Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-25 @ 4:24 PM
Study NCT ID:
NCT07275957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-10
First Post:
2025-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Nutrition and Exercise Interventions in Women With Breast Cancer History
Sponsor:
University of Alicante
Organization:
Study Overview
Official Title:
Study of the Effects of Implementing Dietary-nutritional Strategies and an Exercise Program at the Physical, Physiological, and Psychological Level in Women With a History of Breast Cancer.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to evaluate the effects of a combined dietary-nutritional and physical exercise intervention on physical, physiological, and psychological outcomes in women who are breast cancer survivors. Participants will be randomly assigned to different intervention groups involving dietary modification, exercise training, or their combination, compared to a control group. The program will last 12 weeks and will include pre- and post-intervention assessments of body composition, metabolic parameters, functional capacity, and quality of life.
The primary goal is to assess improvements in physical fitness, body composition, and emotional well-being, as well as to identify potential synergistic effects of combined interventions in this population.
The primary goal is to assess improvements in physical fitness, body composition, and emotional well-being, as well as to identify potential synergistic effects of combined interventions in this population.
Detailed Description:
Breast cancer survivors often experience long-term physical and psychological side effects derived from treatment, such as fatigue, loss of muscle mass, metabolic alterations, and reduced quality of life. Lifestyle interventions involving nutrition and exercise have demonstrated significant potential to mitigate these effects and promote overall recovery.
This randomized controlled clinical trial will include adult female breast cancer survivors who have completed their primary oncological treatment. Participants will be divided into six parallel groups:
1. Control group - no intervention.
2. Mediterranean diet group (MD) - individualized nutritional plan based on Mediterranean dietary patterns.
3. Strength training group (ST) - supervised resistance exercise sessions.
4. Endurance training group (ET) - supervised aerobic exercise sessions.
5. Combined training group (CT) - combination of strength and endurance training.
6. Combined diet and exercise group (MD+CT) - simultaneous application of Mediterranean diet and combined training.
The intervention will last 12 weeks, during which participants in the intervention groups will attend supervised sessions and receive continuous nutritional guidance. Assessments will be performed at baseline and after 12 weeks, including anthropometric and body composition analysis, metabolic and inflammatory markers, physical fitness testing, dietary intake, and psychological well-being scales.
This study seeks to identify the most effective strategy-dietary, physical, or combined-for improving health outcomes, functionality, and emotional recovery in breast cancer survivors, contributing to the development of comprehensive post-treatment rehabilitation programs.
This randomized controlled clinical trial will include adult female breast cancer survivors who have completed their primary oncological treatment. Participants will be divided into six parallel groups:
1. Control group - no intervention.
2. Mediterranean diet group (MD) - individualized nutritional plan based on Mediterranean dietary patterns.
3. Strength training group (ST) - supervised resistance exercise sessions.
4. Endurance training group (ET) - supervised aerobic exercise sessions.
5. Combined training group (CT) - combination of strength and endurance training.
6. Combined diet and exercise group (MD+CT) - simultaneous application of Mediterranean diet and combined training.
The intervention will last 12 weeks, during which participants in the intervention groups will attend supervised sessions and receive continuous nutritional guidance. Assessments will be performed at baseline and after 12 weeks, including anthropometric and body composition analysis, metabolic and inflammatory markers, physical fitness testing, dietary intake, and psychological well-being scales.
This study seeks to identify the most effective strategy-dietary, physical, or combined-for improving health outcomes, functionality, and emotional recovery in breast cancer survivors, contributing to the development of comprehensive post-treatment rehabilitation programs.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: