Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Effect of Cancer Therapies and Exercise on Mitochondrial Energetics and Fitness

5. maj 2014 opdateret af: Michelle Mossa

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

  1. Interval exercise training will maintain or improve fitness (measured by anaerobic threshold) in patients undergoing neoadjuvant chemoradiotherapy.
  2. Interval exercise training is safe and feasible in patients undergoing neoadjuvant chemoradiotherapy awaiting rectal cancer resection.
  3. Interval exercise training will improve other measures of physical fitness measured in the CPET and the oxygen uptake kinetics test.
  4. Interval exercise training will improve quality of life in patients undergoing neoadjuvant chemoradiotherapy.
  5. Improvements in physical fitness will reduce postoperative complications following major rectal cancer surgery.
  6. 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?
  7. Can we find an optimal time for surgery when fitness and cancer downstaging are at their best?

HYPOTHESIS for Mechanism Pilot Study

  1. To explore the exponential rate constant of post-exercise phosphocreatine recovery.
  2. To explore the alteration in cellular and mitochondrial energetics eg. Change in mitochondrial numbers, change in mitochondrial activity and respiration.

Studieoversigt

Detaljeret beskrivelse

All patients will attend 5 sets of appointments at the hospital for diagnostic tests and 3 appointments at the University of Liverpool Magnetic Resonance and Image Analysis Research Centre (MARIARC). Three appointments will be prior to chemoradiotherapy treatment, and the other 4 will be after chemoradiotherapy. Two of these 5 appointments are part of routine care. The first 4 appointments will last about an hour. Patients will complete 3 quality of life questionnaires on recruitment, during chemotherapy, before and 4-6 weeks after surgery. These 3 questionnaires will take 20 minutes to fill in. The fourth and fifth appointments will consist of Computed Tomogram (CT) and Magnetic Resonance Imaging (MRI) scans in our radiology department to assess cancer staging. These appointments will last about 1 hour 30 minutes.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Merseyside
      • Liverpool, Merseyside, Det Forenede Kongerige, L97Al
        • Aintree University Teaching Hospitals NHS FT

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Exercise group
6 week structured responsive interval exercise training programme
Sham-komparator: Control group
Negative, unsupervised, out of hospital control group
NO intervention in this group, only standard care (no exercise programme)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Exponential rate constant of post-chemoradiotherapy and post-exercise phosphocreatine recovery.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Alterations in mitochondrial energetics post-chemoradiotherapy and exercise
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Samarbejdspartnere

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2012

Primær færdiggørelse (Faktiske)

1. juli 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

13. maj 2013

Først indsendt, der opfyldte QC-kriterier

17. maj 2013

Først opslået (Skøn)

22. maj 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. maj 2014

Sidst verificeret

1. september 2013

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner