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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (12)

• Frequency of Participants with Hand Grip Strength (HGS) Measurements at Study Baseline [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Канада · 1 центр

• BC Cancer — Vancouver

Публикации

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• 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
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• 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

Идентификаторы

NCT: NCT07255001 · H25-00754

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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