- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01859442
The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness
Phase 1 Study of Mitochondrial Energetics After Long Course Chemoradiotherapy and a Short Term Exercise Programme in Locally Advanced Rectal Cancer Patients - A Randomized Controlled Trial.
The present study is a randomised control trial investigating the effects of a short six week exercise training program in rectal cancer patients following neoadjuvant chemoradiotherapy prior to elective rectal cancer surgery.
Twelve patients will be randomised (1:1) to an intervention and a control group. The patients randomized to the intervention group will attend a total of 18 tailored exercise sessions (Three 40 minute sessions for six weeks) after their 6 weeks of chemoradiotherapy treatment. Where possible the exercise training sessions will be arranged to fit in with other appointments at the hospital. Patients randomized to the control group will be unsupervised. They will only attend an extra 3 sessions were a cardiopulmonary exercise test and VO2 Kinetics test will be performed. Patients will also be invited to attend 3 health related quality of life interviews at week 0, 3 and 6 during their exercise programme. These appointments will be directly before or after their exercise sessions to minimise hospital attendence.
Following surgery only routine clinically relevant observational data will be collected. These data will relate to hospital length of stay, the level of care required following surgery, post-operative morbidity survey (POMS) and the recovery process. Most of this information can be accessed from patient notes and on the electronic patient records system.
This is a subgroup RCT of patients in a larger interventional trial (6 control and 6 exercise intervention patients) will be asked to consent separately for the the 31-Phosphorus Magnetic Resonance Spectroscopy (31P MRS) scans and the blood samples.
HYPOTHESIS
- Interval exercise training will maintain or improve fitness (measured by anaerobic threshold) in patients undergoing neoadjuvant chemoradiotherapy.
- Interval exercise training is safe and feasible in patients undergoing neoadjuvant chemoradiotherapy awaiting rectal cancer resection.
- Interval exercise training will improve other measures of physical fitness measured in the CPET and the oxygen uptake kinetics test.
- Interval exercise training will improve quality of life in patients undergoing neoadjuvant chemoradiotherapy.
- Improvements in physical fitness will reduce postoperative complications following major rectal cancer surgery.
- Does physical activity, measured by Sensewear Pro 3 activity monitors, decrease during neoadjuvant chemoradiotherapy and can this decrease be attenuated by an exercise training program?
- Can we find an optimal time for surgery when fitness and cancer downstaging are at their best?
HYPOTHESIS for Mechanism Pilot Study
- To explore the exponential rate constant of post-exercise phosphocreatine recovery.
- To explore the alteration in cellular and mitochondrial energetics eg. Change in mitochondrial numbers, change in mitochondrial activity and respiration.
연구 개요
상태
상세 설명
연구 유형
등록 (실제)
단계
- 초기 1단계
연락처 및 위치
연구 장소
-
-
Merseyside
-
Liverpool, Merseyside, 영국, L97Al
- Aintree University Teaching Hospitals NHS FT
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- diagnosis of T3N+ rectal cancer
- above age of 18
- able to conduct a cardiopulmonary exercise test on a cycle ergometer
Exclusion Criteria:
- unable to conduct a cardiopulmonary exercise test on a cycle ergometer
- metastatic disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Exercise group
6 week structured responsive interval exercise training programme
|
|
가짜 비교기: Control group
Negative, unsupervised, out of hospital control group
|
NO intervention in this group, only standard care (no exercise programme)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Exponential rate constant of post-chemoradiotherapy and post-exercise phosphocreatine recovery.
기간: Between baseline and week 0 and between week 0 at week 6 post-NACRT
|
Between baseline and week 0 and between week 0 at week 6 post-NACRT
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Alterations in mitochondrial energetics post-chemoradiotherapy and exercise
기간: Between baseline and week 0 and between week 0 and week 6 post-NACRT
|
Changes in 31- Phosphoromagnetic resonance spectroscopic (31-PMRS) ATP:ADP ratio
|
Between baseline and week 0 and between week 0 and week 6 post-NACRT
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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. .