Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
Endometrial Cancer and Obesity: An Exercise and Diet Intervention for Weight Loss
調査の概要
状態
詳細な説明
PRIMARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention would elicit weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.
SECONDARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength.
TERTIARY OBJECTIVES:
I. To determine if participation in a 16-week exercise and diet intervention could improve quality of life (QOL), fatigue, and depression.
II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular (CV) health.
OUTLINE:
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the dietary approaches to stop hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.
After completion of study, patients are followed up for 16 weeks.
After completion of study, patients are followed up for 16 weeks.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
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Los Angeles、California、アメリカ、90033
- USC / Norris Comprehensive Cancer Center
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-
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
説明
Inclusion Criteria:
- Clinical stage I EC
- Low grade disease positive for estrogen and progesterone receptors
- Body mass index (BMI) >= 30 kg/m^2
- No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Self ambulatory and without use of assistive walking devices
- Is not a candidate for immediate hysterectomy, following evaluation by a physician, due to desire to preserve fertility, due to degree of obesity, due to comorbidities, or due to patient refusal of hysterectomy
Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device [IUD] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)
- Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study
Exclusion Criteria:
- Patients with metastatic disease
- BMI =< 29.9 kg/m^2
- History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
- Is not self ambulatory and relies on the use of assistive walking devices
- Is a candidate for immediate hysterectomy, following evaluation by a physician
- In judgement of a physician, is not a candidate for progestin agents
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 (exercise and diet)
Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks.
Patients also undergo multi-lifestyle interventions based on the DASH diet once weekly over 1 hour for up to 16 weeks.
|
相関研究
補助研究
他の名前：
Undergo DASH diet
他の名前：
Undergo in 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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiorespiratory Fitness (CRF)
時間枠：Up to 34 weeks
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Subjects will be instructed to walk comfortably (so they are able to talk while walking) on a treadmill for 4 minutes and heart rate will be measured at the end of the test to estimate maximal oxygen uptake.
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Up to 34 weeks
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Cardiovascular (CV) health outcomes
時間枠：Up to 34 weeks
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Carotid Intima Media Thickness (cIMT) of the right common carotid artery will be measured using B-mode ultrasound.
The ultrasound scan of cIMT provides lumen diameter, intima-media thickness, and presence and extent of plaques.
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Up to 34 weeks
|
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Depression measured by Center for Epidemiologic Studies Depression scale
時間枠：Up to 34 weeks
|
Will be assessed on a continuum scale and thus our current plan is to use paired t tests.
All analysis will be performed using SPSS (v.21).
|
Up to 34 weeks
|
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Fatigue measured by the Brief Fatigue Inventory
時間枠：Up to 34 weeks
|
Will be assessed on a continuum scale and thus our current plan is to use paired t tests.
All analysis will be performed using SPSS (v.21).
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Up to 34 weeks
|
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Muscle strength
時間枠：Up to 34 weeks
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The 10-repetition maximum (10-RM) method will test maximal voluntary strength for the following exercises: chest press, seated row, knee extension, knee flexion will be used to calculate maximum strength values for the resistance exercise intervention.
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Up to 34 weeks
|
|
Percent weight loss at the completion of the intervention
時間枠：At 16 weeks
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Each of the 25 women will be classified as having achieve the 10% weight-loss or not.
Of those subjects who achieve a weight-loss of 10% or more, the proportion of patients who maintain this weight-loss will also be calculated.
The mean percent weight loss, as well as the range and quartiles will be calculated.
In addition, for those subjects who fail to achieve a 10% weight-loss, the reasons for failure will be examined (e.g.
inability to complete 16 weeks, inability to adhere to the diet, inability to adhere to the exercise schedule, etc.).
This information will guide the design (or redesign of the weight loss program as well as the follow-up studies.
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At 16 weeks
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Quality of Life (QOL)
時間枠：Up to 34 weeks
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The SF-36 short-form health survey with 36 items will be used to assess physical and mental health.
The FACT-En questionnaire will also be used.
This is a 43-item questionnaire including questions regarding the physical well-being, social/family well-being, and additional concerns on the effect of endometrial cancer on the participants.
|
Up to 34 weeks
|
協力者と研究者
捜査官
- 主任研究者：Christina Dieli-Conwright, PhD、University of Southern California
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 (見積もり)
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
その他の研究ID番号
- 5U-16-1 (その他の識別子：USC / Norris Comprehensive Cancer Center)
- P30CA014089 (米国 NIH グラント/契約)
- NCI-2016-01684 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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