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An Exercise Intervention Trial to Reduce Symptoms & Improve Clinical Outcomes of Platinum-Based Treatment in Ovarian Cancer Patients

13. juni 2018 opdateret af: City of Hope Medical Center
This clinical trial studies how well an exercise intervention works in reducing symptoms and improving clinical outcomes in patients with ovarian cancer undergoing platinum-based chemotherapy. Exercise may "train" the body to repair deoxyribonucleic acid (DNA) damage more efficiently, which may reduce symptoms related to platinum-based chemotherapy, improve quality of life, increase survival, and decrease recurrence rates in patients with ovarian cancer.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. To assess the feasibility of recruiting and enrolling newly diagnosed epithelial ovarian cancer patients who have undergone debulking surgery and will be starting platinum-based chemotherapy, to an exercise trial.

II. To evaluate adherence to the data collection and exercise trial protocol. It is necessary to determine the feasibility of collecting tablet-based questionnaire data and blood samples at multiple time points in one visit. It is also critical to determine whether the exercise intervention is feasible in this patient population.

SECONDARY OBJECTIVES:

I. To examine changes in DNA repair function before and after a single exercise session.

II. To examine changes in DNA repair function, body composition, quality of life, symptoms and patient satisfaction with care over the treatment time course.

III. To examine the effect of the exercise intervention on these measurements.

IV. To follow the patients an additional 12-months for clinical outcomes defined as death, cancer recurrence, or new primary cancer.

OUTLINE: Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.

After completion of study, patients are followed up for 12 months.

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
      • Duarte, California, Forenede Stater, 91010
        • City of Hope Medical 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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Women who have been newly diagnosed with a first primary, epithelial ovarian cancer, have undergone surgical debulking and who will be treatment according to the Armstrong method
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately.
  • Newly diagnosed, primary, epithelial ovarian cancer
  • Have undergone surgical debulking
  • Will be treated according to the Armstrong method
  • Read and understand English
  • All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

  • Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

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: Arm I (exercise intervention)
Patients undergo supervised 1-on-1 exercise sessions for 60 minutes on day 1.Treatment repeats every 3 weeks for up to 18 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive a home-based exercise prescription including instructions for keeping patients' heart rate within 50-80% maximum.
Andet: Laboratoriebiomarkøranalyse
Korrelative undersøgelser
Andet: Livskvalitetsvurdering
Hjælpestudier
Andre navne:
  • Livskvalitetsvurdering
Andet: Spørgeskemaadministration
Hjælpestudier
Adfærdsmæssigt: Exercise Intervention
Undergo supervised 1-on-1 exercise sessions

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Adherence to the data collection and exercise trial protocol, defined as the number of sessions attended, questionnaires completed, and blood samples completed
Tidsramme: 18 weeks
18 weeks
Feasibility of recruiting and enrolling patients to an exercise trial, defined as the number of people contacted, eligible consented and enrolled
Tidsramme: 12 months
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in body composition
Tidsramme: Baseline to 18 weeks
Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.
Baseline to 18 weeks
Change in DNA repair function, assessed by host reactivation assays
Tidsramme: Before single exercise session to after single exercise session, assessed up to 12 months
Will be analyzed using paired t-tests
Before single exercise session to after single exercise session, assessed up to 12 months
Change in DNA repair function, assessed by host reactivation assays
Tidsramme: Baseline to 18 weeks
Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.
Baseline to 18 weeks
Change in quality of life, assessed by questionnaires
Tidsramme: Baseline to 18 weeks
Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.
Baseline to 18 weeks
Change in symptoms, assessed by National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 version 2
Tidsramme: Baseline to 18 weeks
Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.
Baseline to 18 weeks
Change in treatment satisfaction, assessed by Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-General
Tidsramme: Baseline to 18 weeks
Will be analyzed using paired t-tests. Data from women in course 1 will be compared to data in women in course 6.
Baseline to 18 weeks
Clinical outcome follow-up defined as death, cancer recurrence, or new primary cancer
Tidsramme: Up to 12 months
Up to 12 months

Samarbejdspartnere og efterforskere

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

Sponsor

City of Hope Medical Center

Samarbejdspartnere

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Jessica Clague DeHart, PhD, City of Hope Medical center

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

2. september 2016

Primær færdiggørelse (Forventet)

1. december 2018

Studieafslutning (Forventet)

1. december 2018

Datoer for studieregistrering

Først indsendt

2. august 2016

Først indsendt, der opfyldte QC-kriterier

22. august 2016

Først opslået (Skøn)

25. august 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 15388 (Anden identifikator: City of Hope Medical Center)
  • NCI-2016-01183 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Ovariekarcinom

Kliniske forsøg med Laboratoriebiomarkøranalyse

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