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Eating, Activity, and Stress Education (EASE)

2019年4月16日 更新者: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.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

介入

入学 (実際)

58

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • South Carolina
      • Columbia、South Carolina、アメリカ、29203
        • Palmetto Richland Memorial Hospital
      • Columbia、South Carolina、アメリカ、29201
        • Palmetto Baptist Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

説明

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)

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

介入なし:Control group
Usual care (watchful waiting).

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in prostate-specific antigen from baseline
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:James R Hebert, Sc.D.、University of South Carolina

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2003年1月1日

一次修了 (実際)

2007年7月1日

研究の完了 (実際)

2007年7月1日

試験登録日

最初に提出

2011年9月7日

QC基準を満たした最初の提出物

2011年9月13日

最初の投稿 (見積もり)

2011年9月14日

学習記録の更新

投稿された最後の更新 (実際)

2019年4月18日

QC基準を満たした最後の更新が送信されました

2019年4月16日

最終確認日

2019年4月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • DAMD17-03-1-0139

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

前立腺がんの臨床試験

  • Jonsson Comprehensive Cancer Center
    National Cancer Institute (NCI); Highlight Therapeutics
    積極的、募集していない
    平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件
    アメリカ

Lifestyle counselingの臨床試験

3
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