RecruitingNot ApplicableNCT05656716

Multimodal Project

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


Sponsor

Universidad de Granada

Enrollment

80 participants

Start Date

Jan 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a structured program combining dietary changes, supervised physical exercise, and psychosocial support during neoadjuvant chemotherapy (chemo given before surgery) improves quality of life and treatment outcomes for women recently diagnosed with breast cancer in Granada, Spain. **You may be eligible if...** - You have been diagnosed with breast cancer and are scheduled for neoadjuvant treatment at the Virgen de las Nieves University Hospital in Granada - You are between 18 and 75 years old - You are willing and able to follow the program's diet and exercise guidelines throughout the study - You are able to attend all required follow-up appointments **You may NOT be eligible if...** - You are unwilling or unable to follow the prescribed dietary changes and physical activity guidelines - You have physical or psychological conditions that make the exercise or dietary program unsafe - You are unable to attend required follow-up visits or complete required data collection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNutritional 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

BEHAVIORALPhysical 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


Locations(1)

University of Granada

Granada, Spain

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NCT05656716


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