A Longitudinal Investigation of Cognitive Function in Colorectal Cancer Patients
Cognitive Function and Fatigue in Cancer Patients After Chemotherapy: A Longitudinal Controlled Study in Patients With Colorectal Cancer
This is a prospective, longitudinal, controlled study of cognitive function and fatigue in patients with apparently localized CRC treated with adjuvant or neoadjuvant chemotherapy. In addition to following each patient over time (i.e. acting as their own control), a separate control group will consist of patients with early stage CRC (Stage A or B) who have had surgical resection of their tumour, but who do not require adjuvant chemotherapy, or patients with stage C CRC who have declined chemotherapy.
Also included is a smaller sub-study of patients with limited metastatic CRC who are treated with more toxic chemotherapy
To compare changes in cognitive function, as compared to baseline assessment, of patients with CRC who do, or do not, receive 5FU-based chemotherapy. The primary measures of cognitive function are the High Sensitivity Cognitive Screen (HSCS) & Coghealth™.
調査の概要
状態
条件
研究の種類
入学 (実際)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Aged 18-70 years old
- Performance Status (PS) of 0-1 on the ECOG Performance Scale
- Life expectancy of at least 12 months
- Full recovery from any post operative sequelae
- Adequate hepatic function as documented by a serum bilirubin < 18umol/L, and LFTs within 1.5X normal range
- Patients with histologically confirmed, stage B or C colorectal cancer (CRC), who have undergone surgical resection and are about to commence chemotherapy.
- Patients due to receive neoadjuvant chemotherapy prior to surgery are also eligible.
Exclusion Criteria:
- Any major pre-existing psychiatric history or dementia, alcohol abuse, or currently using a psychotropic medication that might lead to cognitive problems, other than short acting benzodiazepines for nausea or sleep
- Any evidence of metastatic disease. If there is clinical suspicion of CNS involvement patients must have brain imaging (MRI or CT scan) prior to recruitment.
- Ongoing sepsis or uncontrolled infection, including HIV infection
- Pre-existing neurological condition likely to interfere with ability to perform cognitive testing
- Any other severe co-morbidity which, in the judgement of the investigator, would make the patient inappropriate for entry into this study
- Active cancer within the last 5 years other than squamous or basal cell carcinoma of the skin or cervical cancer in situ (except for CRC)
- Previous history of chemotherapy
- Minimal English skills such that subjects would be unable to follow simple, written English instructions and to read questionnaires of a grade 8 standard with the help of a research assistant.
研究計画
研究はどのように設計されていますか?
デザインの詳細
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 |
---|---|---|
Cognitive Function
時間枠:2 years
|
To compare changes in cognitive function, as compared to baseline assessment, of patients with CRC who do, or do not, receive 5FU-based chemotherapy.
The primary measures of cognitive function are the High Sensitivity Cognitive Screen (HSCS) & Coghealth™.
|
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Potential mechanisms leading to fatigue and/or cognitive decline
時間枠:2 Years
|
To evaluate potential mechanisms leading to fatigue and/or cognitive decline.
To measure hemoglobin, serum levels of sex hormones (LH, FSH, estradiol (in women), testosterone (in men)), selected cytokines (TNF-α, IL-1 & IL-6), homocysteine, markers of blood coagulation (thrombin-anti-thrombin (TAT), prothrombin fragment 1 & 2, and d-dimers), and the apolipoprotein E genotype
|
2 Years
|
協力者と研究者
捜査官
- 主任研究者:Ian F Tannock, MD, PhD, DSc、UHN/PMH
研究記録日
主要日程の研究
研究開始
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
大腸がんの臨床試験
-
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