ステージ I ～ III の乳癌の過体重/肥満患者の減量のための膵臓栄養プログラム
PANCREATIC NUTRITIONAL PROGRAM (PNP): 過体重/肥満乳がんサバイバーの新しい減量プログラム
This pilot clinical trial studies a pancreatic nutritional program for helping patients with stage I-III breast cancer who are overweight or obese lose weight. When patients have a high level of sugar in their blood, due to eating sugary foods and/or a sedentary lifestyle, the pancreas needs to work harder to digest the sugar. This can cause weight gain, obesity, and other illnesses. Breast cancer patients who are overweight and obese are more likely to have their breast cancer return. The pancreatic nutritional program is a diet and lifestyle intervention that helps protect the pancreas by keeping blood sugar levels low, and may help patients achieve sustained weight loss, improved health, better quality of life, and possibly a better outcome to their treatment.
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To estimate the change in body weight at 6 months post-intervention relative to baseline.
SECONDARY OBJECTIVES:
I. To examine changes in: body composition; body chemistry; physical fitness; inflammatory markers; deoxyribonucleic acid (DNA) repair capacity; and quality of life per the Functional Assessment of Cancer Therapy - Breast (FACT-B)+4, version 4 questionnaire at 6 months post-intervention relative to baseline.
II. To describe adverse events possibly related to wearing the glucometer sensor or following the pancreatic nutritional program (PNP) diet.
III. To document compliance with the various components of the PNP (wearing the glucometer sensor; recording body weight; completing journal entries; completing meal cards; attending weekly counseling sessions with diet instructor).
OUTLINE:
Patients participate in the PNP intervention, which begins with a baseline meeting with a diet and lifestyle instructor to discuss baseline testing results, begin an educational plan, determine an individualized eating plan, and print out food choices. Patients also undergo automated glucometry every 15 minutes, review their individual food choices and blood glucose levels 90 minutes after eating, keep a daily nutrition and lifestyle journal log, fill out a daily meal discovery card log, and attend weekly meetings with a diet and lifestyle instructor for 12 weeks.
After completion of study, patients are followed up within 1 week and then at 6 months.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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Duarte、California、アメリカ、91010
- City of Hope Medical Center
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients with early-stage breast cancer (stage I-III)
- Patients who have or have not undergone chemotherapy are both eligible; if the patient has undergone chemotherapy she must have completed adjuvant chemotherapy for >= 3 months and =< 5 years prior to study enrollment
- Postmenopausal women defined by either: natural menopause with at least one year since last menses, or chemotherapy-induced menopause with at least one year since last menses and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
- Body mass index (BMI) of 25-33 kg/m^2
- Patients must be willing to adhere to the PNP intervention and the entire 6-month study
- All patients must have the ability and the willingness to sign a written informed consent
Exclusion Criteria:
- Patients who are diabetic
- Patients whose BMI falls outside the eligible range (< 25 kg/m^2 or > 33 kg/m^2)
- Patients with stage IV breast cancer
- Patients with Rheumatoid Arthritis and other inflammatory diseases that would impact correlative studies
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
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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：Supportive care (PNP)
Patients participate in the PNP intervention, which begins with a baseline meeting with a diet and lifestyle instructor to discuss baseline testing results, begin an educational plan, determine an individualized eating plan, and print out food choices. Patients also undergo automated glucometry every 15 minutes, review their individual food choices and blood glucose levels 90 minutes after eating, keep a daily nutrition and lifestyle journal log, fill out a daily meal discovery card log, and attend weekly meetings with a diet and lifestyle instructor for 12 weeks. |
Correlative studies Ancillary studies
他の名前：
Participate in the PNP
他の名前：
Participate in the PNP
他の名前：
|
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 body weight
時間枠：Baseline to 6 months
|
Tested using the paired t-test, alpha = 0.05. |
Baseline to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
QOLスコアの変化（FACT-B+4）
時間枠：ベースラインから 6 か月
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ベースラインから 6 か月
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コンプライアンス指標 (グルコメーターセンサーを使用しなかった日、体重を記録しなかった日、日誌を作成しなかった日、食事カードを作成しなかった日、毎週のカウンセリングセッションを欠席した日)
時間枠：12週間
|
12週間
|
|
|
PNPダイエット後のグルコメーターセンサーの装着に関連する可能性がある、または確実に関連すると報告された有害事象の発生率
時間枠：6ヶ月まで
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6ヶ月まで
|
|
|
Change in body chemistry (lipid panel; comprehensive metabolic panel; complete blood count; fasting blood glucose; insulin resistance)
時間枠：Baseline to up to 6 months
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Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to up to 6 months
|
|
Change in body composition (BMI)
時間枠：Baseline to up to 6 months
|
Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to up to 6 months
|
|
Change in physical fitness (measured using a handgrip dynamometer)
時間枠：Baseline to 6 months
|
Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to 6 months
|
|
Change in serum inflammatory markers (C-reactive protein; cytokines)
時間枠：Baseline to 6 months
|
Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to 6 months
|
|
DNA repair capacity (comet assay's mean olive tail moment; number of gamma-H2A histone family, member X foci)
時間枠：Baseline to 6 months
|
Tested using the paired t-test, alpha = 0.05. P values will not be adjusted for multiple hypothesis testing. |
Baseline to 6 months
|
協力者と研究者
捜査官
- 主任研究者：Joanne Mortimer、City of Hope Medical Center
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (推定)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 14253
- 14253 (その他の識別子：City of Hope Medical Center)
- NCI-2015-00654 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
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。