Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06103526
Other study ID # 1233456
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 18, 2023
Est. completion date August 30, 2025

Study information

Verified date March 2024
Source National and Kapodistrian University of Athens
Contact Nikolaos Thomakos, MD
Phone +302132162291
Email thomakir@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A patient with oncological pathology of any type because of impaired digestion and nutrient absorption, decreased intake, and increased nutrition requirements has an increased risk of malnutrition and moderate to severe weight loss.In the present study the investigators will evaluate the impact of perioperative immunonutrition supplementation on the postoperative outcomes.


Description:

Malnutrition has a major effect not only on the postoperative course of cancer surgery but can also complicate or even limit administration or compromise the effectiveness of other treatments such as chemotherapy or radiotherapy in the perioperative period. Immunonutrition is a type of artificial nutrition based on the use of some types of macro- or micronutrients.The purpose of this review was to evaluate the use, indications, and effects of these formulas in oncologic surgical patients in real time and to identify the types of patients who can benefit from enteral immunonutrition.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 30, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - women with any gynaecologic malignancy enrolled in surgical list of our institute - must be able to consume oral supplements. Exclusion Criteria: - women that are not able to follow ERAS protocol due to medical reasons - patients with severe disease that cannot compromise with protocol

Study Design


Intervention

Dietary Supplement:
Immunonutrition
enteral supplementation with high amount of proteins, arginine, glutamine, nonessential fatty acids, branched chain fatty acids, nucleotides, or RNA

Locations

Country Name City State
Greece First department of Obstetrics and Gynecology Athens

Sponsors (1)

Lead Sponsor Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

References & Publications (6)

Fiorindi C, Cuffaro F, Piemonte G, Cricchio M, Addasi R, Dragoni G, Scaringi S, Nannoni A, Ficari F, Giudici F. Effect of long-lasting nutritional prehabilitation on postoperative outcome in elective surgery for IBD. Clin Nutr. 2021 Mar;40(3):928-935. doi: 10.1016/j.clnu.2020.06.020. Epub 2020 Jul 1. — View Citation

Gupta R, Senagore A. Immunonutrition within enhanced recovery after surgery (ERAS): an unresolved matter. Perioper Med (Lond). 2017 Dec 11;6:24. doi: 10.1186/s13741-017-0080-5. eCollection 2017. — View Citation

Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704. — 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

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. — View Citation

Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative infections We will notice possible surgical site infections,respiratory inflammations etc and calculate inflammatory markers and the concentration of white blood cells Postoperatively (30 days)
Primary Duration of hospitalization From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months. Until discharge from hospital
Secondary Postoperative mobilization From date of surgery until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months. Until first day of mobilization
Secondary Postoperative morbidity (other than infectious) Major events such as pulmonary embolism,accuse myocardial infarction,etc 30 days
Secondary Recurrence rates Recurrent disease will be monitored through 3 year of follow up 3 years follow-up
Secondary Overall survival Overall survival of the patients will be measured through 3 year of follow up 3 years follow-up
See also
  Status Clinical Trial Phase
Completed NCT04890327 - Web-based Family History Tool N/A
Not yet recruiting NCT05467319 - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS Phase 3
Recruiting NCT05478876 - Carbon Ion Radiation Therapy in the Treatment of Mucous Melanomas of the Female Lower Genital Tract N/A
Active, not recruiting NCT04899492 - Evaluation of Different Smoking Cessation Protocols: Nicotine Replacement, Motivational Interviewing (MI), Cognitive Behavioural Therapy (CBT) or Hypnotherapy in Cancer Patients Scheduled for Surgery N/A
Terminated NCT03658109 - Lidocaine Infusion or Quadratus Lumborum Block and Intrathecal Morphine, Versus Intrathecal Morphine Alone Early Phase 1
Recruiting NCT05296512 - Pembrolizumab and Lenvatinib in Clear Cell Ovarian Cancer Phase 2
Not yet recruiting NCT06398314 - Palliative Radiotherapy in Symptomatic Pelvic Soft Tissue Tumors N/A
Completed NCT01679483 - Efficacy Study of FloSeal for Prevention of Lymphocele After Lymphadenectomy for Gynecologic Cancer N/A
Completed NCT01444924 - Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery Phase 2
Recruiting NCT05053230 - A Study Evaluating the Integrative Medicine at Home (IM@HOME) Program in People With Cancer N/A
Recruiting NCT04534075 - Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial Phase 3
Active, not recruiting NCT04584957 - Prophylactic Negative Pressure Wound Therapy (VAC) in Gynecologic Oncology (G.O.) N/A
Completed NCT03292328 - Yoga for Symptoms of Nerve Damage Caused by Chemotherapy N/A
Completed NCT02459301 - A Dose-Ranging Study of IPH2201 in Patients With Gynecologic Malignancies Phase 1
Completed NCT05131490 - Effect on Adaptation to Cancer of Mobile Application Developed for Gynecological Cancer Patients N/A
Active, not recruiting NCT03899376 - A Trial Comparing Acute Toxicity in Patients With Gynecological Cancer Treated With VMAT N/A
Not yet recruiting NCT05407987 - Ferric Derisomaltose and Outcomes in the Recovery of Gynecologic Oncology: ERAS (Enhanced Recovery After Surgery) Phase 3
Recruiting NCT05891470 - To Explore the Benefits of the MonaLisa Touch® System in Gynaecological Cancer Patients Treated by (Chemo)-RT N/A
Not yet recruiting NCT05974995 - Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer N/A
Withdrawn NCT04368130 - SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care N/A