Effect of Sarcopenia on Hepatocellular Carcinoma(HCC) After Systemic Therapies

NCT05448222 | Unknown

• 1 other identifier: sarcopenia and liver cancer
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is associated with the prognosis of HCC and cholangiocarcinoma. But there has been rare study focusing on the effect of sarcopenia on the prognosis of HCC treated with systemic therapy, such as interventional therapy, targeted therapy, chemotherapy and immunotherapy and so on.

Conditions

Hepatocellular Carcinoma; Sarcopenia

Keywords

hepatocellular carcinoma; sarcopenia; prognosis; adverse events; systemic therapy

Outcome Measures

Primary Outcomes (3)

• complications

  The complications were classified according to the Clavien-Dindo classification, such as hypertension, fever, abdominal pain and so on.

  3 months

• overall survival

  Overall survival was defined as the time from initiation of lenvatinib to death for any reason.

  2 years

• progression free survival

  Progression free survival was defined as the time from initiation of lenvatinib to first progression or death.

  2 years

Secondary Outcomes (2)

• Hospital stay

  3 months

• Hospital cost

  3 months

Interventions

Diagnostic Test: gait speed; ct scan; grip strength and chair stand test DIAGNOSTIC_TEST

The chair stand test was administered, and the time required for the patient to stand five times from a sitting position without using the arms was measured. CT scan was to scan the patient's third lumbar level. For the gait speed test, the time that patients spent walking 8 meters on a flat indoor floor at usual walking speed was measured.Grip strength test:the dominant hand and the nondominant hand were measured twice intermittently (kg), and the average value of 4 values was obtained.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical diagnosis of hepatocellular carcinoma admitted to the first affiliated hospital of wenzhou medical university and received standard tests and questionnaires.

You may qualify if:

• clinical diagnosis of hepatocellular carcinoma
• No cancer other than liver cancer has been diagnosed
• Age ≥18 years
• child-pugh score≤7

You may not qualify if:

• uncompleted standard tests and questionnaires
• received other therapies
• Patients who had other causes of muscle weakness (injury, fracture, stroke, etc.)
• Patients who missing CT data or CT scan did not reach the level of the third lumbar vertebra (L3)
• lost follow-up

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator
• Eastern Hepatobiliary Surgery Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Sites (1)

Gang Chen

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (5)

• Smith C, Woessner MN, Sim M, Levinger I. Sarcopenia definition: Does it really matter? Implications for resistance training. Ageing Res Rev. 2022 Jun;78:101617. doi: 10.1016/j.arr.2022.101617. Epub 2022 Apr 1.

  PMID: 35378297 BACKGROUND

• Leong DP, Teo KK, Rangarajan S, Lopez-Jaramillo P, Avezum A Jr, Orlandini A, Seron P, Ahmed SH, Rosengren A, Kelishadi R, Rahman O, Swaminathan S, Iqbal R, Gupta R, Lear SA, Oguz A, Yusoff K, Zatonska K, Chifamba J, Igumbor E, Mohan V, Anjana RM, Gu H, Li W, Yusuf S; Prospective Urban Rural Epidemiology (PURE) Study investigators. Prognostic value of grip strength: findings from the Prospective Urban Rural Epidemiology (PURE) study. Lancet. 2015 Jul 18;386(9990):266-73. doi: 10.1016/S0140-6736(14)62000-6. Epub 2015 May 13.

  PMID: 25982160 BACKGROUND

• Chen LK, Woo J, Assantachai P, Auyeung TW, Chou MY, Iijima K, Jang HC, Kang L, Kim M, Kim S, Kojima T, Kuzuya M, Lee JSW, Lee SY, Lee WJ, Lee Y, Liang CK, Lim JY, Lim WS, Peng LN, Sugimoto K, Tanaka T, Won CW, Yamada M, Zhang T, Akishita M, Arai H. Asian Working Group for Sarcopenia: 2019 Consensus Update on Sarcopenia Diagnosis and Treatment. J Am Med Dir Assoc. 2020 Mar;21(3):300-307.e2. doi: 10.1016/j.jamda.2019.12.012. Epub 2020 Feb 4.

  PMID: 32033882 BACKGROUND

• Kobayashi A, Kaido T, Hamaguchi Y, Okumura S, Shirai H, Yao S, Kamo N, Yagi S, Taura K, Okajima H, Uemoto S. Impact of Sarcopenic Obesity on Outcomes in Patients Undergoing Hepatectomy for Hepatocellular Carcinoma. Ann Surg. 2019 May;269(5):924-931. doi: 10.1097/SLA.0000000000002555.

  PMID: 29064889 BACKGROUND

• Dasarathy S, Merli M. Sarcopenia from mechanism to diagnosis and treatment in liver disease. J Hepatol. 2016 Dec;65(6):1232-1244. doi: 10.1016/j.jhep.2016.07.040. Epub 2016 Aug 8.

  PMID: 27515775 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Sarcopenia

Interventions

Tomography, X-Ray Computed; Hand Strength

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Muscle Strength; Physical Examination; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Principal Investigator

Study Record Dates

• First Submitted: July 1, 2022
• First Posted: July 7, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)