CClinicalTrials.gg
Status unknownNCT05286086PREHARECUpdated Mar 18, 2022

Prehabilitation in Rectal Cancer: During Neoadjuvant Therapy vs Preoperative

An interventional study of prehabilitation in Rectal Cancer, Adenocarcinoma and Chemoradiotherapy, sponsored by Corporacion Parc Tauli. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Corporacion Parc Tauli · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Rectal Cancer, Adenocarcinoma
  • Chemoradiotherapy

Browse trials for

Keywords

  • RECTAL CANCER
  • PREAHBILITATION
  • NEOADJUVANCY
  • COMPREHENSION COMPLICATION INDEX
03

In context

Rectal Neoplasms

1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.

This study's planned enrollment of 50 is below the median of 65 across 1,297 interventional studies indexed under Rectal Neoplasms.

Browse Rectal Neoplasms studies →

Lead sponsor

Corporacion Parc Tauli is the lead sponsor of 163 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Sham comparator
    PREHAB-PREOP

    PREHABILITATION BEFORE SURGERY

    Behavioral: prehabilitation

  • Experimental
    PREHAB-NEOADJ

    PREHABILITATION DURING NEOADJUVANCY AND BEFORE SURGERY

    Behavioral: prehabilitation

Interventions

  • Behavioralprehabilitation

    Control of the physical, nutritional and psychological preparation of the patient who will undergo rectal cancer surgery

06

What researchers measure

Primary outcomes

  1. Comprehension Complication Index (CCI)

    Morbidity after surgery of rectal cancer: CCI - value 0-100

    Time frame: through study completion, an average of 1 yea

Secondary outcomes

  1. 6 minutes walking test (6MWT)

    Walking test that helps calculation of the number of daily steps to be carried out (5.000 to 10.000) daily steps

    Time frame: through study completion, an average of 1 yea

  2. Hospital Anxiety and Depression Scale (HADS) test : anxious and depresion scale

    Calculation of level of anxiety or depression in mild, moderate or severe. Allows referral of the patient to the psychology service

    Time frame: through study completion, an average of 1 yea

07

Study locations

1 site
08

References and documents

Publications

  • Berho M, Narang R, Van Koughnett JA, Wexner SD. Modern multidisciplinary perioperative management of rectal cancer. JAMA Surg. 2015 Mar 1;150(3):260-6. doi: 10.1001/jamasurg.2014.2887. PubMed 25629513 ↗
  • Herman JM, Narang AK, Griffith KA, Zalupski MM, Reese JB, Gearhart SL, Azad NS, Chan J, Olsen L, Efron JE, Lawrence TS, Ben-Josef E. The quality-of-life effects of neoadjuvant chemoradiation in locally advanced rectal cancer. Int J Radiat Oncol Biol Phys. 2013 Jan 1;85(1):e15-9. doi: 10.1016/j.ijrobp.2012.09.006. Epub 2012 Oct 9. PubMed 23058059 ↗
  • Pramateftakis MG, Kanellos D, Tekkis PP, Touroutoglou N, Kanellos I. Rectal cancer: multimodal treatment approach. Int J Surg Oncol. 2012;2012:279341. doi: 10.1155/2012/279341. Epub 2012 Sep 12. No abstract available. PubMed 23008766 ↗
  • Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9. PubMed 30025745 ↗
  • Wright S, Wiechula R, McLiesh P. The effectiveness of prehabilitation for adults having elective surgery: a systematic review protocol. JBI Database System Rev Implement Rep. 2016 Feb;14(2):78-92. doi: 10.11124/jbisrir-2016-2460. No abstract available. PubMed 27536795 ↗
  • Santa Mina D, van Rooijen SJ, Minnella EM, Alibhai SMH, Brahmbhatt P, Dalton SO, Gillis C, Grocott MPW, Howell D, Randall IM, Sabiston CM, Silver JK, Slooter G, West M, Jack S, Carli F. Multiphasic Prehabilitation Across the Cancer Continuum: A Narrative Review and Conceptual Framework. Front Oncol. 2021 Jan 11;10:598425. doi: 10.3389/fonc.2020.598425. eCollection 2020. PubMed 33505914 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05286086
Lead sponsor
Corporacion Parc Tauli
Responsible party
Laura Mora-Lopez (PhD, MD, Colorrectal Surgeon, Associate Professor, Corporacion Parc Tauli) — Principal investigator
First posted
Mar 18, 2022
Start date
Mar 2022 (estimated)
Primary completion
Mar 2022 (estimated)
Completion
Mar 2025 (estimated)
Last update
Mar 18, 2022

Study contacts

Laura Mora
Contact
mora.lopez.laura@gmail.com
34 937211010 ext. 21490
Laura Mora, Dr
Contact
mora.lopez.laura@gmail.com
34 937211010 ext. 21490
Laura Mora, Dr
principal investigator · Parc Tauli University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion