Chemoradiotherapy Clinical Trial
— PREHARECOfficial 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.
NCT number | NCT05286086 |
Other study ID # | PREHAREC |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2022 |
Est. completion date | March 2025 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Laura Mora López | Sabadell | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Corporacion Parc Tauli |
Spain,
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
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 |
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