NCT05103059

Brief Summary

Serum albumin can indicate the onset of cancer cachexia, provide information about a patient's nutritional status, and serve as a biomarker for the prognosis of patients with cancer cachexia. However, the relationship between serum albumin levels and mortality in patients with cancer cachexia remains unclear. We aimed to examine the association of albumin and total protein with 1-year mortality in patients with cancer cachexia

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

October 21, 2021

Last Update Submit

October 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • the association between serum albumin and total protein with one year mortality in patients with cancer cachexia

    to evaluate the association between serum albumin and total protein with one year mortality in patients with cancr cachexia

    baseline

Secondary Outcomes (1)

  • the association between anthropometric measures and other laboratory findings with one year mortality in patients with cancer cachexia

    baseline

Interventions

BMIDIAGNOSTIC_TEST

Patients with cancer cachexia will be enrolled in the study, and the following data will be collected: age, sex, total protein, albumin, hemoglobin (Hb), white blood cell (WBC) count, neutrophil count, lymphocyte count, red blood cell (RBC) count, platelet (PLT) count, body mass index (BMI), mid-arm circumference (MAC), thickness of triceps skinfold (TSF), handgrip strength (HGS), and calf circumference (CC)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

weight loss in the past 12 months is ≥5%, and the physiological variables of patients match at least threeof the following five criteria: decreased muscle strength,fatigue, anorexia, low fat-free mass index (FFMI), and abnormal blood profile

You may qualify if:

  • patients who will accept to participate in our study with diagnosis of cancer cachexia

You may not qualify if:

  • patients who not fulfill criteria of cance cachexia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.

    PMID: 21296615BACKGROUND
  • Schmidt SF, Rohm M, Herzig S, Berriel Diaz M. Cancer Cachexia: More Than Skeletal Muscle Wasting. Trends Cancer. 2018 Dec;4(12):849-860. doi: 10.1016/j.trecan.2018.10.001. Epub 2018 Oct 24.

    PMID: 30470306BACKGROUND
  • Evans WJ, Morley JE, Argiles J, Bales C, Baracos V, Guttridge D, Jatoi A, Kalantar-Zadeh K, Lochs H, Mantovani G, Marks D, Mitch WE, Muscaritoli M, Najand A, Ponikowski P, Rossi Fanelli F, Schambelan M, Schols A, Schuster M, Thomas D, Wolfe R, Anker SD. Cachexia: a new definition. Clin Nutr. 2008 Dec;27(6):793-9. doi: 10.1016/j.clnu.2008.06.013. Epub 2008 Aug 21.

    PMID: 18718696BACKGROUND
  • Penet MF, Bhujwalla ZM. Cancer cachexia, recent advances, and future directions. Cancer J. 2015 Mar-Apr;21(2):117-22. doi: 10.1097/PPO.0000000000000100.

    PMID: 25815852BACKGROUND
  • Cong M, Song C, Xu H, Song C, Wang C, Fu Z, Ba Y, Wu J, Xie C, Chen G, Chen Z, Zhou L, Li T, Deng L, Xin L, Yang L, Cui J, Shi H; Investigation on Nutrition Status and Clinical Outcome of Common Cancers (INSCOC) Group. The patient-generated subjective global assessment is a promising screening tool for cancer cachexia. BMJ Support Palliat Care. 2022 May;12(e1):e39-e46. doi: 10.1136/bmjspcare-2020-002296. Epub 2020 Aug 21.

    PMID: 32826265BACKGROUND
  • Matsuzuka T, Kiyota N, Mizusawa J, Akimoto T, Fujii M, Hasegawa Y, Iwae S, Monden N, Matsuura K, Onozawa Y, Hayashi R, Tahara M; Japan Clinical Oncology Group(JCOG) Head and Neck Cancer Study Group. Clinical impact of cachexia in unresectable locally advanced head and neck cancer: supplementary analysis of a phase II trial (JCOG0706-S2). Jpn J Clin Oncol. 2019 Jan 1;49(1):37-41. doi: 10.1093/jjco/hyy145.

    PMID: 30364985BACKGROUND

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

nehal suliman, resident doctor

CONTACT

samir shehata, professor doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prognostic value of serum albumin and total protein in survival of cancer cachectic patients

Study Record Dates

First Submitted

October 21, 2021

First Posted

November 2, 2021

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

December 1, 2022

Last Updated

November 2, 2021

Record last verified: 2021-10