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.
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)
Women with performance status: ECOG >2 and ASA score >III
Women who have not been informed and have given written consent
Parallel
Ocoxin
Dietary supplementFood Supplement based on Amino Acids, Plants, Vitamins and Minerals. Composition: Maltodextrin, L-Arginine, L-Cysteine, Microcrystalline cellulose, Talcum, Vitamin C (L-ascorbic acid), Zinc sulfate, Green Tea Extract (Camellia sinensis (L.) Kuntze), Manganese sulphate, Extracto de Canela (Cinnamomum verum J. Presl.), Vitamin B6 (pyridoxine hydrochloride). Ocoxin utilizes Catalysis' Molecular Activation Technology (MAT) to enhance the biological activity of its natural antioxidant ingredients, such as green tea polyphenols (EGCG), to increase their antitumoral and immunomodulatory effects. This patented technology is applied to boost the efficacy of compounds within Ocoxin, such as EGCG, enabling them to exert more potent effects on cancer cells by inducing apoptosis, inhibiting tumor growth and metastasis, and supporting the body's immune response.
Structured self-guided exercise
Procedure/SurgeryThe patient exercises in a structured manner with the help of a relevant interactive form/guide and simple aids (e.g. chair, step, water bottle, broomstick) by performing six categories of exercises: 1. Breathing exercises, 2. Pelvic floor exercises-pelvic mobility, 3. Upper trunk exercises, 4. Lower trunk exercises, 5. Aerobic exercises, 6. Stretching exercises, at a predetermined pace (number of repetitions) of each exercise and a limit of not exceeding the value 5-6 on the ten-point modified Borg fatigue scale. The intern records her activity on a form-"exercise log". The recommendation is the maximum implementation of the exercise program but in any case not less than 3 times a week.
Postoperative morbidity
Systematic recording of complications based on the Clavien Dindo system, during hospitalization and in the immediate postoperative period (up to the 30th postoperative day).
Duration of hospitalization
The discharge day is defined as the postoperative day on which the following criteria are met in their entirety: 1. adequate mobilization, 2. tolerance of solid foods and adequate oral water intake, 3. adequate analgesia only with oral analgesics, 4. mobilization of intestinal function / flatus, 5. Absence of Clavien Dindo \>II complication.
General Quality of Life (QoL)
Use of metric tools: structured and weighted questionnaires in Greek language EORTC QLQ-C30 (version 3.0) (general quality of life). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time interval between the onset of adjuvant anti-neoplastic therapy
The number of days between the day of surgery and the start of adjuvant therapy (includes systemic chemotherapy/immunotherapy, external radiation, brachytherapy).
Hospital readmission at 90 days
Any admission to a nursing facility up to the 90th postoperative day.
Cachexia
Assessments using unique measurements EORTC QLQ-CAX24 (cachexia). The Cancer Cachexia Module is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-CAX24 incorporates five multi-item scales to assess food aversion, eating and weight-loss worry, eating difficulties, loss of control, and physical decline. In addition, four single items assess dry mouth, indigestion/heartburn, forcing self to eat and inadequate information. All of the scales and single-item measures range in score from 0 to 100. A high score for the symptom scales represents a high level of symptomatology or problems.
Sexual Health
The EORTC Quality of Life Questionnaire Sexual Health (SH-22) is a stand-alone questionnaire, but can also be used as a supplementary questionnaire to be employed in conjunction with the QLQ-C30. The SH-22 incorporates 2 multi-item scales to assess Sexual satisfaction and Sexual pain. In addition, 11 single items assess sexual activity and cover treatment-related and partner-related questions, general questions of sexual health and 4 gender specific questions. Interpretation: All of the Multi-item scales and Single-item measures range in score from 0 to 100. A high score represents a high level of symptomatology or problems. Reporting: The two multi-item scales have a different number of items depending on whether the patient had or does not have a partner, and has or does not have sexual activity. It is advised to always report how many items were used to calculate each scale; and which ones. This will allow comparison between different subgroups of patients.
Click on the lead sponsor to view all of their trials.
Aristotle University Of Thessaloniki
Lead sponsor
Catalysis SL
Collaborator
