Pilot Study to Evaluate Targeted Physical Activity Among Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy (GI-07)
Pilot Study Evaluating the Impact of Targeted Physical Activity Among Frail Pancreatic Cancer Patients Receiving Neoadjuvant Chemotherapy
調査の概要
状態
詳細な説明
Patients with pancreatic cancer receiving neoadjuvant chemotherapy often experience functional decline, treatment interruptions, and clinical deterioration, and these risks may be amplified when frailty is present. Frailty is increasingly recognized as an important predictor of worse treatment tolerance and perioperative outcomes in pancreatic cancer populations, including higher postoperative complication risk.
The proposed targeted physical therapy program is a supervised, individualized physical activity program designed to improve strength and functional performance using low-intensity, resistance-based exercise training. In this proposal, the study will evaluate the effects of the targeted physical exercise program in frail pancreatic cancer patients receiving neoadjuvant chemotherapy by generating key data on feasibility and safety and by providing preliminary estimates of change in functional outcomes to inform the design of a future, adequately powered study.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Aslam Ejaz, MD
- 電話番号：312 996 6666
- メール：aejaz@uic.edu
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
Age ≥18 years
Diagnosis of pancreatic cancer that is potentially resectable per the treating clinical team's assessment.
Planned to receive or actively receiving neoadjuvant chemotherapy prior to surgery.
Frail or pre-frail as defined by the protocol-specified frailty assessment tool (e.g., Fried Frailty Phenotype; pre-frail = 1-2 criteria; frail => 3 criteria).
Able to provide written informed consent.
Medically appropriate to participate in supervised, symptom-limited exercise as determined by study screening and, if indicated, the treating clinician's input.
Able to complete study assessments and questionnaires in English or Spanish (using IRB-approved instruments/materials).
Exclusion Criteria:
Adults unable to consent.
Medical condition that, in the judgment of the investigator and/or treating clinician, makes exercise unsafe (e.g., unstable angina, uncontrolled arrhythmia, decompensated heart failure, uncontrolled severe pulmonary disease).
Any absolute contraindication to exercise participation/testing per institutional standards.
Severe symptoms or functional impairment that prevents safe participation despite program modification.
Inability to comply with the intervention schedule and study procedures despite reasonable scheduling accommodations.
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 |
|---|---|
|
他の：physical exercise to frail adults w pancreatic ca who are receiving neoadjuvant chemotherapy
Eligible participants may be enrolled if they plan to initiate or are actively receiving neoadjuvant chemotherapy, provided they meet all inclusion criteria and have no contraindications to supervised exercise
|
Participant will be enrolled for approximately 18-20 weeks (about 4-5 months).
This includes a baseline assessment, participation in a 36-session targeted physical exercise program
|
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 |
|---|---|---|
|
Recruitment rate
時間枠：6 months
|
Defined as the number of participants enrolled divided by the number of eligible patients approached.
|
6 months
|
|
Retention rate
時間枠：6 months
|
Defined as the proportion of enrolled participants who complete the post-intervention assessment (Session 36 assessment window).
|
6 months
|
|
Adherence rate
時間枠：6 months
|
Defined as the number of exercise sessions attended divided by 36, is summarized as a continuous measure and as the proportion of participants achieving a prespecified adherence threshold
|
6 months
|
|
Exercise-related adverse events (AEs) and serious adverse events (SAEs)
時間枠：6 months
|
Summarized by frequency, severity, and relatedness to study participation, including any events requiring modification, temporary pause, or discontinuation of the exercise program.
|
6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 1 of 3
時間枠：6 months
|
To estimate the effects of the 36-session targeted physical exercise program on functional and patient-reported outcomes in the target population. - Handgrip strength (kg), measured using a hand dynamometer (average of three trials in the dominant hand) |
6 months
|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 2 of 3
時間枠：6 months
|
To estimate the effects of the 36-session targeted physical exercise program on functional and patient-reported outcomes in the target population. - Gait speed (seconds) over a standardized 15-foot walk test |
6 months
|
|
Functional endpoints (assessed at baseline and Session 36, and at interim sessions as specified in the protocol) Part 3 of 3
時間枠：6 months
|
To estimate the effects of the 36-session targeted physical exercise program on functional and patient-reported outcomes in the target population. - Frailty score and/or frailty classification measured using the protocol-specified frailty assessment tool. |
6 months
|
|
Secondary patient-reported endpoints Part 1 of 3
時間枠：6 months
|
- Depressive symptoms assessed using the Patient Health Questionnaire-9 (PHQ-9).
|
6 months
|
|
Secondary patient-reported endpoints Part 2 of 3
時間枠：6 months
|
- Patient activation/self-management assessed using the Patient Activation Measure (PAM).
|
6 months
|
|
Secondary patient-reported endpoints Part 3 of 3
時間枠：6 months
|
- Pain severity (0-10 numeric rating scale) and pain location (descriptive).
|
6 months
|
|
Clinical endpoints obtained from routine care data Part 1 of 2
時間枠：6 months
|
- Body composition (muscle mass) assessed using standard-of-care CT imaging when available at baseline and near the end of the intervention period.
|
6 months
|
|
Clinical endpoints obtained from routine care data Part 2 of 2
時間枠：6 months
|
- Standard clinical laboratory markers obtained during routine care, including CA 19-9, albumin, creatinine, white blood cell count, and hemoglobin (baseline and post-intervention values when available).
|
6 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Optional exploratory endpoint (biopsy sub study) Part 1 of 2
時間枠：1 year and 2 year
|
Change in expression of prespecified mature microRNAs from paired optional muscle biopsy specimens collected at baseline and post-intervention among participants who consent to this component.
|
1 year and 2 year
|
|
Optional exploratory endpoint (biopsy sub study) Part 2 of 2
時間枠：1 year and 2 year
|
Recurrence-free survival at 1 and 2 years, defined as time from surgery (or enrollment, if unresected) to documented recurrence, abstracted from the EMR.
|
1 year and 2 year
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
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