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Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer

15. december 2020 opdateret af: 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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90033
        • USC / Norris Comprehensive Cancer Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: Livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • Livskvalitetsvurdering
Kosttilskud: Dietary Intervention
Undergo DASH diet
Andre navne:
  • Kostændringer
  • intervention, diæt
  • Ernæringsintervention
  • Ernæringsinterventioner
  • Ernæringsmæssige interventioner
Adfærdsmæssigt: Exercise Intervention
Undergo in aerobic exercise

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cardiorespiratory Fitness (CRF)
Tidsramme: 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.
Up to 34 weeks
Cardiovascular (CV) health outcomes
Tidsramme: 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.
Up to 34 weeks
Depression measured by Center for Epidemiologic Studies Depression scale
Tidsramme: 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).
Up to 34 weeks
Fatigue measured by the Brief Fatigue Inventory
Tidsramme: 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).
Up to 34 weeks
Muscle strength
Tidsramme: Up to 34 weeks
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.
Up to 34 weeks
Percent weight loss at the completion of the intervention
Tidsramme: At 16 weeks
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.
At 16 weeks
Quality of Life (QOL)
Tidsramme: Up to 34 weeks
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.
Up to 34 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Southern California

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Christina Dieli-Conwright, PhD, University of Southern California

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. september 2017

Primær færdiggørelse (Faktiske)

31. juli 2019

Studieafslutning (Faktiske)

31. juli 2019

Datoer for studieregistrering

Først indsendt

1. februar 2017

Først indsendt, der opfyldte QC-kriterier

1. februar 2017

Først opslået (Skøn)

3. februar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. december 2020

Sidst verificeret

1. december 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 5U-16-1 (Anden identifikator: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH-bevilling/kontrakt)
  • NCI-2016-01684 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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