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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 uppdaterad av: 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.

Studieöversikt

Status

Indragen

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • California
      • Duarte, California, Förenta staterna, 91010
        • City of Hope Medical Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Övrig: Laboratoriebiomarköranalys
Korrelativa studier
Övrig: Livskvalitetsbedömning
Sidostudier
Andra namn:
  • Livskvalitetsbedömning
Övrig: Enkätadministration
Sidostudier
Beteende: Exercise Intervention
Undergo supervised 1-on-1 exercise sessions

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Adherence to the data collection and exercise trial protocol, defined as the number of sessions attended, questionnaires completed, and blood samples completed
Tidsram: 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
Tidsram: 12 months
12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in body composition
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to 12 months
Up to 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

City of Hope Medical Center

Samarbetspartners

National Cancer Institute (NCI)

Utredare

  • Huvudutredare: Jessica Clague DeHart, PhD, City of Hope Medical Center

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

2 september 2016

Primärt slutförande (Förväntat)

1 december 2018

Avslutad studie (Förväntat)

1 december 2018

Studieregistreringsdatum

Först inskickad

2 augusti 2016

Först inskickad som uppfyllde QC-kriterierna

22 augusti 2016

Första postat (Uppskatta)

25 augusti 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juni 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juni 2018

Senast verifierad

1 juni 2018

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 15388 (Annan identifierare: City of Hope Medical Center)
  • NCI-2016-01183 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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