Beta
Trial Radar KI
enums.trial_summary.trial_summary_welcome
Eine Studie entspricht den Filterkriterien
Kartenansicht

Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue

Aktiv, nicht rekrutierend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT03657628 ist eine interventionsstudie zur Untersuchung von Brustkrebs und hat den Status aktiv, nicht rekrutierend. Die Studie startete am 17. September 2018 und soll 60 Teilnehmer aufnehmen. Durchgeführt von Dana-Farber Cancer Institute ist der Abschluss für 31. Dezember 2026 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 24. November 2025 aktualisiert.
Kurzbeschreibung
This research study is evaluating the effect of exercise on markers in breast tissue and blood of premenopausal women who have been found to have dense breast tissue on mammogram.
Ausführliche Beschreibung
Women who exercise regularly have a lower risk of developing breast cancer, but the processes through which exercise could make cancer less likely to occur are not known. Some research in animals has shown that exercise can slow the growth of breast cancer cells and may increase the body's own defense mechanisms by stimulating the immune system. Very little is known about the effects of exercise on breast tissue in people. Understanding what changes occur in breast tissue and related markers in blood when a woman begins to exercise could provide more information about the ways in which exercise could prevent breast cancer.

The study is designed to look at the changes that occur in markers found in breast tissue and blood in women with dense breast tissue who take part in an exercise program. Density of breast tissue is a measure of how much of the breast tissue is made up of cells rather than fat. Breast density on mammogram has been linked to the risk of developing breast cancer, with women with higher degrees of breast density having a higher risk of developing breast cancer compared to women whose breasts are less dense.

Since the investigators do not know if these blood or breast tissue tests have any relationship to the development of breast cancer, the investigators do not plan to share the results of these tests with the participant or its physician. The investigators will give the participants the option of receiving the overall study results when the trial is completed, if the participant would like to receive them.

Offizieller Titel

Pilot Study of the Impact of a Physical Activity Intervention on Proliferation and Immune Markers in Benign Breast Tissue in Women With High Mammographic Breast Density

Erkrankungen
Brustkrebs
Weitere Studien-IDs
NCT-Nummer
Studienbeginn (tatsächlich)
2018-09-17
Zuletzt aktualisiert
2025-11-24
Studienende (vorauss.)
2026-12-31
Geplante Rekrutierung
60
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Aktiv, nicht rekrutierend
Stichwörter
Breast Cancer
Primäres Ziel
Prävention
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellPhysical activity
* The exercise intervention will consist of a supervised, moderate-intensity aerobic exercise program. * Will receive social/behavioral support * Will receive research staff contact time to encourage them to increase their physical activity level * The participants will be given the option of a third supervised session each week
Bewegungsintervention
Strength training and moderate-intensity, aerobic exercise
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Impact of exercise upon expression of Ki-67
To evaluate the change in breast tissue expression of Ki-67 in premenopausal women with increased breast density taking part in a 12-week physical activity intervention
12-weeks
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Changes in biomarker (IL-6)
12-weeks
Changes in biomarker (TNF-a)
12-weeks
Changes in biomarker (CRP)
12-weeks
Changes in minutes of weekly physical activity
7-Day Physical Activity Recall Interview
12-weeks
Changes in waist to hip ratio
12-weeks
Changes in weight (% change)
12-weeks
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja
  • Written informed consent prior to any study-related procedures
  • Premenopausal women, defined as:
  • having regular menstrual cycles
  • age ≤ 50 years with an intact IUD
  • history of hysterectomy without oophorectomy
  • Heterogeneously dense or very dense (BIRADS 3 or 4) breast tissue on mammogram within the last 3 years
  • Physically inactive; engaging in <90 minutes of moderate or vigorous intensity PA per week
  • No prior history of breast cancer
  • At least 18 years old
  • Physically able to exercise
  • English speaking and able to read English

  • 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 contraceptives; Mirena IUD is acceptable
  • Cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. 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 Institute logoDana-Farber Cancer Institute
National Cancer Institute (NCI) logoNationales Krebsinstitut, USA3030 aktive klinische Studien zum Erkunden
Verantwortliche Partei
Jennifer A. Ligibel, MD, Hauptprüfer, Principal Investigator, Dana-Farber Cancer Institute
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern

Massachusetts

Dana Farber Cancer Institute, Boston, Massachusetts, 02215, United States