- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03091842
Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer
Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
Studienübersicht
Status
Bedingungen
- Brustkrebs im Stadium I
- Krebsüberlebender
- Brustkrebs im Stadium II
- Brustkrebs im Stadium IIIA
- Brustkrebs im Stadium IIIB
- Brustkrebs im Stadium IA
- Brustkrebs im Stadium IB
- Brustkrebs im Stadium IIA
- Brustkrebs im Stadium IIB
- Brustkrebs im Stadium IIIC
- Östrogenrezeptor positiv
- Progesteronrezeptor positiv
- Brustkrebs im Stadium III
- Postmenopausal
- Zentrale Fettleibigkeit
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. To determine the effects of a 4-month circuit, interval-based aerobic and resistance exercise (CARE) intervention on obesity-associated chronic inflammation.
SECONDARY OBJECTIVES:
I. To determine the effects of a 4-month CARE intervention on sarcopenic obesity.
TERTIARY OBJECTIVES:
I. To determine the effects of a 4-month CARE intervention on breast cancer prognosis and assess whether reductions in chronic inflammation are associated with breast cancer prognosis.
OUTLINE: Patients are randomized to 1 of 3 groups.
GROUP I: Patients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
GROUP II: Patients undergo supervised traditional aerobic and resistance exercise (TARE) program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
GROUP III: Patients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks. Patients receive instructional digital video disc (DVD) and booklet of the flexibility exercises. Patients also complete a weekly activity log. After completion of the stretching program, patients may optionally undergo the CARE program as in group I.
After completion of study, patients are followed up at week 34, 8 and 12 months, and then every year for 8 years.
Studientyp
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
California
-
Los Angeles, California, Vereinigte Staaten, 90033
- USC / Norris Comprehensive Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Postmenopausal (at time of diagnosis; including artificial menopause induced by previous hysterectomy) women newly diagnosed (stage I-III) breast cancer low grade disease positive for estrogen and progesterone receptors
- Are centrally obese with the following criteria (determined by study team at eligibility screening): body mass index (BMI) > 30 kg/m^2 (calculated using height and weight; an upper limit BMI will not be set; we will rely on obtaining physicians' clearance to assess full eligibility) or body fat > 30% (estimated by bioelectrical impedance), and waist circumference > 35 inches (in)
- Have undergone a lumpectomy or mastectomy
- Have received and completed neoadjuvant or adjuvant chemotherapy and/or radiation therapy within the past 12 months
- Speak English or Spanish
- Is in breast cancer remission with no detectable disease present
- Able to initiate a supervised exercise program (free from any cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity)
- Free from history of chronic disease including uncontrolled diabetes, hypertension or thyroid disease
- Have not experienced a weight reduction >= 10% within past 6 months
- Currently participate in less than 60 minutes of structured exercise/week
- No planned reconstructive surgery with flap repair during trial and follow-up period
- May use adjuvant endocrine therapy if use will be continued for duration of study intervention
- Does not smoke (no smoking during previous 12 months)
- Willing to travel to the exercise facility at University of Southern California (USC)
Exclusion Criteria:
- Patients with metastatic disease
- Is not centrally obese
- Has not completed surgery, chemotherapy, or radiation treatment associated with their diagnosis
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Participates in more than 60 minutes of structured exercise/week
- Is planning reconstructive surgery with flap repair during trial and follow-up period
- Currently smokes
- Is unable to travel to the exercise facility at USC
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Group I (CARE program)
Patients undergo supervised CARE program over 50 minutes comprising of warm up over 5 minutes, moderate to vigorous aerobic and resistance exercises over 40 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
|
Korrelative Studien
Nebenstudien
Andere Namen:
Nebenstudien
Undergo supervised CARE program
Undergo supervised TARE program
Undergo home-based stretching program
|
Experimental: Group II (TARE program)
Patients undergo supervised TARE program over 80 minutes comprising of warm up over 5 minutes, aerobic exercise over 15 minutes, resistance exercise over 55 minutes, and cool down over 5 minutes 3 days per week for 16 weeks.
|
Korrelative Studien
Nebenstudien
Andere Namen:
Undergo supervised CARE program
Undergo supervised TARE program
Undergo home-based stretching program
|
Aktiver Komparator: Group III (home-based stretching program)
Patients undergo home-based stretching program comprising of one set of 3-4 static stretching exercises held for 30 seconds 3 days per week for 16 weeks.
Patients receive instructional DVD and booklet of the flexibility exercises.
Patients also complete a weekly activity log.
After completion of the stretching program, patients may optionally undergo the CARE program as in group I.
|
Korrelative Studien
Nebenstudien
Andere Namen:
Nebenstudien
Undergo supervised CARE program
Undergo supervised TARE program
Undergo home-based stretching program
Receive instructional DVD and booklet of the flexibility exercises
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Reduction of adipose tissue inflammation assessed by measuring M1 and M2 adipose tissue macrophages, crown-like structures, and adipose tissue secretion levels of inflammatory cytokines secreted
Zeitfenster: Up to 16 weeks
|
Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes.
Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period.
Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month).
The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes.
|
Up to 16 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Distant DFS defined as events that are either lethal (death from any cause) or a direct threat to patient survival (distant recurrence or second primary invasive cancer)
Zeitfenster: Up to 8 years
|
Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group.
Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).
|
Up to 8 years
|
Overall survival
Zeitfenster: From randomization to death from any cause, assessed up to 8 years
|
Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group.
Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).
|
From randomization to death from any cause, assessed up to 8 years
|
Recurrence-free interval defined as events directly attributable to the original breast cancer including invasive ipsilateral breast tumor recurrence; local, regional or distant recurrence; and death from breast cancer
Zeitfenster: Up to 8 years
|
A competing risks analysis will be conducted, with death modeled as a competing event, using the Fine-Gray proportional hazards model.
Analyses will be presented unadjusted, as well as adjusted for prognostic variables (age, estrogen receptor (ER)/HER2 status, tumor size, presence/number of positive nodes, and surgery (mastectomy vs. breast-sparing).
|
Up to 8 years
|
Sarcopenic obesity assessed using dual energy X-ray absorptiometry
Zeitfenster: Up to 8 months
|
Analyses for each of the continuous outcomes will involve mixed effects linear regression models, to incorporate the repeatedly measured outcomes.
Dependent variables will be the 2- and 4-month measurements of trial outcomes assessed during and at the end of the intervention period.
Independent variables will include two indicator variables for treatment group (TARE, attention control) relative to CARE, the baseline value of the outcome, and an indicator variable for measurement time (2-month/4-month).
The treatment group effect (2 degrees of freedom) will test for differences in TARE and/or attention control, relative to CARE on the 2- and 4-month outcomes.
|
Up to 8 months
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Disease free survival (DFS)
Zeitfenster: From randomization to documentation of disease recurrence or death from any cause, assessed up to 8 years
|
Kaplan-Meier estimates and log-rank tests will be used to estimate and initially test cumulative survival probabilities by treatment group.
Cox proportional hazards models will be used to compare treatment groups (with 2 indicator variables for treatment group).
Ancillary analyses will assess associations of inflammation measures with DFS.
Results will be presented as hazard ratios, with 95% confidence intervals.
Unadjusted and adjusted survival curves will be presented by treatment group.
|
From randomization to documentation of disease recurrence or death from any cause, assessed up to 8 years
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Christina Dieli-Conwright, PhD, University of Southern California
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Voraussichtlich)
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 1B-16-11 (Andere Kennung: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (US NIH Stipendium/Vertrag)
- NCI-2017-00070 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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