Breast Cancer Clinical Trial
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | 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. - Participant must be capable and willing to provide consent, understand exclusion criteria, instructions and protocols 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. |
Country | Name | City | State |
---|---|---|---|
Spain | University of Granada | Granada |
Lead Sponsor | Collaborator |
---|---|
Universidad de Granada | University Hospital Virgen de las Nieves |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant's quality of life | QLQ-CD30 test | 6 months | |
Primary | Participant's quality of life | BR23 test | 6 months | |
Primary | Body composition | Weight (kg) | 6 months | |
Primary | Body composition | Height (cm) | 6 months | |
Primary | Body composition | Circumferences (waist and hip; cm) | 6 months | |
Primary | 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 | 6 months | |
Secondary | Response rate | Response rate (%) determined by magnetic Resonance Imaging (MRI) and 18F-FDG PET/CT | 6 months | |
Secondary | 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. | 6 months | |
Secondary | Analytical parameters | Biochemical parameters: A routine analysis will be carried out in the Granada Hospital complex to determine biochemical parameters. | 6 months | |
Secondary | Analytical parameters | Biochemical parameters: A routine analysis will be carried out in the Granada Hospital complex to determine tumor markers. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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) | 6 months | |
Secondary | 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 | 6 months | |
Secondary | Nutritional assessment | food frequency questionnaire which will asess the consumption of different food groups and nutrients intake. | 6 months |
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