Prehabilitation With Exercise and Immunonutrition (Ocoxin®) in the Perioperative Management of Gynecologic Malignancies Under ERAS Protocol.

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

ERAS (Enhanced Recovery After Surgery) protocols are step-by-step care plans that help patients recover faster after surgery. They focus on keeping the body's normal functions, lowering stress from surgery, and supporting a quicker recovery. In gynecologic cancer surgeries, ERAS has been shown to help patients do better, have fewer problems, and leave the hospital sooner. A prehabilitation program, in combination with ERAS protocols, aims to optimize patients' physical and psychological condition prior to surgery for gynecological cancers. Interventions may include tailored exercise, nutritional support, respiratory training, and psychological preparation. By enhancing baseline fitness and resilience, prehabilitation improves the body's ability to tolerate surgical stress, reduces complications, and facilitates a faster, smoother recovery within the ERAS framework.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Type of gynecological malignancy: endometrial cancer, ovarian cancer, cervical cancer, treated with laparotomy after the decision of the gynecological-oncology unit (positive opinion of the Multidisciplinary Tumor Board - MDT)

• Patient age: 18 to 85 years

• General condition of the patient: ASA score I-III

• Consent to implement the accelerated recovery protocol - Enhanced recovery after surgery (ERAS)

• Sufficient understanding of the Greek language

• Provision of signed, after thorough information, consent to participate in the study

Locations
Other Locations
Greece
General Hospital of Papageorgiou
RECRUITING
Thessaloniki
Contact Information
Primary
Dimitrios Tsolakidis C. MD, PhD, Professor OB&GYN
dtgyn@auth.gr
+30 2313 32 3380
Backup
Panagiotis Tzitzis M. MD, MSc
ptzitzis@gmail.com
+30 6946621179
Time Frame
Start Date: 2025-12-01
Estimated Completion Date: 2029-12-30
Participants
Target number of participants: 100
Treatments
Experimental: Prehabilitation group
This group undergo a structured preoperative self-guided exercise protocol (consisting of mild physical activity with a defined exercise program, respiratory exercise, muscle strengthening), immunonutrition (Ocoxin©) and usual clinical practice (stopping alcohol, regulating anemia and glucose levels). During the period of hospitalatization adhere to the 21-point ERAS protocol .
No_intervention: Control group
This group follow the usual clinical practice (stopping alcohol, regulating anemia and glucose levels). During the period of hospitalatization adhere to the 21-point ERAS protocol .
Related Therapeutic Areas
Sponsors
Collaborators: Catalysis SL
Leads: Aristotle University Of Thessaloniki

This content was sourced from clinicaltrials.gov

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