NCT05656716

Multimodal Project

Effect of a Multimodal Intervention on the Response to Neoadjuvant Therapy in Breast Cancer Patients.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Universidad de Granada · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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
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

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-08-01
• Completion: 2024-09-01
• First posted: 2022-12-19
• Last updated: 2024-05-09

Locations

1 site across 1 country: Spain