Prehabilitation Plus ERAS Versus ERAS in Gynecologic Oncology: a Randomized Clinical Trial

Gynecologic Cancer Clinical Trial

— PROPER  

Official title:

Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecologic Oncology: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04596800
• Other study ID #: 36924620.7.0000.0072
• Status: Recruiting
• Phase: Phase 3
• Start date: November 5, 2020
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: Instituto Brasileiro de Controle do Cancer
• Contact: Andre Lopes, MD
• Phone: +551134744242
• Email: andrelopes.cirurgia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, interventionist, controlled and randomized study to test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery.

Description:

Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to multidisciplinary team and blind to surgeons and anaesthesiologists. The aim is test the effectiveness of a multimodal prehabilitation protocol in patients who will undergo gynecological surgery. The multidisciplinary prehabilitation program will be applied to the intervention group. For the group participating in the prehabilitation and for the control group, specific recommendations for gynecological cancer defined by the Enhanced Recovery After Surgery (ERAS®) guidelines will be applied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients who sign the Informed Consent Form, indicating that they understand the study procedures and their purpose;
• Women aged between 18 and 80 years old;
• Gynecological surgery performed by laparotomy;
• Patients with Eastern Cooperative Oncology Group Performance Status of at least 2 (ECOG =2);
• Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks

Exclusion Criteria:

• Patients under 18 or older than 80 years old;
• ECOG =3;
• Significant comorbidities, such as: neurological or musculoskeletal disorder, heart disease and / or respiratory failure that prohibit physical exercise;
• Limitation of ambulation preventing the patient to perform physical exercises;
• Cognitive deterioration or patients with psychiatric disorder that prevents adherence to the program;
• Emergency or urgency surgeries;
• Surgeries by minimally invasive approach (laparoscopy or robotics);
• Vulvectomy or soft tissue surgery without abdominal approach;
• Minor gynaecological surgeries such as conizations;
• Surgeries performed together with other specialties, in which the gynecology team is not primarily responsible for postoperative care;
• If surgery is performed 21 days after the last day of the prehabilitation program, for any reason

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Gynecologic Cancer

Intervention

Other:
• Prehabilitation Program + Enhanced Recovery After Surgery
Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
• Enhanced Recovery After Surgery
ERAS

Locations

Country	Name	City	State
Brazil	Instituto Brasileiro de Controle do Cancer - IBCC	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Brasileiro de Controle do Cancer

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293. — View Citation

Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393. — View Citation

Iyer R, Gentry-Maharaj A, Nordin A, Burnell M, Liston R, Manchanda R, Das N, Desai R, Gornall R, Beardmore-Gray A, Nevin J, Hillaby K, Leeson S, Linder A, Lopes A, Meechan D, Mould T, Varkey S, Olaitan A, Rufford B, Ryan A, Shanbhag S, Thackeray A, Wood N, Reynolds K, Menon U. Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecological oncology surgical outcomes and complications). Br J Cancer. 2015 Feb 3;112(3):475-84. doi: 10.1038/bjc.2014.630. Epub 2014 Dec 23. — View Citation

Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003. — View Citation

Miralpeix E, Mancebo G, Gayete S, Corcoy M, Sole-Sedeno JM. Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program. Int J Gynecol Cancer. 2019 Oct;29(8):1235-1243. doi: 10.1136/ijgc-2019-000597. Epub 2019 Aug 30. — View Citation

Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available. — View Citation

Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available. — View Citation

Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15. — View Citation

Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative recovery time	Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs	Up to 30 postoperative days
Secondary	Complications and Adverse Effects	Complications and Adverse Effects according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 2017	Up to 30 postoperative days
Secondary	Readmissions	Readmission to the Hospital Facilities	Up to 30 postoperative days
Secondary	Intensive Care Unit admission rates	Postoperative Intensive Care Unit admission and stay	Up to 30 postoperative days
Secondary	Health-related Quality of Life	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)	At Baseline, the week before surgery, then at postoperative days 7, 30 and 60
Secondary	Compliance to the ERAS® program guideline	Compliance to ERAS® protocol and implementation of the program	Up to 30 postoperative days
Secondary	Changes in anxiety and depression from baseline	Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.	At Baseline, the week before surgery, then at postoperative days 7, 30 and 60
Secondary	Changes in functional capacity from baseline	Patients will perform a 6-Minute Walk Test	At Baseline, the week before surgery, then at postoperative days 30 and 60
Secondary	Change in muscle strength	Muscle strength is measured by using an dynamometer	At Baseline, the week before surgery, then at postoperative days 30 and 60
Secondary	Change in body mass	Body mass is measured by using a bioelectrical impedance analysis	At Baseline, the week before surgery, then at postoperative days 30 and 60
Secondary	Hospital stay	Days from surgical procedure to hospital discharge	Up to 30 days
Secondary	Use of opioids in acute postoperative pain	Use and dosage of opioids in the postoperative period	Up to 30 days