Using Strength Tests to Better Understand How Pancreatic Cancer Affects Muscle Mass and Quality of Life

Official title

Monitoring Physical Function Changes in Patients With Pancreatic Ductal Adenocarcinoma: Potential for Better Understanding of Treatment Trajectory and Survival

Overview

The goal of this clinical trial is to measure hand grip strength in adults with pancreatic ductal adenocarcinoma (PDAC). The main questions it aims to answer are: * Is it feasible to measure hand grip strength as part of a clinic visit? * Are changes in hand grip strength related to changes in body composition? * Is hand grip strength related to a person's well-being? * Is hand grip strength related to how a tumour responds to treatment? Participants will squeeze a device with their hand to measure their hand grip strength and complete questionnaires about their well-being when they are seen in clinic for their regular medical care for PDAC.

Interventions

• Device Hand grip strength assessments using a dynamometer
  Squeeze a dynamometer with one hand to measure hand grip strength.

Primary outcome measures

• Frequency of Participants with Hand Grip Strength (HGS) Measurements at 6 Months From Treatment Start Date [Time frame: From the date anti-cancer therapy is initiated until the 6-month follow-up assessment.]

Secondary outcome measures (12)

• Frequency of Participants with Hand Grip Strength (HGS) Measurements at Study Baseline [Time frame: At the time of the baseline assessment for the study.]
• Frequency of Participants with Hand Grip Strength (HGS) Measurements at 3 Months From Treatment Start Date [Time frame: From the date anti-cancer therapy is initiated until the 3-month follow-up assessment.]
• Frequency of Participants with Hand Grip Strength (HGS) Measurements at 9 Months From Treatment Start Date [Time frame: From the date anti-cancer therapy is initiated until the 9-month follow-up assessment.]
• Frequency of Participants with Hand Grip Strength (HGS) Measurements at 12 Months From Treatment Start Date [Time frame: From the date anti-cancer therapy is initiated until the 12-month follow-up assessment.]
• Proportion of Participants with Sarcopenia Using CT Image Alone (Sarcopenia CT) [Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.]
• Proportion of Participants with Sarcopenia Using Physical Function Alone (Sarcopenia P) [Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.]
• Proportion of Participants with Sarcopenia Using a Combination of CT Image and Physical Function (Sarcopenia COMB) [Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.]
• Strength and Direction of the Relationship Between Hand Grip Strength (HGS) and Skeletal Muscle Index (SMI) [Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.]
• Strength and Direction of the Relationship Between Hand Grip Strength (HGS) and Skeletal Muscle Density (SMD) [Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.]
• Strength and Direction of the Relationship Between Hand Grip Strength (HGS) and Skeletal Muscle Gauge (SMG) [Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.]
• Strength and Direction of the Relationship Between Hand Grip Strength (HGS) and Visceral Adipose Tissue (VAT) [Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.]
• Strength and Direction of the Relationship Between Hand Grip Strength (HGS) and Subcutaneous Adipose Tissue (SAT) [Time frame: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.]

Eligibility criteria

Inclusion criteria

• Age 18 years or older.
• Histological and/or radiological diagnosis of resectable, non-resectable, or metastatic PDAC. For resectable PDAC, adjuvant setting only.
• ECOG performance status 0-2.
• Life expectancy greater than 6 months as judged by the investigator.
• Planned for treatment, either as part of routine care or in combination with an investigational agent within another study.
• Ability to hold a dynamometer with one hand.

Exclusion criteria

• Individuals with CT imaging performed outside of Vancouver, BC, Canada.
• Individuals who are unfit to undergo CT imaging of the third lumbar vertebra (L3).
• Individuals who are currently participating in a structured moderate intensity resistance training program.
• Individuals who are otherwise judged by the investigator to be unfit to proceed with this protocol.
• Unable to comply with study assessments and follow-up.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Basic science

Study locations

Canada · 1 center

• BC Cancer — Vancouver

Publications

• Armstrong V, Stretch C, Fitzgerald L, Gopaul A, McKinnon G, Koziak J, Kopciuk K, Brockton N, Bathe O. Characterizing cancer-associated myosteatosis: anatomic distribution and cancer-specific variability of low radiodensity muscle. JCSM Rapid Communications. 2021; 4(2):197-206. doi: 10.1002/rco2.46
• Song M, Zhang Q, Tang M, Zhang X, Ruan G, Zhang X, Zhang K, Ge Y, Yang M, Li Q, Li X, Liu X, Li W, Cong M, Wang K, Song C, Shi H. Associations of low hand grip strength with 1 year mortality of cancer cachexia: a multicentre observational study. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1489-1500. doi: 10.1002/jcsm.12778. Epub 2021 Sep 20. PMID 34545711
• Cheville A. Rehabilitation of patients with advanced cancer. Cancer. 2001 Aug 15;92(4 Suppl):1039-48. doi: 10.1002/1097-0142(20010815)92:4+3.0.co;2-l. PMID 11519031
• Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. PMID 8433390
• Wheelwright S, Darlington AS, Hopkinson JB, Fitzsimmons D, White A, Johnson CD. A systematic review of health-related quality of life instruments in patients with cancer cachexia. Support Care Cancer. 2013 Sep;21(9):2625-36. doi: 10.1007/s00520-013-1881-9. Epub 2013 Jun 25. PMID 23797577
• Cella D, Stone AA. Health-related quality of life measurement in oncology: advances and opportunities. Am Psychol. 2015 Feb-Mar;70(2):175-85. doi: 10.1037/a0037821. PMID 25730723
• Hagens ERC, Feenstra ML, van Egmond MA, van Laarhoven HWM, Hulshof MCCM, Boshier PR, Low DE, van Berge Henegouwen MI, Gisbertz SS. Influence of body composition and muscle strength on outcomes after multimodal oesophageal cancer treatment. J Cachexia Sarcopenia Muscle. 2020 Jun;11(3):756-767. doi: 10.1002/jcsm.12540. Epub 2020 Feb 25. PMID 32096923
• Caan BJ, Meyerhardt JA, Kroenke CH, Alexeeff S, Xiao J, Weltzien E, Feliciano EC, Castillo AL, Quesenberry CP, Kwan ML, Prado CM. Explaining the Obesity Paradox: The Association between Body Composition and Colorectal Cancer Survival (C-SCANS Study). Cancer Epidemiol Biomarkers Prev. 2017 Jul;26(7):1008-1015. doi: 10.1158/1055-9965.EPI-17-0200. Epub 2017 May 15. PMID 28506965

Identifiers

NCT: NCT07255001 · H25-00754

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗