Clinical trial · Interventional
Multimodal Project
Effect of a Multimodal Intervention on the Response to Neoadjuvant Therapy in Breast Cancer Patients.
NCT05656716CI-TRIAL-00076951unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nutritional intervention | Behavioral | — | UNRESOLVED |
| Physical exercise intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Participants randomized to receive the multimodal intervention (nutrition and exercise)
- interventionNames
- Behavioral: Nutritional intervention
- Behavioral: Physical exercise intervention
- type
- NO_INTERVENTION
- label
- Control group
- description
- Participants will not receive the multimodal intervention.
Primary outcomes (6)
- measure
- Participant's quality of life
- timeFrame
- 6 months
- description
- QLQ-CD30 test
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDMunoz-Lerma A, Sanchez-Sanchez R, Ruiz-Vozmediano J, Yebras Cano T, Gonzalez-Jimenez A, Jurado-Fasoli L. Effect of a multimodal intervention in breast Cancer patients undergoing neoadjuvant therapy: A study protocol of the multimodal project. Contemp Clin Trials. 2024 Aug;143:107598. doi: 10.1016/j.cct.2024.107598. Epub 2024 Jun 3. PMID 38838986