Perioperative Immunonutrition Intervention on Postoperative Outcomes Among Gynecological Cancer Patients Under Enhanced Recovery After Surgery Setting: A Study Protocol of Explanatory Mixed Method Study

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2024 Dec 31

PMID 39739975

Authors

ChiouYi Ho

Zulfitri Azuan Mat Daud

Barakatun Nisak Mohd Yusof

Hazreen Abdul Majid

Affiliations

Soon will be listed here.

Abstract

Background & Aims: Enhanced Recovery After Surgery (ERAS) has shown significant improvements in postoperative outcomes and a reduction in complications, while immunonutrition (IMN) has been shown to modulate the immune system and inflammatory response. However, many studies have overlooked the crucial aspects of nutrition status and patient perception within the intervention approach. This study aims to investigate the efficacy and explore patients' acceptance of the IMN intervention in postoperative outcomes among gynecological cancer (GC) patients under the ERAS framework.

Methods: This two-phase explanatory sequential mixed-method study design comprises an open-labeled randomized control trial and a qualitative study. The GC participants will be randomly allocated into intervention and control groups. Malaysian adults scheduled for elective surgery will be recruited, with the intervention group receiving IMN for five days before and seven days after elective surgery, while the control group undergoes routine nutritional care before the operation. Both groups will adhere to the ERAS protocol. An explanatory qualitative study will be conducted among GC patients to elucidate their expectations following the trial. Study outcomes include hospitalization duration, change in nutrition status, biochemical profile, functional status, and quality of life. Additionally, the secondary outcome focuses on evaluating the perception of the intervention approach. Quantitative and qualitative data will be analyzed on an intention-to-treat basis and through inductive thematic analysis, respectively.

Conclusion: Implementing perioperative IMN intervention within the ERAS framework may contribute to the preservation of better nutrition status and the provision of sufficient dietary intake to support postoperative recovery, and promote better surgical outcomes. Patients' perceptions play a pivotal role in enhancing understanding of disease management and adherence to the intervention approach.

Trial Registration: NCT06039306.

References

Yi H, Ibrahim Z, Abu Zaid Z, Mat Daud Z, Md Yusop N, Omar J . Impact of Enhanced Recovery after Surgery with Preoperative Whey Protein-Infused Carbohydrate Loading and Postoperative Early Oral Feeding among Surgical Gynecologic Cancer Patients: An Open-Labelled Randomized Controlled Trial. Nutrients. 2020; 12(1). PMC: 7019504. DOI: 10.3390/nu12010264. View

Fearon K, Strasser F, Anker S, Bosaeus I, Bruera E, Fainsinger R . Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011; 12(5):489-95. DOI: 10.1016/S1470-2045(10)70218-7. View

Subramanian M, Kozower B . Immunonutrition in the esophagectomy patient: food for thought. J Thorac Dis. 2019; 11(6):2218-2221. PMC: 6626774. DOI: 10.21037/jtd.2019.05.63. View

Ho C, Ibrahim Z, Abu Zaid Z, Mat Daud Z, Mohd Yusop N, Mohd Abas M . Postoperative Dietary Intake Achievement: A Secondary Analysis of a Randomized Controlled Trial. Nutrients. 2022; 14(1). PMC: 8747030. DOI: 10.3390/nu14010222. View

Soldati L, Di Renzo L, Jirillo E, Ascierto P, Marincola F, De Lorenzo A . The influence of diet on anti-cancer immune responsiveness. J Transl Med. 2018; 16(1):75. PMC: 5859494. DOI: 10.1186/s12967-018-1448-0. View

Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer L . Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019; 29(4):651-668. DOI: 10.1136/ijgc-2019-000356. View

OSullivan D, Sanin D, Pearce E, Pearce E . Metabolic interventions in the immune response to cancer. Nat Rev Immunol. 2019; 19(5):324-335. DOI: 10.1038/s41577-019-0140-9. View

Abeles A, Kwasnicki R, Darzi A . Enhanced recovery after surgery: Current research insights and future direction. World J Gastrointest Surg. 2017; 9(2):37-45. PMC: 5329702. DOI: 10.4240/wjgs.v9.i2.37. View

Mohme M, Riethdorf S, Pantel K . Circulating and disseminated tumour cells - mechanisms of immune surveillance and escape. Nat Rev Clin Oncol. 2016; 14(3):155-167. DOI: 10.1038/nrclinonc.2016.144. View

10.

Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F . ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2016; 36(1):11-48. DOI: 10.1016/j.clnu.2016.07.015. View

11.

McCarthy M, Martindale R . Immunonutrition in Critical Illness: What Is the Role?. Nutr Clin Pract. 2018; 33(3):348-358. DOI: 10.1002/ncp.10102. View

12.

Michie S, van Stralen M, West R . The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011; 6:42. PMC: 3096582. DOI: 10.1186/1748-5908-6-42. View

13.

Di Renzo L, De Lorenzo A, Fontanari M, Gualtieri P, Monsignore D, Schifano G . Immunonutrients involved in the regulation of the inflammatory and oxidative processes: implication for gamete competence. J Assist Reprod Genet. 2022; 39(4):817-846. PMC: 9050992. DOI: 10.1007/s10815-022-02472-6. View

14.

Weiner B, Belden C, Bergmire D, Johnston M . The meaning and measurement of implementation climate. Implement Sci. 2011; 6:78. PMC: 3224582. DOI: 10.1186/1748-5908-6-78. View

15.

Roeland E, Bohlke K, Baracos V, Bruera E, Del Fabbro E, Dixon S . Management of Cancer Cachexia: ASCO Guideline. J Clin Oncol. 2020; 38(21):2438-2453. DOI: 10.1200/JCO.20.00611. View

16.

Mudge L, Watson D, Smithers B, Isenring E, Smith L, Jamieson G . Multicentre factorial randomized clinical trial of perioperative immunonutrition versus standard nutrition for patients undergoing surgical resection of oesophageal cancer. Br J Surg. 2018; 105(10):1262-1272. DOI: 10.1002/bjs.10923. View

17.

Klek S, Szybinski P, Szczepanek K . Perioperative immunonutrition in surgical cancer patients: a summary of a decade of research. World J Surg. 2013; 38(4):803-12. PMC: 3956976. DOI: 10.1007/s00268-013-2323-z. View

18.

Kehlet H, Wilmore D . Multimodal strategies to improve surgical outcome. Am J Surg. 2002; 183(6):630-41. DOI: 10.1016/s0002-9610(02)00866-8. View

19.

Webster J, Kempen L, Hardy R, Langen R . Inflammation and Skeletal Muscle Wasting During Cachexia. Front Physiol. 2020; 11:597675. PMC: 7710765. DOI: 10.3389/fphys.2020.597675. View

20.

Candy B, King M, Jones L, Oliver S . Using qualitative evidence on patients' views to help understand variation in effectiveness of complex interventions: a qualitative comparative analysis. Trials. 2013; 14:179. PMC: 3693880. DOI: 10.1186/1745-6215-14-179. View