Exercise During and After Neoadjuvant Rectal Cancer Treatment (EXERT)
2022년 5월 24일 업데이트: University of Alberta
A Phase II Randomized Controlled Trial of Aerobic Exercise in Rectal Cancer Patients During and After Neoadjuvant Chemoradiotherapy
This study is designed to investigate if aerobic exercise during and after neoadjuvant chemoradiotherapy (NACRT) can improve outcomes for rectal cancer patients.
연구 개요
상세 설명
The EXERT trial is a single-center, prospective, two-armed, phase II randomized controlled trial designed to test the preliminary efficacy of exercise training in this clinical setting and to further evaluate its feasibility and safety.
Participants will be 60 rectal cancer patients scheduled to receive long-course NACRT followed by total mesorectal excision.
Participants will be randomly assigned to exercise training or usual care.
Participants in the exercise training group will be asked to complete three supervised, high-intensity interval training sessions/week during NACRT and ≥ 150 min/week of unsupervised, moderate-to-vigorous-intensity, continuous exercise training after NACRT prior to surgery.
Participants in the usual care group will be asked not to increase their exercise from baseline.
Assessments will be completed pre NACRT, post NACRT, and pre surgery.
The primary endpoint will be cardiorespiratory fitness (VO2 peak) at the post-NACRT time point assessed by a graded exercise test.
Secondary endpoints will include functional fitness, quality of life, and symptom management.
Exploratory clinical endpoints will include treatment toxicities, treatment completion, treatment response, and surgical complications.
연구 유형
중재적
등록 (실제)
36
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Alberta
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Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- All patients scheduled to receive long-course (5-6 weeks) of NACRT followed by total mesorectal excision
Exclusion Criteria:
- Unable to consent
- Unable to perform aerobic exercise
- Intention to engage in a structured exercise program during NACRT and/or after NACRT and prior to surgery
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 운동
유산소 운동
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Supervised high-intensity interval training (HIIT) during NACRT followed by unsupervised moderate-to-vigorous intensity continuous exercise training after the completion of NACRT and before surgery
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간섭 없음: Usual Care
Standard medical care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Cardiorespiratory fitness
기간: pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
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VO2 peak
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cardiorespiratory fitness
기간: pre-surgery (an average of 12 weeks)
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VO2 peak
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pre-surgery (an average of 12 weeks)
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Functional fitness
기간: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Senior's Fitness Test
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Generic quality of life
기간: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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European Organisation for Research and Treatment of Cancer core 30-item questionnaire
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Disease specific quality of life
기간: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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European Organisation for Research and Treatment of Cancer questionnaire module for colorectal cancer
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Symptom burden
기간: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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M.D. Anderson Symptom Inventory
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Exercise motivation
기간: pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Theory of planned behaviour
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pre-NACRT (baseline), post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Eligibility rate
기간: up to 20 months
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Number of eligible patients divided by the number of rectal cancer patients scheduled to receive long-course NACRT
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up to 20 months
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Recruitment rate
기간: up to 20 months
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Number of patients randomized divided by the number of eligible patients
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up to 20 months
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Exercise adherence rate
기간: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Exercise adherence during NACRT will be assessed by the number of exercise sessions attended out of 18 as well as adherence to the intensity and duration of the HIT intervals.
Exercise adherence to the unsupervised exercise after NACRT will be assessed by self-report using the Godin Leisure-Time Exercise.
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post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Follow-up assessment rate
기간: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Number of patients in each group completing the objective outcomes (cardiorespiratory fitness and functional fitness) and patient-reported outcomes (quality of life, symptom burden) at each timepoint.
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post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Safety: Adverse event rate
기간: post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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Number of serious adverse events that occur during exercise testing or the supervised exercise sessions
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post-NACRT (an average of 6 weeks), pre-surgery (an average of 12 weeks)
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Treatment toxicities
기간: every week during NACRT (up to 6 weeks)
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CTCAE Version 3.0
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every week during NACRT (up to 6 weeks)
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Number of patients completing 100% of their planned radiation dose within 1 week of planned completion date
기간: post-NACRT (an average of 6 weeks)
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Obtained from electronic medical records
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post-NACRT (an average of 6 weeks)
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Number of patients receiving ≥ 80% of their planned chemotherapy dose
기간: post-NACRT (an average of 6 weeks)
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Obtained from electronic medical records
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post-NACRT (an average of 6 weeks)
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Pathologic complete response rate
기간: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Length of hospital stay
기간: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Surgical approach
기간: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Ostomy
기간: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
|
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Sphincter preservation
기간: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Blood loss
기간: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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Number of positive lymph nodes
기간: post-surgery (an average of 12 weeks)
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Obtained from electronic medical records
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post-surgery (an average of 12 weeks)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Kerry S Courneya, PhD, University of Alberta
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Joseph K, Nijjar T, Fairchild A, Courneya KS. Feasibility, Safety, and Preliminary Efficacy of Exercise During and After Neoadjuvant Rectal Cancer Treatment: A Phase II Randomized Controlled Trial. Clin Colorectal Cancer. 2021 Sep;20(3):216-226. doi: 10.1016/j.clcc.2021.05.004. Epub 2021 May 26.
- Morielli AR, Boule NG, Usmani N, Tankel K, Joseph K, Severin D, Fairchild A, Nijjar T, Courneya KS. Effects of exercise during and after neoadjuvant chemoradiation on symptom burden and quality of life in rectal cancer patients: a phase II randomized controlled trial. J Cancer Surviv. 2021 Nov 29. doi: 10.1007/s11764-021-01149-w. Online ahead of print.
- Morielli AR, Usmani N, Boule NG, Severin D, Tankel K, Nijjar T, Joseph K, Fairchild A, Courneya KS. Exercise during and after neoadjuvant rectal cancer treatment (the EXERT trial): study protocol for a randomized controlled trial. Trials. 2018 Jan 12;19(1):35. doi: 10.1186/s13063-017-2398-1.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 6월 26일
기본 완료 (실제)
2019년 10월 17일
연구 완료 (실제)
2020년 9월 1일
연구 등록 날짜
최초 제출
2017년 2월 9일
QC 기준을 충족하는 최초 제출
2017년 3월 10일
처음 게시됨 (실제)
2017년 3월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 5월 27일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 5월 24일
마지막으로 확인됨
2022년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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