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Digestive System CancerNCT06223230

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

A study testing Nutritional psychological interventions and vomit-free management in people with Digestive System Cancer and Digestive System Neoplasm, run by Renmin Hospital of Wuhan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Nutritional psychological interventions and vomit-free management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
1 siteChina
Study dates
1 Jun 2022to 30 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • patients who, in the judgment of the investigator, are not suitable for inclusion in this study.

Trial locations and contacts

1 site in 1 country.

Yongshun Chen, MD contact

+86 15327122084

yongshun2007@163.com

China1 site, 1 recruiting

  • Renmin hosptial of Wuhan University

    Wuhan, Hubei, 430060

    Liwei Chen, 86+15671578311, wdrmiit@163.com

    Recruiting

Other trials in China

About this study

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

Being tested
Nutritional psychological interventions and vomit-free management
Medical subject headings
Digestive System Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional psychological interventions and vomit-free managementOther

    Nutritional psychological interventions and vomit-free management

Study groups in NCT06223230
Study groupRoleWhat they receive
Study groupExperimentalFirst-line treatment received standard antitumor therapy and nutritional psychological interventions with and without vomit management
Receives: Other: Nutritional psychological interventions and vomit-free management
Control groupNo interventionFirst-line treatment receives standard antitumor therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 40 months from date of the first participant randomization

Secondary outcomes (6)

  1. completion rate

    The treatment completion rate is defined as the ratio of the number of patients actually completing the established intensity or number of cycles of treatment for subjects enrolled in the study to the total number of patients scheduled to complete the established intensity or number of cycles of treatment during the same period, in accordance with the conventional antineoplastic treatment schedule

    Measured: Approximately 40 months from date of the first participant randomization

  2. Quality of Life(QoL)

    Survival quality was compared by the Karnofsky Performance Status (KPS)score, a Karnofsky functional status rating scale.

    Measured: Approximately 40 months from date of the first participant randomization

  3. median Overall Survival

    Overall survival(OS) is defined as the period from the date of treatment to the date of death from any cause. The OS of patients who were alive at the last follow-up visit was counted as data censored at the time of the last follow-up visit. For patients who were lost to follow-up, their OS was data censored at the time of last confirmed survival prior to loss to follow-up. Median overall survival, which is the survival time corresponding to when the cumulative survival rate is 0.5, indicates that 50% of individuals will live beyond this time.

    Measured: Approximately 40 months from date of the first participant randomization

  4. Disease Control Rate

    Refers to the proportion of patients whose tumors shrink or are stable and remain so for a certain period of time, and includes cases of CR, PR and SD. Subjects had to be accompanied by a measurable tumor lesion at baseline, and the efficacy rating criteria were classified as complete remission (CR), partial remission (PR), stable disease (SD), and disease progression (PD) according to RECIST v1.1.

    Measured: Approximately 40 months from date of the first participant randomization

  5. Objective Response Rate

    Refers to the proportion of patients whose tumors have shrunk to a certain level and remained there for a certain period of time, and includes both CR and PR cases.

    Measured: Approximately 40 months from date of the first participant randomization

  6. Duration of Response

    Refers to the time from the first time the tumor was assessed as CR or PR (whichever was measured first) to the time of the first true recording of PD (using the smallest measurement recorded in the trial as a reference for disease progression).

    Measured: Approximately 40 months from date of the first participant randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start1 Jun 2022
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06223230
Sponsor's protocol ID
WDRY2022-K092
Status last verified
Jan 2024
First submitted
16 Jan 2024
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30207593

  • 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.

    PubMed 26808342

  • 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.

    PubMed 23354431

  • 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.

    PubMed 28017447

  • 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.

    PubMed 16601440

  • 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.

    PubMed 20719409

  • 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.

    PubMed 22222249

  • 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.

    PubMed 22072493

  • 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.

    PubMed 27582634

  • 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.

    PubMed 26626800

  • 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.

    PubMed 28222970

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional psychological interventions and vomit-free management in people with Digestive System Cancer and Digestive System Neoplasm, run by Renmin Hospital of Wuhan University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongshun Chen, MD (+86 15327122084, yongshun2007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median progression-free survival time (time frame: Approximately 40 months from date of the first participant randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06223230, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.

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