Multimodal intervention for breast cancer patients during chemotherapy
Effect of a Multimodal Intervention on the Response to Neoadjuvant Therapy in Breast Cancer Patients.
NA · Universidad de Granada · NCT05656716
This study is testing if a combination of nutrition and exercise can help breast cancer patients feel better and manage symptoms during chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Universidad de Granada (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Granada) |
| Trial ID | NCT05656716 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of a multimodal intervention combining nutrition and exercise on the quality of life, emotional well-being, and secondary symptoms in patients diagnosed with breast cancer undergoing neoadjuvant chemotherapy. It will compare the outcomes of participants receiving the intervention with those in a control group. The study is based on the premise that lifestyle changes can positively influence treatment tolerability and overall health during chemotherapy. Participants will be monitored for adherence to the intervention and its impact on their health metrics.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients aged 18 to 75 who are about to start neoadjuvant chemotherapy and can commit to the intervention.
Not a fit: Patients with physical or psychological conditions that prevent them from participating in diet and exercise interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and treatment experience for breast cancer patients undergoing chemotherapy.
How similar studies have performed: Previous studies have shown promising results with lifestyle interventions in cancer care, indicating potential success for this multimodal approach.
Eligibility criteria
Show full inclusion / exclusion 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. * 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.
Where this trial is running
Granada
- University of Granada — Granada, Spain (RECRUITING)
Study contacts
- Principal investigator: Lucas J Jurado-Fasoli — Universidad de Granada
- Study coordinator: Lucas Jurado-Fasoli
- Email: juradofasoli@ugr.es
- Phone: 618375662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer