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Prehabilitation in Rectal Cancer: During Neoadjuvant Therapy vs Preoperative (PREHAREC)

17. mars 2022 oppdatert av: Laura Mora-Lopez, Corporacion Parc Tauli

Randomized Controlled Trial Comparing the Effect of a Multimodal Prehabilitation Program During Neoadjuvant Treatment Versus a Multimodal Prehabilitation After Neoadjuvant Treatment for Patients Undergoing Resection of Rectal Cancer.

Control of the effect of prehabilitation on postoperative morbidity, assessed by the Comprehensive Complication Index (CCI), in patients diagnosed with rectal cancer that will receive neoadjuvant Quimiorradiotherapy (NCRT) and subsequent surgery, performed at the beginning of NCRT or before surgery.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Detaljert beskrivelse

According to the annual report of the Spanish Medical Oncology Association (SEOM), in Spain and without differentiating by sex, colorectal cancer will be the cancer with the highest incidence by 2021; with 43.581 new cases estimated for such year, 14.209 of these will be of rectal cancer. In rectal cancer, surgery remains the cornerstone; however, it is already known that local recurrences are frequent. That is why one of the main milestones rectal cancer treatment, is the multimodal therapy approach. It consists of implementing a neoadjuvant chemoradiotherapy treatment (NCRT) prior to surgical intervention. With this, local control of the disease is achieved, metastases are reduced have resulted in a five-year survival. Subsequently, depending on the definitive pathological results, patients should also complete treatment with postoperative chemotherapy. It is known that patients undergoing neoadjuvant treatment experience a wide variety of side effects, which can cause loss of muscle and cardiovascular function, loss of their functional capacity and increased fatigue. This worsens the quality of life of the patient and can sometimes cause the interruption of neoadjuvant treatment and have repercussions on the prognosis. Not only do these side effects affect the course of neoadjuvant treatment, but also declines the physiological reserve, making the patient arrive in sub-optimal conditions for surgery. This has an impact on postoperative morbidity and mortality, and secondarily, in the increase of hospital stay.

The concept of functional capacity appears ¨as the nutritional, physical and emotional state that a person has to face a stressful situation, such as surgical treatment. It is believed that if functional capacity is enhanced, postoperative morbidity can be reduced and the patient's recovery can also be improved. That is why trimodal programs are created, specifically selected for their potential cumulative or synergistic effects on health outcomes to prepare patients to face surgery at all three levels. These programs are known as prehabilitation.

Currently there are studies that show that prehabilitation improves the results of patients who must undergo different major surgical procedures, among them in colorectal surgery. Our group has recently presented a study that shows that trimodal prehabilitation contributes to reducing postoperative morbidity and overall hospital stay in patients operated on for colorectal neoplasia. There are also systematic reviews that conclude that prehabilitated patients who must undergo major surgery (speaking of 435 patients and 9 studies) present a decrease in the incidence of major postoperative complications. On the other hand, there are studies that show that prehabilitation in patients who must receive neoadjuvant therapy reduces the decrease of functional capacity that treatment produces on patients. As also shown by the Rex Trial, a randomized study on 48 patients. In an attempt to unite the two lines start the study, it will be a novel one , with only two previously published studies in this area. The intention is demonstrate that when prehabilitation is started before commencing neoadjuvant therapy in patients who are diagnosed with rectal cancer and who are subject to neoadjuvant therapy, will reduce the effect on functional capacity, and that patients will present less postoperative morbidity and better postoperative recovery.

Studietype

Intervensjonell

Registrering (Forventet)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Barcelona
      • Sabadell, Barcelona, Spania, 08208
        • Laura Mora López

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patient with rectal tumour and selected to initiate NRCT
  • Patient must know the study and sign informed consent.
  • Patient must accept the conditions necessaries to carry out the prehabilitation.

Exclusion Criteria:

  • Refusal of the patient to sign the informed consent.
  • Baseline pathology that makes it impossible to carry out prehabilitation.
  • Progression of the disease during the study period.
  • Emergency surgery.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: PREHAB-PREOP
PREHABILITATION BEFORE SURGERY
Control of the physical, nutritional and psychological preparation of the patient who will undergo rectal cancer surgery
Eksperimentell: PREHAB-NEOADJ
PREHABILITATION DURING NEOADJUVANCY AND BEFORE SURGERY
Control of the physical, nutritional and psychological preparation of the patient who will undergo rectal cancer surgery

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Comprehension Complication Index (CCI)
Tidsramme: through study completion, an average of 1 yea
Morbidity after surgery of rectal cancer: CCI - value 0-100
through study completion, an average of 1 yea

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
6 minutes walking test (6MWT)
Tidsramme: through study completion, an average of 1 yea
Walking test that helps calculation of the number of daily steps to be carried out (5.000 to 10.000) daily steps
through study completion, an average of 1 yea
Hospital Anxiety and Depression Scale (HADS) test : anxious and depresion scale
Tidsramme: through study completion, an average of 1 yea
Calculation of level of anxiety or depression in mild, moderate or severe. Allows referral of the patient to the psychology service
through study completion, an average of 1 yea

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Laura Mora, Dr, Parc Taulí University Hospital

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

1. mars 2022

Primær fullføring (Forventet)

1. mars 2022

Studiet fullført (Forventet)

1. mars 2025

Datoer for studieregistrering

Først innsendt

9. februar 2022

Først innsendt som oppfylte QC-kriteriene

17. mars 2022

Først lagt ut (Faktiske)

18. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mars 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. mars 2022

Sist bekreftet

1. mars 2022

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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