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Eating, Activity, and Stress Education (EASE)

16. april 2019 oppdatert av: James hebert, University of South Carolina

A Diet, Physical Activity, and Meditation Intervention in Men With Rising Prostate-specific Antigen

The purpose of this study is to determine whether a vegetable-based diet, physical activity program, and stress reduction training will reduce or maintain PSA levels, an indicator of prostate cancer progression, in men who have had their prostate gland removed following a prostate cancer diagnosis.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Following surgery or radiation of a primary early-stage prostate cancer (PrCA), one in three patients will experience an elevation in serum prostate antigen (PSA) within 10 years. For men whose primary treatment was prostatectomy, a PSA rise virtually always signals the spread of PrCA. After such evidence of recurrence, the "standard" treatment is medical or surgical castration. Castration results in reducing the PSA about 85% of the time, but it makes no difference whether such treatment occurs before or after the appearance of clinical symptoms of recurrence. This time interval between the first rise in PSA and symptom appearance may be many years. The most salient fact, however, is that castration does not prolong men's lives and it is not certain whether it even meaningfully delays symptom appearance in men who receive the treatment at the first sign of biochemical recurrence. Castration also has significant side effects including osteoporosis (bone loss), decreased muscle mass, impotence, and urinary incontinence. Because PrCA is usually a disease of older men, many will succumb to other diseases before they ever develop a symptom related to metastatic PrCA. For this large fraction of men, a treatment with deleterious affects on quality of life and no clear overall survival benefit may not be a good choice. The protocol the investigators propose will be performed instead of medical or surgical castration, which is not medically indicated at this point in the course of PrCA. Castration can and will be offered to these men at the first clinical symptom or sign of metastatic cancer, at which time those men will come off this study. It also is important to note that if the intervention results in reductions in PSA then the investigators will offer it to all men who had been randomized to the control condition initially. The investigators will conduct this randomized study in 60 asymptomatic men who have undergone radical prostatectomy (removal of the prostate gland) as their primary therapy of biopsy-confirmed adenocarcinoma of the prostate and subsequently have been found to have rising PSA levels, indicating an early recurrence of the cancer. Half (30) of these men will be randomized to usual care (watchful waiting) and the other half to an intervention consisting of a vegetable-based diet, program of physical activity timed to the natural rhythm of the day (i.e., circadian, or "around the day" - basically to timing of their exercise to improve their sleep cycles), and mindfulness-based stress reduction (consisting of meditation and other stress-reducing techniques). The intervention will continue for three months, followed by monthly booster sessions for 9 months. Data will be collected on compliance with the intervention and other factors that could modify the intervention or confuse our interpretation of its effect. The overall goal of the study will be to see the effect of making these behavioral and attitudinal changes on PSA levels, an indicator of disease progression in these men. The therapies the investigators will study are completely non-toxic and behavioral in nature.

Studietype

Intervensjonell

Registrering (Faktiske)

58

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • South Carolina
      • Columbia, South Carolina, Forente stater, 29203
        • Palmetto Richland Memorial Hospital
      • Columbia, South Carolina, Forente stater, 29201
        • Palmetto Baptist Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Beskrivelse

Inclusion Criteria:

  • have a histologically confirmed diagnosis of adenocarcinoma of the prostate
  • have been treated by radical prostatectomy or radiation therapy
  • have had no malignancy in the past 5 years (except the primary prostate cancer for which initial treatment was sought and non malignant melanoma of the skin)
  • not be taking thyroid medication, antibiotics, diuretics or steroids
  • be able to read at a sixth grade level
  • speak English as their first language
  • be of sound mind, memory, and understanding as evaluated by recruitment staff
  • have experienced a rise in serum PSA concentration after achieving a post surgery nadir, after achieving a post radiation nadir, or having had both a radical prostatectomy and subsequent radiotherapy

Exclusion Criteria:

  • has received high dose radiotherapy or brachytherapy in place of surgery as a primary treatment
  • has received post-operative hormone therapy for prostate cancer
  • received treatment of prostate cancer with an LH-RH analog
  • has a diagnosis of cardiovascular, pulmonary, or metabolic disease or major symptoms of these diseases, including pain or discomfort in the chest, neck, jaw, arms or other areas that may be due to ischemia; shortness of breath or unusual fatigue at rest or with mild exertion; dizziness; dyspnea while sleeping; ankle edema or intermittent claudication; palpitations, tachycardia, or a known heart murmur
  • has experienced a weight loss in excess of five pounds in the previous 3 months
  • regularly consumes more than two alcoholic drinks per day
  • plans on taking hormone supplements such as melatonin, or fish oil or other; supplements rich in omega-3 fatty acids
  • has been diagnosed with Crohn's disease or has active ulcerative colitis
  • has been diagnosed with Post Traumatic Stress Disorder (PTSD)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Lifestyle counseling

Diet component: focus on increasing intake of whole grains, soybeans, soybean products, other beans, and vegetables.

Physical Activity: encourage completion of morning exercise sessions. Mindfulness Stress Reduction: training in mindfulness meditation, including dealing with intensive physical symptoms and difficult emotional situations.

Diet component: focus on increasing intake of whole grains, soybeans, soybean products, other beans, and vegetables.

Physical Activity: encourage completion of morning exercise sessions. Mindfulness Stress Reduction: training in mindfulness meditation, including dealing with intensive physical symptoms and difficult emotional situations.

Ingen inngripen: Control group
Usual care (watchful waiting).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in prostate-specific antigen from baseline
Tidsramme: baseline, 3 months, 6 months
PSA is measured at baseline, 3 months and 6 months. Change in PSA is the primary outcome measure.
baseline, 3 months, 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: James R Hebert, Sc.D., University of South Carolina

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2003

Primær fullføring (Faktiske)

1. juli 2007

Studiet fullført (Faktiske)

1. juli 2007

Datoer for studieregistrering

Først innsendt

7. september 2011

Først innsendt som oppfylte QC-kriteriene

13. september 2011

Først lagt ut (Anslag)

14. september 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • DAMD17-03-1-0139

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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