Multimodal Project
Effect of a Multimodal Intervention on the Response to Neoadjuvant Therapy in Breast Cancer Patients.
Universidad de Granada
80 participants
Jan 15, 2023
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
Inclusion Criteria3
- 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 Criteria4
- 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.
Interventions
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
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)
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NCT05656716