Prehabilitation in Rectal Cancer: During Neoadjuvant Therapy vs Preoperative

Chemoradiotherapy Clinical Trial

— PREHAREC  

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05286086
• Other study ID #: PREHAREC
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: March 2025

Study information

• Verified date: March 2022
• Source: Corporacion Parc Tauli
• Contact: Laura Mora
• Phone: 34 937211010
• Email: mora.lopez.laura[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2025
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chemoradiotherapy
• Rectal Cancer, Adenocarcinoma
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Spain	Laura Mora López	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. Review. — View Citation

Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SÈ, 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 — View Citation

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. — View Citation

Pramateftakis MG, Kanellos D, Tekkis PP, Touroutoglou N, Kanellos I. Rectal cancer: multimodal treatment approach. Int J Surg Oncol. 2012;2012:279341. Epub 2012 Sep 12. — View Citation

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehension Complication Index (CCI)	Morbidity after surgery of rectal cancer: CCI - value 0-100	through study completion, an average of 1 yea
Secondary	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	through study completion, an average of 1 yea
Secondary	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	through study completion, an average of 1 yea