Multimodal Project

NCT ID: NCT05656716

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2024-09-30

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Participants randomized to receive the multimodal intervention (nutrition and exercise)

Group Type: EXPERIMENTAL

Nutritional intervention

Intervention Type: BEHAVIORAL

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 intervention

Intervention Type: BEHAVIORAL

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

Control group

Participants will not receive the multimodal intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nutritional intervention

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

Intervention Type: BEHAVIORAL

Physical exercise intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Virgen de las Nieves

OTHER

Sponsor Role: collaborator

Universidad de Granada

OTHER

Sponsor Role: lead

Responsible Party

Lucas Jurado-Fasoli

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lucas J Jurado-Fasoli

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

University of Granada

Granada, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Lucas Jurado-Fasoli

Role: CONTACT

juradofasoli@ugr.es

618375662 ext. 34

Facility Contacts

Lucas Jurado-Fasoli, PhD

Role: primary

Other Identifiers

Multimodal Project

Identifier Type: -

Identifier Source: org_study_id