Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Catalysis SL | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
The purpose of this study is to investigate the impact of multifactorial preoperative empowerment (pre-habilitation protocol) on patients with gynecological cancer who undergo oncological surgery. The objective of this study is to demonstrate whether the implementation of pre-habilitation program empowerment as opposed to its non-implementation leads to an improvement in quality of life, a reduction in days of hospitalization, a reduction in immediate (up to discharge) and long term (up to 40th post-surgery day) postoperative complications (as measured with the Clavien Dindo system), a reduction in hospital readmission rates, and postoperative morbidity and mortality.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation group | Experimental | 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 . |
|
| Control group | No Intervention | 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 . |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocoxin | Dietary Supplement | Food 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to the 30th post operative 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. | Until the patient discharged (assessed up to 4 days) |
| 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. | Up to the time of discharge (assessed up to 4 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 120 days after surgery |
| Hospital readmission at 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dimitrios Tsolakidis C. MD, PhD, Professor OB&GYN | Contact | +30 2313 32 3380 | dtgyn@auth.gr | |
| Panagiotis Tzitzis M. MD, MSc | Contact | +30 6946621179 | ptzitzis@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dimitrios C. Tsolakidis, MD, PhD | Professor of Obstetrics - Gynaecology, Aristotel University of Thessaloniki | Study Chair |
| Panagiotis M. Tzitzis, MD, MSc | PhD (c) 1st Department of Obstetrics - Gynaecology Aristotel University of Thessaloniki |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Papageorgiou | Recruiting | Thessaloniki | 56429 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26603969 | Background | 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. | |
| 31473663 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Structured self-guided exercise | Procedure | The 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. |
|
Any admission to a nursing facility up to the 90th postoperative day. |
| 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. | Up to the time of discharge (assessed up to 5 days) |
| 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. | Up to the time of discharge (assessed up to 4 days) |
| Quality of Life in ovarian cancer | The Ovarian Cancer Module (QLQ-OV28) is a supplementary questionnaire module to be employed in conjunction with the QLQ-C30. The QLQ-OV28 incorporates seven multi-item scales to assess body image, sexuality, attitude to disease or treatment, abdominal or gastro-intestinal symptoms, peripheral neuropathy, hormonal or menopausal symptoms and other chemotherapy side-effects. The scoring approach for the QLQ-OV28 is identical in principle to that for the [function and/or symptom scales / single items] of the QLQ-C30. Interpretation: All of the scales and single-item measures range in score from 0 to 100. A high score for the [functional scales and/or single items] represents a high level of functioning, whereas a high score for the [symptom scales and/or single items] represents a high level of symptomatology or problems. | Up to the time of discharge (assessed up to 4 days) |
| Quality of Life in endometrial cancer | The Endometrial Cancer Module (QLQ-EN24) is a supplementary questionnaire module designed for patients with all stages of endometrial cancer and should always be employed in conjunction with the QLQ-C30. The QLQ-EN24 incorporates 5 multi-item scales to assess lymphoedema, urological symptoms, gastrointestinal symptoms, body image and sexual/vaginal problems. In addition, 8 single items assess pain in back and pelvis, tingling/numbness, muscular pain, hair loss, taste change, sexual interest, sexual activity and sexual enjoyment. The scoring approach for the QLQ-EN24 is identical in principle to that for the symptom scales/single-items of the QLQ-C30. Interpretation: All of the scales and single-item measures range in score from 0 to 100. A high score for the functional items represents a high level of functioning, whereas a high score for the symptom scales and single-items represents a high level of symptomatology or problems. | Up to the time of discharge (assessed up to 4 days) |
| Background |
| 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. |
| 26757238 | Background | 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. |
| 32826114 | Background | Hubner M, Kusamura S, Villeneuve L, Al-Niaimi A, Alyami M, Balonov K, Bell J, Bristow R, Guiral DC, Fagotti A, Falcao LFR, Glehen O, Lambert L, Mack L, Muenster T, Piso P, Pocard M, Rau B, Sgarbura O, Somashekhar SP, Wadhwa A, Altman A, Fawcett W, Veerapong J, Nelson G. Guidelines for Perioperative Care in Cytoreductive Surgery (CRS) with or without hyperthermic IntraPEritoneal chemotherapy (HIPEC): Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations - Part II: Postoperative management and special considerations. Eur J Surg Oncol. 2020 Dec;46(12):2311-2323. doi: 10.1016/j.ejso.2020.08.006. Epub 2020 Aug 13. |
| 33388155 | Background | Bisch SP, Jago CA, Kalogera E, Ganshorn H, Meyer LA, Ramirez PT, Dowdy SC, Nelson G. Outcomes of enhanced recovery after surgery (ERAS) in gynecologic oncology - A systematic review and meta-analysis. Gynecol Oncol. 2021 Apr;161(1):46-55. doi: 10.1016/j.ygyno.2020.12.035. Epub 2020 Dec 30. |
| 36898697 | Background | Miralpeix E, Fabrego B, Rodriguez-Cosmen C, Sole-Sedeno JM, Gayete S, Jara-Bogunya D, Corcoy M, Mancebo G. Prehabilitation in an ERAS program for endometrial cancer patients: impact on post-operative recovery. Int J Gynecol Cancer. 2023 Apr 3;33(4):528-533. doi: 10.1136/ijgc-2022-004130. |
| 36047379 | Background | Ferrero A, Vassallo D, Geuna M, Fuso L, Villa M, Badellino E, Barboni M, Coata P, Santoro N, Delgado Bolton RC, Biglia N. Immunonutrition in ovarian cancer: clinical and immunological impact? J Gynecol Oncol. 2022 Nov;33(6):e77. doi: 10.3802/jgo.2022.33.e77. Epub 2022 Aug 12. |
| 27931879 | Background | Prieto I, Montemuino S, Luna J, de Torres MV, Amaya E. The role of immunonutritional support in cancer treatment: Current evidence. Clin Nutr. 2017 Dec;36(6):1457-1464. doi: 10.1016/j.clnu.2016.11.015. Epub 2016 Nov 24. |
| 30877144 | Background | 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. |
| 37086524 | Background | Nelson G, Fotopoulou C, Taylor J, Glaser G, Bakkum-Gamez J, Meyer LA, Stone R, Mena G, Elias KM, Altman AD, Bisch SP, Ramirez PT, Dowdy SC. Enhanced recovery after surgery (ERAS(R)) society guidelines for gynecologic oncology: Addressing implementation challenges - 2023 update. Gynecol Oncol. 2023 Jun;173:58-67. doi: 10.1016/j.ygyno.2023.04.009. Epub 2023 Apr 21. |
| 31100877 | Background | Bisch S, Nelson G, Altman A. Impact of Nutrition on Enhanced Recovery After Surgery (ERAS) in Gynecologic Oncology. Nutrients. 2019 May 16;11(5):1088. doi: 10.3390/nu11051088. |
| 27637832 | Background | Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6. |
| 35406407 | Background | Diaz-Feijoo B, Agusti-Garcia N, Sebio R, Lopez-Hernandez A, Siso M, Glickman A, Carreras-Dieguez N, Fuste P, Marina T, Martinez-Egea J, Aguilera L, Perdomo J, Pelaez A, Lopez-Baamonde M, Navarro-Ripoll R, Gimeno E, Campero B, Torne A, Martinez-Palli G, Arguis MJ. Feasibility of a Multimodal Prehabilitation Programme in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer: A Pilot Study. Cancers (Basel). 2022 Mar 23;14(7):1635. doi: 10.3390/cancers14071635. |
| 37208019 | Background | Inci MG, Sehouli J, Schnura E, Lee M, Roll S, Reinhold T, Klews J, Kaufner L, Niggemann P, Groeben H, Toelkes J, Reisshauer A, Liebl M, Daehnert E, Zimmermann M, Knappe-Drzikova B, Rolker S, Nunier B, Algharably E, Pirmorady Sehouli A, Zwantleitner L, Krull A, Heitz F, Ataseven B, Chekerov R, Harter P, Schneider S. The KORE-INNOVATION trial, a prospective controlled multi-site clinical study to implement and assess the effects of an innovative peri-operative care pathway for patients with ovarian cancer: rationale, methods and trial design. Int J Gynecol Cancer. 2023 Aug 7;33(8):1304-1309. doi: 10.1136/ijgc-2023-004531. |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000611825 | Ocoxin |
Not provided
Not provided
Not provided