Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
15 december 2020 bijgewerkt door: University of Southern California
Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer.
Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.
Studie Overzicht
Toestand
Ingetrokken
Conditie
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention would elicit weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.
SECONDARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength.
TERTIARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention could improve quality of life (QOL), fatigue, and depression.
II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular (CV) health.
OUTLINE:
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the dietary approaches to stop hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.
After completion of study, patients are followed up for 16 weeks.
After completion of study, patients are followed up for 16 weeks.
Studietype
Ingrijpend
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90033
- USC / Norris Comprehensive Cancer Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
19 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria:
- Clinical stage I EC
- Low grade disease positive for estrogen and progesterone receptors
- Body mass index (BMI) >= 30 kg/m^2
- No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Self ambulatory and without use of assistive walking devices
- Is not a candidate for immediate hysterectomy, following evaluation by a physician, due to desire to preserve fertility, due to degree of obesity, due to comorbidities, or due to patient refusal of hysterectomy
Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device [IUD] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)
- Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study
Exclusion Criteria:
- Patients with metastatic disease
- BMI =< 29.9 kg/m^2
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Is not self ambulatory and relies on the use of assistive walking devices
- Is a candidate for immediate hysterectomy, following evaluation by a physician
- In judgement of a physician, is not a candidate for progestin agents
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Supportive Care (exercise and diet)
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks.
Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks.
|
Correlatieve studies
Nevenstudies
Andere namen:
Undergo DASH diet
Andere namen:
Undergo in aerobic exercise
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Cardiorespiratory Fitness (CRF)
Tijdsspanne: Up to 34 weeks
|
Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.
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Up to 34 weeks
|
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Cardiovascular (CV) health outcomes
Tijdsspanne: Up to 34 weeks
|
Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound.
The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques.
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Up to 34 weeks
|
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Depression measured by Center for Epidemiologic Studies Depression scale
Tijdsspanne: Up to 34 weeks
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Will be assessed on a continuum scale and thus our current plan is to use paired t tests.
All analysis will be performed using SPSS (v.21).
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Up to 34 weeks
|
|
Fatigue measured by the Brief Fatigue Inventory
Tijdsspanne: Up to 34 weeks
|
Will be assessed on a continuum scale and thus our current plan is to use paired t tests.
All analysis will be performed using SPSS (v.21).
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Up to 34 weeks
|
|
Muscle strength
Tijdsspanne: Up to 34 weeks
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The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.
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Up to 34 weeks
|
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Percent weight loss at the completion of the intervention
Tijdsspanne: At 16 weeks
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Each of the 25 women will be classified as having achieve the 10% weight-loss or not.
Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated.
The mean percent weight loss, as well as the range and quartiles will be calculated.
In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g.
inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.).
This information will guide the design (or redesign of the weight loss program as well as the follow-up studies.
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At 16 weeks
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Quality of Life (QOL)
Tijdsspanne: Up to 34 weeks
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The SF-36 short-form health survey with 36 items will be used to assess physical and mental health.
The FACT-En questionnaire will also be used.
This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants.
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Up to 34 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Christina Dieli-Conwright, PhD, University of Southern California
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
8 september 2017
Primaire voltooiing (Werkelijk)
31 juli 2019
Studie voltooiing (Werkelijk)
31 juli 2019
Studieregistratiedata
Eerst ingediend
1 februari 2017
Eerst ingediend dat voldeed aan de QC-criteria
1 februari 2017
Eerst geplaatst (Schatting)
3 februari 2017
Updates van studierecords
Laatste update geplaatst (Werkelijk)
17 december 2020
Laatste update ingediend die voldeed aan QC-criteria
15 december 2020
Laatst geverifieerd
1 december 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 5U-16-1 (Andere identificatie: USC / Norris Comprehensive Cancer Center)
- P30CA014089 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2016-01684 (Register-ID: CTRP (Clinical Trial Reporting Program))
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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