Breast Cancer SurvivorsNCT07275957
Combined Nutrition and Exercise Interventions in Women With Breast Cancer History
A study testing Mediterranean Diet Counseling, Supervised Strength Training Program and Supervised Endurance Training Program in people with Breast Cancer Survivors, run by University of Alicante at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Breast Cancer Survivors
- What is being tested?
- Mediterranean Diet Counseling, Supervised Strength Training Program and Supervised Endurance Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 30 to 65 years.
- Previous diagnosis of breast cancer (stages I-III) confirmed by medical records.
- Completion of primary oncological treatment (surgery, radiotherapy, chemotherapy, and/or hormone therapy) at least 3 months before enrollment.
- Absence of active cancer or evidence of recurrence.
- Medical clearance to perform physical exercise.
- Willingness to participate in dietary and/or exercise interventions for 12 weeks.
- Ability to attend evaluation and intervention sessions and comply with study procedures.
- Signed written informed consent.
Who cannot join
- Active cancer, metastasis, or ongoing chemotherapy or radiotherapy.
- Severe cardiovascular, respiratory, renal, hepatic, or metabolic disease that contraindicates exercise.
- Musculoskeletal or neurological conditions limiting participation in physical activity.
- Severe psychiatric disorders or cognitive impairment affecting adherence to the intervention.
- Current participation in another clinical trial or structured lifestyle intervention.
- Use of dietary supplements, appetite regulators, or pharmacological agents affecting metabolism during the study period.
- Pregnancy, breastfeeding, or intention to become pregnant during the study.
- Inability to comply with the intervention schedule or follow-up assessments.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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:
- Control group - no intervention.
- Mediterranean diet group (MD) - individualized nutritional plan based on Mediterranean dietary patterns.
- Strength training group (ST) - supervised resistance exercise sessions.
- Endurance training group (ET) - supervised aerobic exercise sessions.
- Combined training group (CT) - combination of strength and endurance training.
- 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.
- Conditions
- Breast Cancer Survivors
- Being tested
- Mediterranean Diet Counseling, Supervised Strength Training Program, Supervised Endurance Training Program, Combined Strength and Endurance Training Program, Combined Mediterranean Diet and Exercise Program
- Keywords
- Breast cancer survivors, Exercise intervention, Nutritional intervention, Mediterranean diet, Physical rehabilitation, Quality of life, Body composition, Strength training, Aerobic exercise, Combined training, Lifestyle modification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet CounselingBehavioural
Individualized nutritional counseling based on Mediterranean diet principles, emphasizing the intake of fruits, vegetables, legumes, whole grains, nuts, olive oil, and fish, while reducing red meat, processed foods, and added sugars. Sessions will be held biweekly to ensure adherence and promote long-term dietary behavior change.
Supervised Strength Training ProgramBehavioural
A structured resistance exercise program performed three times per week for 12 weeks. Each 60-minute session will include exercises for major muscle groups using elastic bands, dumbbells, or body weight, progressively increasing intensity to improve muscle strength and endurance.
Supervised Endurance Training ProgramBehavioural
A structured aerobic exercise program consisting of walking, cycling, or treadmill training three times per week for 12 weeks. Exercise intensity will range from 60% to 75% of the estimated maximal heart rate, progressively adjusted to enhance cardiovascular fitness and fatigue resistance.
Combined Strength and Endurance Training ProgramBehavioural
A combined exercise protocol including both resistance and aerobic components within each 60-70-minute session, three times per week for 12 weeks. Strength exercises will precede moderate-intensity aerobic work to improve overall physical performance and functional capacity.
Combined Mediterranean Diet and Exercise ProgramBehavioural
Comprehensive lifestyle intervention combining Mediterranean diet counseling with the supervised combined training program. Participants will receive individualized diet plans and attend three supervised exercise sessions per week. The intervention targets improvements in body composition, physical fitness, and emotional well-being.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Control Group | No intervention | Participants will not receive any specific dietary or exercise intervention. They will be asked to maintain their usual lifestyle and dietary habits during the 12-week study period. General health recommendations based on national guidelines will be provided at baseline. |
| Arm 2 - Mediterranean Diet Group (MD) | Experimental | Participants will receive individualized nutritional counseling promoting adherence to a Mediterranean dietary pattern, emphasizing fruits, vegetables, legumes, whole grains, olive oil, nuts, fish, and moderate dairy intake. Processed and high-sugar foods will be limited. Dietitians will provide personalized follow-up and adjustments every two weeks to ensure adherence. Receives: Behavioral: Mediterranean Diet Counseling |
| Arm 3 - Strength Training Group (ST) | Experimental | Participants will perform a 12-week supervised resistance training program focused on improving muscular strength and functional capacity. Sessions will be conducted three times per week, lasting approximately 60 minutes, and include major muscle groups using elastic bands, free weights, and bodyweight exercises. Training load will progressively increase according to individual capacity. Receives: Behavioral: Supervised Strength Training Program |
| Arm 4 - Endurance Training Group (ET) | Experimental | Participants will follow a structured aerobic exercise program consisting of walking, cycling, or treadmill sessions three times per week for 12 weeks. The intensity will be moderate (60-75% of estimated maximal heart rate), gradually progressing as tolerated. The goal is to enhance cardiorespiratory fitness and overall endurance. Receives: Behavioral: Supervised Endurance Training Program |
| Arm 5 - Combined Training Group (CT) | Experimental | Participants will perform both strength and aerobic training during the 12-week intervention. Each session (3 per week, 60-70 minutes) will include resistance exercises targeting major muscle groups followed by aerobic activity at moderate intensity. The program aims to improve both muscular and cardiovascular performance synergistically. Receives: Behavioral: Combined Strength and Endurance Training Program |
| Arm 6 - Mediterranean Diet plus Combined Training Group (MD+CT) | Experimental | Participants will simultaneously receive the Mediterranean Diet counseling and participate in the Combined Training program for 12 weeks. The objective is to assess the synergistic effects of diet and exercise on physical, physiological, and psychological health in breast cancer survivors. Receives: Behavioral: Combined Mediterranean Diet and Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fat-Free Mass (kg)
To evaluate changes in fat-free mass after the 12-week intervention, measured by bioimpedance analysis (BIODY XPERT ZM).
Measured: Baseline and Week 12
Secondary outcomes (21)
Change in Fat Mass (%)
To assess changes in total body fat percentage using bioimpedance analysis.
Measured: Baseline and Week 12
Change in Body Weight (kg)
To determine body weight variation during the 12-week intervention.
Measured: Baseline and Week 12
Change in Body Mass Index (kg/m²)
To evaluate changes in BMI calculated as weight divided by height squared.
Measured: Baseline and Week 12
Change in Waist Circumference (cm)
To assess central adiposity changes by measuring waist circumference.
Measured: Baseline and Week 12
Change in Handgrip Strength (kg)
To evaluate upper-body muscular strength using a digital hand dynamometer.
Measured: Baseline and Week 12
Change in Lower-Limb Strength (kg)
To assess lower-limb strength through isometric tests using a load cell or force platform.
Measured: Baseline and Week 12
Change in Functional Capacity (6-Minute Walk Test Distance, m)
To evaluate cardiorespiratory endurance using the 6-minute walk test.
Measured: Baseline and Week 12
Change in Balance Performance
To assess dynamic balance and postural control
Measured: Baseline and Week 12
Change in Flexibility (Sit-and-Reach Test, cm)
To evaluate flexibility of the posterior chain through the sit-and-reach test.
Measured: Baseline and Week 12
Change in Maximal Oxygen Uptake (VO₂max, mL/kg/min)
To determine changes in aerobic capacity using an incremental treadmill test with indirect calorimetry (METALYZ-ERR 3 B-R3 spirometer).
Measured: Baseline and Week 12
Change in Total Cholesterol (mg/dL)
To evaluate lipid profile variations by measuring total cholesterol concentration.
Measured: Baseline and Week 12
Change in HDL Cholesterol (mg/dL)
To assess cardioprotective lipid changes.
Measured: Baseline and Week 12
Change in LDL Cholesterol (mg/dL)
To measure changes in LDL cholesterol levels.
Measured: Baseline and Week 12
Change in Triglycerides (mg/dL)
To determine variations in triglyceride concentration.
Measured: Baseline and Week 12
Change in Fasting Glucose (mg/dL)
To assess metabolic health by measuring fasting plasma glucose.
Measured: Baseline and Week 12
Change in C-Reactive Protein (mg/L)
To evaluate systemic inflammation using CRP levels.
Measured: Baseline and Week 12
Change in Interleukin-6 (pg/mL)
To measure inflammatory status via IL-6 concentration.
Measured: Baseline and Week 12
Change in Fatigue (FACIT-F Questionnaire Score)
Description: Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F). This questionnaire consists of 13 items rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very much"), reflecting fatigue experienced during the past 7 days. The total score is calculated by summing the item scores (after reverse scoring where applicable). Range: 0-52. Interpretation: Higher scores indicate less fatigue and therefore a better functional status, while lower scores reflect greater fatigue severity.
Measured: Baseline and Week 12
Change in Sleep Quality (PSQI Total Score)
Description: Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-reported questionnaire that evaluates sleep quality and disturbances over the previous month. The items are grouped into seven components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction), each scored from 0 to 3. The global PSQI score is the sum of the components (range 0-21). Range: 0-21. Interpretation: Higher scores indicate poorer sleep quality.
Measured: Baseline and Week 12
Change in Physical Activity Level (IPAQ Total Score)
Description: Physical activity levels will be evaluated using the International Physical Activity Questionnaire - Short Form (IPAQ-SF), which records the frequency and duration of walking, moderate, and vigorous activities over the past 7 days. The results are expressed as total metabolic equivalent minutes per week (MET-min/week) and can be categorized into three levels: low, moderate, or high activity. Range: 0 to unlimited MET-min/week. Interpretation: Higher scores indicate higher physical activity levels.
Measured: Baseline and Week 12
Change in Dietary Adherence (Mediterranean Diet Adherence Screener Score)
Description: Adherence to the Mediterranean diet will be assessed using the PREDIMED Questionnaire, a validated 14-item questionnaire evaluating key dietary habits such as olive oil use, fruit and vegetable consumption, fish intake, and limitation of red meat and sweets. Each affirmative answer scores 1 point, yielding a total score from 0 (minimal adherence) to 14 (maximal adherence). Range: 0-14. Interpretation: Higher scores indicate better adherence to the Mediterranean dietary pattern.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Sep 2023
- Primary completion31 Dec 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of six parallel intervention arms (control, Mediterranean diet, strength training, endurance training, combined training, or Mediterranean diet plus combined training). The interventions will be carried out simultaneously over 12 weeks, with pre- and post-intervention assessments to evaluate changes in physical, physiological, and psychological parameters.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alicante
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Alejandro Martínez-Rodríguez, University of Alicante
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07275957
- Sponsor's protocol ID
- UA-2025-06-13
- Status last verified
- Feb 2026
- First submitted
- 25 Nov 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07275957
- Acronym / sponsor ID
- UA-2025-06-13
- Conditions
- Breast Cancer Survivors
- Keywords
- Breast cancer survivors, Exercise intervention, Nutritional intervention, Mediterranean diet, Physical rehabilitation, Quality of life, Body composition, Strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of AlicanteUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Control group - no intervention.
- Mediterranean diet group (MD) - individualized nutritional plan based on Mediterranean dietary patterns.
- Strength training group (ST) - supervised resistance exercise sessions.
- Endurance training group (ET) - supervised aerobic exercise sessions.
- Combined training group (CT) - combination of strength and endurance training.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
- Model description
- Participants will be randomly assigned to one of six parallel intervention arms (control, Mediterranean diet, strength training, endurance training, combined training, or Mediterranean diet plus combined training). The interventions will be carried out simultaneously over 12 weeks, with pre- and post-intervention assessments to evaluate changes in physical, physiological, and psychological parameters.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Control Group | No intervention | –Participants will not receive any specific dietary or exercise intervention. They will be asked to maintain their usual lifestyle and dietary habits during the 12-week study period. General health recommendations based on national guidelines will be provided at baseline. |
| Arm 2 - Mediterranean Diet Group (MD) | Experimental | Behavioral: Mediterranean Diet CounselingParticipants will receive individualized nutritional counseling promoting adherence to a Mediterranean dietary pattern, emphasizing fruits, vegetables, legumes, whole grains, olive oil, nuts, fish, and moderate dairy intake. Processed and high-sugar foods will be limited. Dietitians will provide personalized follow-up and adjustments every two weeks to ensure adherence. |
| Arm 3 - Strength Training Group (ST) | Experimental | Behavioral: Supervised Strength Training ProgramParticipants will perform a 12-week supervised resistance training program focused on improving muscular strength and functional capacity. Sessions will be conducted three times per week, lasting approximately 60 minutes, and include major muscle groups using elastic bands, free weights, and bodyweight exercises. Training load will progressively increase according to individual capacity. |
| Arm 4 - Endurance Training Group (ET) | Experimental | Behavioral: Supervised Endurance Training ProgramParticipants will follow a structured aerobic exercise program consisting of walking, cycling, or treadmill sessions three times per week for 12 weeks. The intensity will be moderate (60-75% of estimated maximal heart rate), gradually progressing as tolerated. The goal is to enhance cardiorespiratory fitness and overall endurance. |
| Arm 5 - Combined Training Group (CT) | Experimental | Behavioral: Combined Strength and Endurance Training ProgramParticipants will perform both strength and aerobic training during the 12-week intervention. Each session (3 per week, 60-70 minutes) will include resistance exercises targeting major muscle groups followed by aerobic activity at moderate intensity. The program aims to improve both muscular and cardiovascular performance synergistically. |
| Arm 6 - Mediterranean Diet plus Combined Training Group (MD+CT) | Experimental | Behavioral: Combined Mediterranean Diet and Exercise ProgramParticipants will simultaneously receive the Mediterranean Diet counseling and participate in the Combined Training program for 12 weeks. The objective is to assess the synergistic effects of diet and exercise on physical, physiological, and psychological health in breast cancer survivors. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women aged 30 to 65 years.
- Previous diagnosis of breast cancer (stages I-III) confirmed by medical records.
- Completion of primary oncological treatment (surgery, radiotherapy, chemotherapy, and/or hormone therapy) at least 3 months before enrollment.
- Absence of active cancer or evidence of recurrence.
- Medical clearance to perform physical exercise.
Key exclusion criteria (8 listed)
- Active cancer, metastasis, or ongoing chemotherapy or radiotherapy.
- Severe cardiovascular, respiratory, renal, hepatic, or metabolic disease that contraindicates exercise.
- Musculoskeletal or neurological conditions limiting participation in physical activity.
- Severe psychiatric disorders or cognitive impairment affecting adherence to the intervention.
- Current participation in another clinical trial or structured lifestyle intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean Diet CounselingIndividualized nutritional counseling based on Mediterranean diet principles, emphasizing the intake of fruits, vegetables, legumes, whole grains, nuts, olive oil, and fish, while reducing red meat, processed foods, and added sugars. Sessions will be held biweekly to ensure adherence and promote long-term dietary behavior change. | Behavioural | Arm 2 - Mediterranean Diet Group (MD) |
| Supervised Strength Training ProgramA structured resistance exercise program performed three times per week for 12 weeks. Each 60-minute session will include exercises for major muscle groups using elastic bands, dumbbells, or body weight, progressively increasing intensity to improve muscle strength and endurance. | Behavioural | Arm 3 - Strength Training Group (ST) |
| Supervised Endurance Training ProgramA structured aerobic exercise program consisting of walking, cycling, or treadmill training three times per week for 12 weeks. Exercise intensity will range from 60% to 75% of the estimated maximal heart rate, progressively adjusted to enhance cardiovascular fitness and fatigue resistance. | Behavioural | Arm 4 - Endurance Training Group (ET) |
| Combined Strength and Endurance Training ProgramA combined exercise protocol including both resistance and aerobic components within each 60-70-minute session, three times per week for 12 weeks. Strength exercises will precede moderate-intensity aerobic work to improve overall physical performance and functional capacity. | Behavioural | Arm 5 - Combined Training Group (CT) |
| Combined Mediterranean Diet and Exercise ProgramComprehensive lifestyle intervention combining Mediterranean diet counseling with the supervised combined training program. Participants will receive individualized diet plans and attend three supervised exercise sessions per week. The intervention targets improvements in body composition, physical fitness, and emotional well-being. | Behavioural | Arm 6 - Mediterranean Diet plus Combined Training Group (MD+CT) |
Primary outcome
Change in Fat-Free Mass (kg)
Time frame: Baseline and Week 12
To evaluate changes in fat-free mass after the 12-week intervention, measured by bioimpedance analysis (BIODY XPERT ZM).
21 secondary outcomes
Change in Fat Mass (%)
Time frame: Baseline and Week 12
Change in Body Weight (kg)
Time frame: Baseline and Week 12
Change in Body Mass Index (kg/m²)
Time frame: Baseline and Week 12
Change in Waist Circumference (cm)
Time frame: Baseline and Week 12
Change in Handgrip Strength (kg)
Time frame: Baseline and Week 12
Change in Lower-Limb Strength (kg)
Time frame: Baseline and Week 12
Change in Functional Capacity (6-Minute Walk Test Distance, m)
Time frame: Baseline and Week 12
Change in Balance Performance
Time frame: Baseline and Week 12
Change in Flexibility (Sit-and-Reach Test, cm)
Time frame: Baseline and Week 12
Change in Maximal Oxygen Uptake (VO₂max, mL/kg/min)
Time frame: Baseline and Week 12
Change in Total Cholesterol (mg/dL)
Time frame: Baseline and Week 12
Change in HDL Cholesterol (mg/dL)
Time frame: Baseline and Week 12
Change in LDL Cholesterol (mg/dL)
Time frame: Baseline and Week 12
Change in Triglycerides (mg/dL)
Time frame: Baseline and Week 12
Change in Fasting Glucose (mg/dL)
Time frame: Baseline and Week 12
Change in C-Reactive Protein (mg/L)
Time frame: Baseline and Week 12
Change in Interleukin-6 (pg/mL)
Time frame: Baseline and Week 12
Change in Fatigue (FACIT-F Questionnaire Score)
Time frame: Baseline and Week 12
Change in Sleep Quality (PSQI Total Score)
Time frame: Baseline and Week 12
Change in Physical Activity Level (IPAQ Total Score)
Time frame: Baseline and Week 12
Change in Dietary Adherence (Mediterranean Diet Adherence Screener Score)
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mediterranean Diet Counseling, Supervised Strength Training Program and Supervised Endurance Training Program in people with Breast Cancer Survivors, run by University of Alicante at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fat-Free Mass (kg) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.