The Activity Intervention for Chemobrain (TACTIC)
2017年3月30日 更新者:Vanderbilt University Medical Center
Exercise Intervention for Chemotherapy-Related Cognitive Dysfunction
Cognitive dysfunction following chemotherapy is an adverse treatment effect that impacts the quality of life for many cancer survivors receiving this adjuvant therapy.
A strong body of evidence now indicates that that the initiation of a regular exercise program, at levels that are readily achievable by most adults (3-5 d/wk, 30-45 min/session), can improve cognitive function.
Importantly, the domains of cognitive function that are enhanced by exercise participation are the same domains that are negatively affected by chemotherapy.
Accordingly, we propose a 2 year research program that seeks to develop and test a safe, simple, and effective exercise intervention to optimize cognitive function following chemotherapy.
To begin this research, we will: 1) conduct a randomized exercise intervention trial among cancer survivors that report persistent cognitive problems following chemotherapy (n=60), 2) explore possible mediators and moderators of the intervention on cognition in order to begin to understand how the intervention may work and for whom it may be most effective, and 3), conduct a cross-sectional study comparing cancer survivors enrolled in the trial (n=60) and matched controls (n=40) to evaluate the cognitive status among survivors in the intervention.
We hypothesize that six-months of regular exercise will enhance cognitive function among cancer survivors, and that cancer survivors reporting cognitive dysfunction will have lower objectively measured cognitive performance than adults who have not received chemotherapy.
To our knowledge this study would be the first to examine the influence of regular exercise participation on cognitive function among cancer survivors that experienced cognitive difficulties following chemotherapy.
調査の概要
詳細な説明
A substantial number of cancer survivors who receive chemotherapy report mild to moderate cognitive impairment following treatment.
These impairments have been reported across a range of cancer types and chemotherapy agents.
Adjuvant treatment has been reported to affect multiple cognitive domains, but three domains appear to be most strongly affected (i.e., executive functioning, declarative memory, motor function).
Exercise participation, at levels that are readily achievable by most adults (3-5 d/wk, 30-45 min/d), preserves and enhances cognitive function.
Importantly, domains that are enhanced by exercise overlap substantially with the domains adversely affected by chemotherapy.
Accordingly, we propose a 2 year research program that seeks to develop and test a safe, simple, and effective exercise intervention to optimize cognitive function following chemotherapy.
To begin this research, we will: 1) conduct a randomized exercise intervention trial among cancer survivors that report persistent cognitive problems following chemotherapy (exercise, n=30 vs. standard of care, n=30); 2) explore possible mediators and moderators of the intervention effect on cognition; and 3), conduct a cross-sectional study comparing cancer survivors enrolled in the trial (n=60) and matched controls (n=40) to evaluate the cognitive status among survivors in the intervention.
We will employ a proven home-based exercise intervention and state of the art cognitive testing of relevant cognitive domains (e.g., Randt Memory Test, Trail Making B, Stroop task, T ask switching, Response compatibility) that we have used in preliminary studies.
We hypothesize that six-months of regular exercise will enhance cognitive function among cancer survivors, and that cancer survivors reporting cognitive dysfunction will have lower objectively measured cognitive performance than adults who have not received chemotherapy.
To our knowledge this study would be the first to examine the influence of regular exercise participation on cognitive function among cancer survivors that experienced cognitive difficulties following chemotherapy.
Completion of this project will provide our research team with the necessary experience and intervention effectiveness information that will be used to conduct future more definitive trials.
研究の種類
介入
入学 (実際)
64
段階
- フェーズ2
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
-
-
Tennessee
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Nashville、Tennessee、アメリカ、37203
- Vanderbilt University 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
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Non-metastatic cancer and received at least 4 cycles of chemotherapy, and report the onset of persistent cognitive difficulties following treatment Age 18+ yrs
Exclusion Criteria:
- Have no prior diagnosis of cancer of the central nervous system,
- Not have engaged in regular exercise in the past year (i.e., 5+ days/wk, 20+ min/d, 3+ months),
- No cardiovascular disease or orthopedic problems that could be worsened by exercise as reported on the Physical Activity Readiness Questionnaire
- No major systemic diseases (e.g., liver, kidney or adrenal diseases).
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:支持療法
- 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 |
|---|---|
|
アクティブコンパレータ:2
いつものお手入れ
|
6-months of behavioral strategies to aid memory/cognition
|
|
実験的:1
エクササイズ
|
6-months of regular aerobic exercise
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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 |
時間枠 |
|---|---|
|
Objective measures of cognitive function (a test battery)
時間枠:6-months
|
6-months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Exploratory analyses of psychological status, cardiorespiratory fitness, and inflammatory markers in blood.
時間枠:6-months
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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:Charles E. Matthews, PhD、Vanderbilt University Medical Center
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
2006年2月1日
一次修了 (実際)
2008年1月1日
研究の完了 (実際)
2008年1月1日
試験登録日
最初に提出
2007年7月2日
QC基準を満たした最初の提出物
2007年7月2日
最初の投稿 (見積もり)
2007年7月3日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月4日
QC基準を満たした最後の更新が送信されました
2017年3月30日
最終確認日
2017年3月1日
詳しくは
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。