and commit to complete the entire intervention and attend their follow-up appointments.
- Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols
Who cannot join
- Patients who are unwilling or unable to comply with the established guidelines by means of an intervention in diet and physical exercise and/or who present physical or psychological pathologies that contraindicate their inclusion in the study.
- Patients who do not register the data required for follow-up.
- Any condition that, in the investigator's opinion, impairs the ability to participate in the study or represents a personal risk for the participant.
- Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Granada
Granada
Lucas Jurado-Fasoli, PhD
About this study
Official title: Effect of a Multimodal Intervention on the Response to Neoadjuvant Therapy in Breast Cancer Patients.
The main aim of this study is to determine the effect of a multimodal intervention (Nutrition and Exercise) on quality of life, emotional well-being, and secondary symptomatology in patients diagnosed with breast cancer during neoadjuvant chemotherapy treatment, and to compare them with the control group.
Read the detailed description
Multiple studies have demonstrated the relationship between obesity, sedentary lifestyle and stress on the risk of developing various types of cancer, including breast cancer. The correlation between a high Body Mass Index (BMI) and a worse prognosis in patients already diagnosed with breast cancer has also been studied, as well as the tendency to gain weight during chemotherapy treatments. A low-fat dietary pattern has been associated with reduced mortality after a breast cancer diagnosis, through mechanisms that decrease the likelihood of developing metabolic syndrome and reduce estradiol levels. In recent years, the importance of healthy lifestyle habits in improving the quality of life of these patients has also been demonstrated.
Although BMI is an easy-to-obtain marker of obesity, it is a rather crude measure that does not fully reflect the dysfunctional activity of visceral fat (VAT), which appears to be a key pathophysiological mechanism determining the clinical and metabolic consequences of obesity. Recent studies demonstrate an association between increased metabolic activity of VAT, determined preoperatively by 18F-FDG PET/CT, with the presence of metastatic axillary lymph node involvement in postmenopausal patients with luminal breast cancer.
The current study is proposed during neoadjuvant treatment (NY), and aims to determine whether after an intervention in exercise and diet improves the quality of life of patients and tolerability to oncological treatment NY. In addition, the investigators will use 18F-FDG PET/CT as a marker of aggressiveness at diagnosis by quantifying the metabolic activity of VAT (SUVmax VAT, SULmax VAT and VAT/SAT ratio) and subsequently in the assessment of response to treatment. The investigators will also determine the response at the histopathological level of the tumor itself after the intervention (residual tumor burden (RCB), Ki 67, TNM) and at the level of inflammation-related parameters (TNF, IL6, CRP), which can influence the prognosis and the risk of local or distant recurrence in patients.
- Conditions
- Breast Cancer
- Being tested
- Nutritional intervention, Physical exercise intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional interventionBehavioural
The nutritional intervention will be based on a nutritional education program adapted for patients with breast cancer in active treatment. The nutritional intervention program will be based on the practical guidelines for nutrition in the oncology patient. The main objectives of the nutritional intervention will focus on preventing malnutrition, maintaining an adequate nutritional status and dietary adaptation to secondary symptomatology. To this end, an adequate energy and protein intake will be ensured and the consumption of plant-based foods will be promoted to ensure an adequate intake of vitamins, minerals and antioxidants
Physical exercise interventionBehavioural
Weekly physical exercise guidelines will be given following the published Canadian clinical guideline recommendations combining moderate and vigorous aerobic activity. Walking will be performed 3 days a week for 30 minutes at a modified Borg scale intensity of 4-5/10, and 2 days a week for 15 minutes at a modified Borg scale intensity of 7-8/10. There will also be 5 minutes of warm-up and 5 minutes of recovery, in moderate activity at 3/10, and in vigorous activity at 4/10. In addition, 3 days per week (not coinciding with vigorous aerobic activity) of strength training at a modified Borg scale intensity of 7/10 will be included. Two sets of 8-10 repetitions will be performed, adaptable to that intensity according to the progression of the subjec
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants randomized to receive the multimodal intervention (nutrition and exercise) Receives: Behavioral: Nutritional intervention; Behavioral: Physical exercise intervention |
| Control group | No intervention | Participants will not receive the multimodal intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant's quality of life
QLQ-CD30 test
Measured: 6 months
Participant's quality of life
BR23 test
Measured: 6 months
Body composition
Weight (kg)
Measured: 6 months
Body composition
Height (cm)
Measured: 6 months
Body composition
Circumferences (waist and hip; cm)
Measured: 6 months
Body composition
Fat mass (kg), visceral fat (g), lean mass (kg) and bone mineral content (g) will be evaluated by Dual Energy X-Ray Absorptiometry (Discovery Wi, Hologic Bedford, MA, USA) and 18F-FDG PET/CT
Measured: 6 months
Secondary outcomes (8)
Response rate
Response rate (%) determined by magnetic Resonance Imaging (MRI) and 18F-FDG PET/CT
Measured: 6 months
Analytical parameters
Inflammation parameters: to analyze the degree of inflammation the modified Glasgow Pronostic Score (mGPS) is used, which is nowadays considered an important predictive tool for morbidity and mortality in these patients by measuring serum albumin and CRP values. IL6 and TNF levels, measured in pg/ml, which will be determined in blood samples.
Measured: 6 months
Analytical parameters
Biochemical parameters: A routine analysis will be carried out in the Granada Hospital complex to determine biochemical parameters.
Measured: 6 months
Analytical parameters
Biochemical parameters: A routine analysis will be carried out in the Granada Hospital complex to determine tumor markers.
Measured: 6 months
Physical parameters
Muscle strength: By means of the manual grip test, completing two repetitions with each hand, with one minute between repetitions. A Takei 5401 Grip-D digital manual dynamometer (Takei, Tokyo, Japan) will be used.
Measured: 6 months
Physical parameters
PAR-7 survey (to evaluate the previous physical level of the patients, it will be carried out via telephone by a single interviewer for all the patients included)
Measured: 6 months
Emotional wellbeing
Beck Depression Inventory (BDI-II). Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe
Measured: 6 months
Nutritional assessment
food frequency questionnaire which will asess the consumption of different food groups and nutrients intake.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start15 Jan 2023
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves
- Responsible party
- Principal investigator, Lucas Jurado-Fasoli, Universidad de Granada
- Investigators
- Lucas J Jurado-Fasoli, Principal investigator, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656716
- Sponsor's protocol ID
- Multimodal Project
- Status last verified
- May 2024
- First submitted
- 27 Nov 2022
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Munoz-Lerma A, Sanchez-Sanchez R, Ruiz-Vozmediano J, Yebras Cano T, Gonzalez-Jimenez A, Jurado-Fasoli L. Effect of a multimodal intervention in breast Cancer patients undergoing neoadjuvant therapy: A study protocol of the multimodal project. Contemp Clin Trials. 2024 Aug;143:107598. doi: 10.1016/j.cct.2024.107598. Epub 2024 Jun 3.
PubMed 38838986
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multimodal Intervention on the Response to Neoadjuvant Therapy in Breast Cancer Patients.
- ClinicalTrials.gov ID
- NCT05656716
- Acronym / sponsor ID
- Multimodal Project
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University Hospital Virgen de las Nieves
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Dec 2022 (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.
The main aim of this study is to determine the effect of a multimodal intervention (Nutrition and Exercise) on quality of life, emotional well-being, and secondary symptomatology in patients diagnosed with breast cancer during neoadjuvant chemotherapy treatment, and to compare them with the control group.
Detailed description
Multiple studies have demonstrated the relationship between obesity, sedentary lifestyle and stress on the risk of developing various types of cancer, including breast cancer. The correlation between a high Body Mass Index (BMI) and a worse prognosis in patients already diagnosed with breast cancer has also been studied, as well as the tendency to gain weight during chemotherapy treatments. A low-fat dietary pattern has been associated with reduced mortality after a breast cancer diagnosis, through mechanisms that decrease the likelihood of developing metabolic syndrome and reduce estradiol levels. In recent years, the importance of healthy lifestyle habits in improving the quality of life of these patients has also been demonstrated.
Although BMI is an easy-to-obtain marker of obesity, it is a rather crude measure that does not fully reflect the dysfunctional activity of visceral fat (VAT), which appears to be a key pathophysiological mechanism determining the clinical and metabolic consequences of obesity. Recent studies demonstrate an association between increased metabolic activity of VAT, determined preoperatively by 18F-FDG PET/CT, with the presence of metastatic axillary lymph node involvement in postmenopausal patients with luminal breast cancer.
The current study is proposed during neoadjuvant treatment (NY), and aims to determine whether after an intervention in exercise and diet improves the quality of life of patients and tolerability to oncological treatment NY. In addition, the investigators will use 18F-FDG PET/CT as a marker of aggressiveness at diagnosis by quantifying the metabolic activity of VAT (SUVmax VAT, SULmax VAT and VAT/SAT ratio) and subsequently in the assessment of response to treatment. The investigators will also determine the response at the histopathological level of the tumor itself after the intervention (residual tumor burden (RCB), Ki 67, TNM) and at the level of inflammation-related parameters (TNF, IL6, CRP), which can influence the prognosis and the risk of local or distant recurrence in patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Nutritional intervention, Behavioral: Physical exercise interventionParticipants randomized to receive the multimodal intervention (nutrition and exercise) |
| Control group | No intervention | –Participants will not receive the multimodal intervention. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with breast cancer who will undergo neoadjuvant treatment in the Oncology Unit of the Virgen de las Nieves University Hospital of Granada.
- Aged between 18 and 75 years.
- Give their consent to participate in the study and commit to complete the entire intervention and attend their follow-up appointments.
- Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols
Key exclusion criteria (4 listed)
- Patients who are unwilling or unable to comply with the established guidelines by means of an intervention in diet and physical exercise and/or who present physical or psychological pathologies that contraindicate their inclusion in the study.
- Patients who do not register the data required for follow-up.
- Any condition that, in the investigator's opinion, impairs the ability to participate in the study or represents a personal risk for the participant.
- Are deemed unsuitable by the investigator for any other reason, that prevent data collection.
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 |
|---|---|---|
| Nutritional interventionThe nutritional intervention will be based on a nutritional education program adapted for patients with breast cancer in active treatment. The nutritional intervention program will be based on the practical guidelines for nutrition in the oncology patient. The main objectives of the nutritional intervention will focus on preventing malnutrition, maintaining an adequate nutritional status and dietary adaptation to secondary symptomatology. To this end, an adequate energy and protein intake will be ensured and the consumption of plant-based foods will be promoted to ensure an adequate intake of vitamins, minerals and antioxidants | Behavioural | Intervention group |
| Physical exercise interventionWeekly physical exercise guidelines will be given following the published Canadian clinical guideline recommendations combining moderate and vigorous aerobic activity. Walking will be performed 3 days a week for 30 minutes at a modified Borg scale intensity of 4-5/10, and 2 days a week for 15 minutes at a modified Borg scale intensity of 7-8/10. There will also be 5 minutes of warm-up and 5 minutes of recovery, in moderate activity at 3/10, and in vigorous activity at 4/10. In addition, 3 days per week (not coinciding with vigorous aerobic activity) of strength training at a modified Borg scale intensity of 7/10 will be included. Two sets of 8-10 repetitions will be performed, adaptable to that intensity according to the progression of the subjec | Behavioural | Intervention group |
Primary outcome
Participant's quality of life
Time frame: 6 months
QLQ-CD30 test
Participant's quality of life
Time frame: 6 months
BR23 test
Body composition
Time frame: 6 months
Weight (kg)
Body composition
Time frame: 6 months
Height (cm)
Body composition
Time frame: 6 months
Circumferences (waist and hip; cm)
Body composition
Time frame: 6 months
Fat mass (kg), visceral fat (g), lean mass (kg) and bone mineral content (g) will be evaluated by Dual Energy X-Ray Absorptiometry (Discovery Wi, Hologic Bedford, MA, USA) and 18F-FDG PET/CT
8 secondary outcomes
Response rate
Time frame: 6 months
Analytical parameters
Time frame: 6 months
Analytical parameters
Time frame: 6 months
Analytical parameters
Time frame: 6 months
Physical parameters
Time frame: 6 months
Physical parameters
Time frame: 6 months
Emotional wellbeing
Time frame: 6 months
Nutritional assessment
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 38838986Munoz-Lerma A, Sanchez-Sanchez R, Ruiz-Vozmediano J, Yebras Cano T, Gonzalez-Jimenez A, Jurado-Fasoli L. Effect of a multimodal intervention in breast Cancer patients undergoing neoadjuvant therapy: A study protocol of the multimodal project. Contemp Clin Trials. 2024 Aug;143:107598. doi: 10.1016/j.cct.2024.107598. Epub 2024 Jun 3.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Lucas J Jurado-Fasoli principal investigator
Universidad de Granada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutritional intervention and Physical exercise intervention in people with Breast Cancer, run by Universidad de Granada at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucas Jurado-Fasoli (618375662 ext. 34, juradofasoli@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant's quality of life (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05656716, which also lists 1 linked publication.
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 9 May 2024.