Exercise Intervention in Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer
21 października 2019 zaktualizowane przez: University of Southern California
Taking AIM at Breast Cancer: Targeting Adiposity and Inflammation With Movement to Improve Prognosis in Breast Cancer Survivors
This randomized phase II trial studies how well exercise intervention works in targeting adiposity and inflammation with movement to improve prognosis in stage I-III breast cancer survivors.
Different types of exercise may reduce inflammation in fat tissue and minimize the risk of cancer recurrence related to being overweight or obese.
Przegląd badań
Status
Wycofane
Warunki
- Rak piersi I stopnia
- Zwycięzca nad Rakiem
- Rak piersi II stopnia
- Rak piersi w stadium IIIA
- Rak piersi w stadium IIIB
- Rak piersi w stadium IA
- Rak piersi w stadium IB
- Rak piersi w stadium IIA
- Rak piersi w stadium IIB
- Rak piersi w stadium IIIC
- Pozytywny receptor estrogenowy
- Pozytywny receptor progesteronu
- Rak piersi III stopnia
- Po menopauzie
- Centralna otyłość
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
California
-
Los Angeles, California, Stany Zjednoczone, 90033
- USC / Norris Comprehensive Cancer Center
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
Badania korelacyjne
Badania pomocnicze
Inne nazwy:
Badania pomocnicze
Undergo supervised CARE program
Undergo supervised TARE program
Undergo home-based stretching program
|
|
Eksperymentalny: 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.
|
Badania korelacyjne
Badania pomocnicze
Inne nazwy:
Undergo supervised CARE program
Undergo supervised TARE program
Undergo home-based stretching program
|
|
Aktywny 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.
|
Badania korelacyjne
Badania pomocnicze
Inne nazwy:
Badania pomocnicze
Undergo supervised CARE program
Undergo supervised TARE program
Undergo home-based stretching program
Receive instructional DVD and booklet of the flexibility exercises
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Disease free survival (DFS)
Ramy czasowe: 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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Główny śledczy: Christina Dieli-Conwright, PhD, University of Southern California
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
29 lipca 2019
Zakończenie podstawowe (Oczekiwany)
29 lipca 2024
Ukończenie studiów (Oczekiwany)
29 lipca 2025
Daty rejestracji na studia
Pierwszy przesłany
21 marca 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
21 marca 2017
Pierwszy wysłany (Rzeczywisty)
27 marca 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
24 października 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
21 października 2019
Ostatnia weryfikacja
1 października 2019
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 1B-16-11 (Inny identyfikator: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (Grant/umowa NIH USA)
- NCI-2017-00070 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .