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L'essai clinique NCT06322888 pour Cancer du sein, Cancer du sein chez la femme est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
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L'étude clinique NCT06322888 est un essai interventionnel pour Cancer du sein, Cancer du sein chez la femme. Son statut actuel est : en recrutement. L'étude a débuté le 28 mars 2024 et vise à recruter 46 participants. Dirigé par Dana-Farber Cancer Institute, l'essai devrait être terminé d'ici le 31 décembre 2026. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 21 novembre 2025.
Résumé succinct
The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer in women with dense breast tissue by studying changes that occur in breast tissue and blood as a result of participating in an exercise program.
The names of the study groups in this study are:
- Exercise Training Group
- Waitlist Control Group
Description détaillée
The goal of this study is to learn more about how exercise might lower the risk of developing breast cancer by studying changes that occur in breast tissue and blood as a result of participating in an exercise program. Participants will be placed into one of two study groups: Exercise Training Group vs. Waitlist Control Group. Randomization means that a participant is put into a group by chance.
The research study procedures include screening for eligibility and baseline and end of study assessments which include: breast biopsies, assessment of physical activity habits, aerobic and strength testing, blood draws and questionnaires.
Participants randomized to the exercise group will be expected to participate in exercise sessions throughout the study. They will also be asked to complete logs of their activity.
Participants will be in this research study for up to 16 weeks.
It is expected that 46 women will take part in this study.
The Breast Cancer Research Foundation is supporting this research study by providing funding.
Titre officiel
Resistance and Aerobic Exercise for Prevention in Women With Dense Breasts (REP-D)
Conditions
Cancer du seinCancer du sein chez la femmeAutres identifiants de l'essai
- 23-676
Numéro NCT
Date de début (réel)
2024-03-28
Dernière mise à jour publiée
2025-11-21
Date de fin (estimée)
2026-12-31
Inscription (estimée)
46
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Breast Cancer
Breast Cancer Female
Breast Cancer Risk
Dense breast tissue
Dense breasts
Breast Cancer Female
Breast Cancer Risk
Dense breast tissue
Dense breasts
Objectif principal
Prévention
Plan d'attribution
Randomisé
Modèle d'intervention
Parallèle
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalArm A: Exercise Intervention Participants will be randomized and will complete:
* Baseline study visit with assessments, breast biopsy, and blood draw.
* Exercise program for 12 weeks 3x weekly and exercise logs. Additional blood draw after first exercise session.
* End of study visit with assessments, breast biopsy, and blood draw. | Programme d'entraînement physique A 12-week aerobic and resistance-training exercise intervention with a certified exercise trainer in person or virtually. FitBit activity tracker, resistance bands, hand weights, and stationary bike will be provided to participants. Hand weights will be returned at end of study. |
Aucune interventionArm B: Waitlist Control Participants will be randomized and will complete:
* Baseline study visit with assessments, breast biopsy, and blood draw.
* End of study visit with assessments, breast biopsy, and blood draw.
* Participants will be offered a complimentary 12-week exercise program after completing the study. | N/A |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in Irisin in Exercise Group | Change in circulating irisin at baseline, after 1st exercise session, and end of study in exercise group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski. | At baseline, within 2 hours of 1st exercise session, and at week 12, up to 16 weeks |
Change in Irisin in Control Group | Change in circulating irisin at baseline and end of study in control group, and it will be compared using Wilcoxon rank-sum testing. Irisin will be measured by Parallel Reaction Monitoring in the Spiegelman Lab, using the method described by Jedrychowski. | At baseline and week 12, up to 16 weeks |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in Tissue Markers in Exercise Group | Immunofluorescence analysis of immune and proliferative markers from biopsies of benign breast tissue will be assessed through C-detection by indexing (CODEX) imaging for the exercise group and will be compared between treatments using Wilcoxon rank-sum testing. Imaging to be performed by the Molecular Imaging Core (MIC) at Dana-Farber Cancer Institute. | At baseline and week 12, up to 16 weeks |
Change in Tissue Markers in Control Group | Immunofluorescence analysis of immune and proliferative markers from biopsies of benign breast tissue will be assessed through C-detection by indexing (CODEX) imaging for the exercise group and will be compared between treatments using Wilcoxon rank-sum testing. Imaging to be performed by the Molecular Imaging Core (MIC) at Dana-Farber Cancer Institute. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Exercise Group - Meso scale | Assessed by assays for inflammatory mediators and will be performed using a Meso Scale Discovery multi-plex analysis system and will be conducted by the Translational Research Laboratory at Dana-Farber Cancer Institute. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Exercise Group - Mass cytometry | Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Control Group - Meso Scale | Assessed by assays for inflammatory mediators and will be performed using a Meso Scale Discovery multi-plex analysis system and will be conducted by the Translational Research Laboratory at Dana-Farber Cancer Institute. Additionally, Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments. | At baseline and week 12, up to 16 weeks |
Change in Biomarkers in Control Group - Mass cytometry | Mass cytometry (CyTOF) will be used to evaluate a panel of immune mediators and will be performed in conjunction with the Polyak Laboratory. Wilcoxon rank-sum testing will be used to compare between treatments. | At baseline and week 12, up to 16 weeks |
Change in Participant Weight in Exercise Group | Defined as the percent change in weight for Exercise Group from pretreatment to week 12 will be calculated, summarized, and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Participant Weight in Control Group | Defined as the percent change in weight for Control Group from pretreatment to week 12 will be calculated, summarized, and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Cardiorespiratory Fitness in Exercise Group | Assessed by VO2 max (i.e., the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)), measured using the Sub-Maximal Cycle Ergometer Test, will be calculated and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Cardiorespiratory Fitness in Control Group | Assessed by VO2 max (i.e., the number of milliliters of oxygen used per kilogram of body weight in one minute (ml/kg/min)), measured using the Sub-Maximal Cycle Ergometer Test, will be calculated and compared using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
10-Repetition Max Test in Exercise Group | The 10-Repetition Max Test is defined as the heaviest weight a participants could lift for 10 repetitions. Change and relative percent change will be calculated and compared between treatments using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
10-Repetition Max Test in Control Group | The 10-Repetition Max Test is defined as the heaviest weight a participants could lift for 10 repetitions. Change and relative percent change will be calculated and compared between treatments using Wilcoxon rank-sum testing. | At baseline and week 12, up to 16 weeks |
Change in Minutes of Total Exercise for Exercise Group | Change in minutes of total exercise and met hours per week (7-day par) will be calculated and compared between treatments using Wilcoxon rank-sum testing. The proportion of participants that achieve 150 minutes of exercise per week by 12 weeks will be compared using Wilcoxon rank-sum testing and Fisher's exact tests. | Up to 16 weeks |
Change in Minutes of Total Exercise for Control Group | Change in minutes of total exercise and met hours per week (7-day par) will be calculated and compared between treatments using Wilcoxon rank-sum testing. The proportion of participants that achieve 150 minutes of exercise per week by 12 weeks will be compared using Wilcoxon rank-sum testing and Fisher's exact tests. | Up to 16 weeks |
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Femme
Accepte les volontaires en bonne santé
Oui
- Women aged 18-59
- Heterogeneously dense/extremely dense (BIRADS 3 or 4) breast tissue on mammogram within the past 12 months
- Physically inactive; engaging in <60 minutes of moderate or vigorous intensity exercise per week, as assessed by Godin Leisure Time screener
- Not pregnant or breastfeeding
- English speaking and able to read English. Investigators are only enrolling English-speaking participants to this study at this time due to the fact that investigators currently only have English-speaking exercise trainers with the proper qualifications to conduct the exercise training
- Written informed consent prior to any study-related procedures
- Self-reported inability to walk 2 blocks (at any pace)
- Prior history of breast cancer; prior DCIS is allowable as long as participant is not taking endocrine therapy and has at least 1 breast that has not been irradiated
- On oral or implantable hormonal contraceptives, postmenopausal hormone replacement therapy, a selective estrogen receptor modulator or an aromatase inhibitor; Mirena or other IUD is acceptable
- Consistent strength training in the past 3 months
- Use of weightloss drugs
- Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate exercise. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility
- Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)
Dana-Farber Cancer InstituteBreast Cancer Research FoundationPartie responsable de l'essai
Jennifer A. Ligibel, MD, Investigateur principal, Principal Investigator, Dana-Farber Cancer Institute
Contact central de l'essai
Contact: Jennifer Ligibel, MD, 617-632-3800, [email protected]
Contact: Anna Tanasijevic, MPH, 617-632-5584, [email protected]
2 Centres de l'essai dans 1 pays
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States
Actif, pas en recrutement
Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States
Jennifer Ligibel, MD, Contact, 617-632-3800, [email protected]
Jennifer Ligibel, MD, Investigateur principal
En recrutement