Nutritional Psychological Intervention and Vomit-free Management on Survival and Quality of Life in Advanced Gastrointestinal Tumors

NCT06223230 | Recruiting DMC

• 1 other identifier: WDRY2022-K092
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief Summary

Aims to observe and evaluate the impact of survival and quality of life of patients with gastrointestinal tumors such as advanced esophageal, gastric, liver, pancreatic, and colorectal cancers through nutritional-psychological interventions versus no-vomit management compared to standard antitumor therapy alone

Conditions

Digestive System Cancer; Digestive System Neoplasm

Outcome Measures

Primary Outcomes (1)

• Median progression-free survival time

  Progression-free survival is defined as the period from the date of treatment to the date of the first occurrence of disease progression or death from any cause, whichever occurs first. Median progression-free survival is the time to progression-free survival that corresponds to when the cumulative progression-free survival rate is 0.5, indicating that 50% of individuals will live through this time without disease progression.

  Approximately 40 months from date of the first participant randomization

Secondary Outcomes (6)

• completion rate

  Approximately 40 months from date of the first participant randomization

• Quality of Life(QoL)

  Approximately 40 months from date of the first participant randomization

• median Overall Survival

  Approximately 40 months from date of the first participant randomization

• Disease Control Rate

  Approximately 40 months from date of the first participant randomization

• Objective Response Rate

  Approximately 40 months from date of the first participant randomization

Study Arms (2)

Study group

EXPERIMENTAL

First-line treatment received standard antitumor therapy and nutritional psychological interventions with and without vomit management

Other: Nutritional psychological interventions and vomit-free management

Control group

NO INTERVENTION

First-line treatment receives standard antitumor therapy

Interventions

Nutritional psychological interventions and vomit-free management OTHER

Nutritional psychological interventions and vomit-free management

Study group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75, male or female;
• Patients with advanced esophageal cancer, gastric cancer, liver cancer and colorectal cancer and other gastrointestinal tumors diagnosed by pathological histology or cytology;
• Expected survival ³ 8 weeks and able to receive long-term follow-up;
• Eastern Cooperative Oncology Group(ECOG)-Performance Status(PS) score of 0-2;
• First-line treatment receiving standard oncology treatment and nutritional psychological intervention and vomit-free management group (study group); first-line treatment receiving only standard oncology treatment group (control group);
• Voluntarily signing an informed consent form.

You may not qualify if:

• Other malignant tumors diagnosed within the previous 5 years, except for effectively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or effectively resected in situ cervical cancer or breast cancer;
• history of psychiatric illness prior to the diagnosis of the tumor
• patients who resist treatment
• patients with poorly controlled severe heart disease, liver or kidney insufficiency, severe anemia, multiple lymph node enlargement, leukopenia, etc;
• patients who are pregnant or have a pregnancy plan;

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin hosptial of Wuhan University

Wuhan, Hubei, 430060, China

RECRUITING

Related Publications (11)

• Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  PMID: 30207593 RESULT

• Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.

  PMID: 26808342 RESULT

• McCreery E, Costello J. Providing nutritional support for patients with cancer cachexia. Int J Palliat Nurs. 2013 Jan;19(1):32-7. doi: 10.12968/ijpn.2013.19.1.32.

  PMID: 23354431 RESULT

• Caillet P, Liuu E, Raynaud Simon A, Bonnefoy M, Guerin O, Berrut G, Lesourd B, Jeandel C, Ferry M, Rolland Y, Paillaud E. Association between cachexia, chemotherapy and outcomes in older cancer patients: A systematic review. Clin Nutr. 2017 Dec;36(6):1473-1482. doi: 10.1016/j.clnu.2016.12.003. Epub 2016 Dec 18.

  PMID: 28017447 RESULT

• Unsal D, Mentes B, Akmansu M, Uner A, Oguz M, Pak Y. Evaluation of nutritional status in cancer patients receiving radiotherapy: a prospective study. Am J Clin Oncol. 2006 Apr;29(2):183-8. doi: 10.1097/01.coc.0000198745.94757.ee.

  PMID: 16601440 RESULT

• Hill A, Kiss N, Hodgson B, Crowe TC, Walsh AD. Associations between nutritional status, weight loss, radiotherapy treatment toxicity and treatment outcomes in gastrointestinal cancer patients. Clin Nutr. 2011 Feb;30(1):92-8. doi: 10.1016/j.clnu.2010.07.015. Epub 2010 Aug 17.

  PMID: 20719409 RESULT

• Bourdeanu L, Frankel P, Yu W, Hendrix G, Pal S, Badr L, Somlo G, Luu T. Chemotherapy-induced nausea and vomiting in Asian women with breast cancer receiving anthracycline-based adjuvant chemotherapy. J Support Oncol. 2012 Jul-Aug;10(4):149-54. doi: 10.1016/j.suponc.2011.10.007. Epub 2012 Jan 4.

  PMID: 22222249 RESULT

• Serafini M, Jakszyn P, Lujan-Barroso L, Agudo A, Bas Bueno-de-Mesquita H, van Duijnhoven FJ, Jenab M, Navarro C, Palli D, Boeing H, Wallstrom P, Regner S, Numans ME, Carneiro F, Boutron-Ruault MC, Clavel-Chapelon F, Morois S, Grioni S, Panico S, Tumino R, Sacerdote C, Ramon Quiros J, Molina-Montes E, Huerta Castano JM, Barricarte A, Amiano P, Khaw KT, Wareham N, Allen NE, Key TJ, Jeurnink SM, Peeters PH, Bamia C, Valanou E, Trichopoulou A, Kaaks R, Lukanova A, Bergmann MM, Lindkvist B, Stenling R, Johansson I, Dahm CC, Overvad K, Jensen M, Olsen A, Tjonneland A, Lund E, Rinaldi S, Michaud D, Mouw T, Riboli E, Gonzalez CA. Dietary total antioxidant capacity and gastric cancer risk in the European prospective investigation into cancer and nutrition study. Int J Cancer. 2012 Aug 15;131(4):E544-54. doi: 10.1002/ijc.27347. Epub 2012 Jan 31.

  PMID: 22072493 RESULT

• Kolawole OM, Olatunji KT, Durowade KA. Molecular detection of human papillomavirus from abnormal cervical cytology of women attending a tertiary health facility in Ido-ekiti, southwest Nigeria. J Prev Med Hyg. 2016;57(2):E86-90.

  PMID: 27582634 RESULT

• Shitara K, Chin K, Yoshikawa T, Katai H, Terashima M, Ito S, Hirao M, Yoshida K, Oki E, Sasako M, Emi Y, Tsujinaka T. Phase II study of adjuvant chemotherapy of S-1 plus oxaliplatin for patients with stage III gastric cancer after D2 gastrectomy. Gastric Cancer. 2017 Jan;20(1):175-181. doi: 10.1007/s10120-015-0581-1. Epub 2015 Dec 1.

  PMID: 26626800 RESULT

• Climent M, Munarriz M, Blazeby JM, Dorcaratto D, Ramon JM, Carrera MJ, Fontane L, Grande L, Pera M. Weight loss and quality of life in patients surviving 2 years after gastric cancer resection. Eur J Surg Oncol. 2017 Jul;43(7):1337-1343. doi: 10.1016/j.ejso.2017.01.239. Epub 2017 Feb 9.

  PMID: 28222970 RESULT

MeSH Terms

Conditions

Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases

Central Study Contacts

Yongshun Chen, MD

CONTACT

+86 15327122084; yongshun2007@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: June 1, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)