NCT07255001

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress21%
Dec 2025Dec 2027

First Submitted

Initial submission to the registry

September 2, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 28, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

November 28, 2025

Status Verified

November 1, 2025

Enrollment Period

2.1 years

First QC Date

September 2, 2025

Last Update Submit

November 25, 2025

Conditions

Keywords

Pancreatic ductal adenocarcinoma (PDAC)Hand grip strength (HGS)Quality of Life (QOL)Body compositionCachexiaSarcopeniaPhysical functionSkeletal muscleAdipose tissue

Outcome Measures

Primary Outcomes (1)

  • Frequency of Participants with Hand Grip Strength (HGS) Measurements at 6 Months From Treatment Start Date

    The percentage of participants with hand grip strength (HGS) test results at 6 months from treatment start date. Hand grip strength is measured in kilograms with a hand-held dynamometer.

    From the date anti-cancer therapy is initiated until the 6-month follow-up assessment.

Secondary Outcomes (202)

  • Frequency of Participants with Hand Grip Strength (HGS) Measurements at Study Baseline

    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

    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

    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

    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)

    From the date anti-cancer therapy is initiated until the follow-up assessments at 3, 6, 9, and 12 months.

  • +197 more secondary outcomes

Study Arms (1)

Main Study Arm

EXPERIMENTAL

The study arm all participants are enrolled into. Participants will complete hand grip strength assessments and questionnaires.

Device: Hand grip strength assessments using a dynamometer

Interventions

Squeeze a dynamometer with one hand to measure hand grip strength.

Main Study Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Cancer

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Related Publications (35)

  • 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

    BACKGROUND
  • 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: 34545711BACKGROUND
  • 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: 11519031BACKGROUND
  • 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: 8433390BACKGROUND
  • 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: 23797577BACKGROUND
  • 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: 25730723BACKGROUND
  • 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: 32096923BACKGROUND
  • 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: 28506965BACKGROUND
  • Malietzis G, Aziz O, Bagnall NM, Johns N, Fearon KC, Jenkins JT. The role of body composition evaluation by computerized tomography in determining colorectal cancer treatment outcomes: a systematic review. Eur J Surg Oncol. 2015 Feb;41(2):186-96. doi: 10.1016/j.ejso.2014.10.056. Epub 2014 Nov 3.

    PMID: 25468746BACKGROUND
  • Correa-de-Araujo R, Addison O, Miljkovic I, Goodpaster BH, Bergman BC, Clark RV, Elena JW, Esser KA, Ferrucci L, Harris-Love MO, Kritchevsky SB, Lorbergs A, Shepherd JA, Shulman GI, Rosen CJ. Myosteatosis in the Context of Skeletal Muscle Function Deficit: An Interdisciplinary Workshop at the National Institute on Aging. Front Physiol. 2020 Aug 7;11:963. doi: 10.3389/fphys.2020.00963. eCollection 2020.

    PMID: 32903666BACKGROUND
  • Aleixo GFP, Shachar SS, Nyrop KA, Muss HB, Malpica L, Williams GR. Myosteatosis and prognosis in cancer: Systematic review and meta-analysis. Crit Rev Oncol Hematol. 2020 Jan;145:102839. doi: 10.1016/j.critrevonc.2019.102839. Epub 2019 Dec 20.

    PMID: 31877534BACKGROUND
  • Mourtzakis M, Prado CM, Lieffers JR, Reiman T, McCargar LJ, Baracos VE. A practical and precise approach to quantification of body composition in cancer patients using computed tomography images acquired during routine care. Appl Physiol Nutr Metab. 2008 Oct;33(5):997-1006. doi: 10.1139/H08-075.

    PMID: 18923576BACKGROUND
  • Alipour S, Kennecke HF, Woods R, Lim HJ, Speers C, Brown CJ, Gill S, Renouf DJ, Cheung WY. Body mass index and body surface area and their associations with outcomes in stage II and III colon cancer. J Gastrointest Cancer. 2013 Jun;44(2):203-10. doi: 10.1007/s12029-012-9472-4.

    PMID: 23264206BACKGROUND
  • Zanker J, Sim M, Anderson K, Balogun S, Brennan-Olsen SL, Dent E, Duque G, Girgis CM, Grossmann M, Hayes A, Henwood T, Hirani V, Inderjeeth C, Iuliano S, Keogh J, Lewis JR, Lynch GS, Pasco JA, Phu S, Reijnierse EM, Russell N, Vlietstra L, Visvanathan R, Walker T, Waters DL, Yu S, Maier AB, Daly RM, Scott D. Consensus guidelines for sarcopenia prevention, diagnosis and management in Australia and New Zealand. J Cachexia Sarcopenia Muscle. 2023 Feb;14(1):142-156. doi: 10.1002/jcsm.13115. Epub 2022 Nov 9.

    PMID: 36349684BACKGROUND
  • Cao A, Ferrucci LM, Caan BJ, Irwin ML. Effect of Exercise on Sarcopenia among Cancer Survivors: A Systematic Review. Cancers (Basel). 2022 Feb 3;14(3):786. doi: 10.3390/cancers14030786.

    PMID: 35159052BACKGROUND
  • Zanker J, Sim M, Anderson K, Balogun S, Brennan-Olsen SL, Dent E, Duque G, Girgis CM, Grossmann M, Hayes A, Henwood T, Hirani V, Inderjeeth C, Iuliano S, Keogh J, Lewis JR, Lynch GS, Pasco JA, Phu S, Reijnierse EM, Russell N, Vlietstra L, Visvanathan R, Walker T, Waters DL, Yu S, Maier AB, Daly RM, Scott D. The Australian and New Zealand Society for Sarcopenia and Frailty Research (ANZSSFR) sarcopenia diagnosis and management task force: Findings from the consumer expert Delphi process. Australas J Ageing. 2023 Mar;42(1):251-257. doi: 10.1111/ajag.13164. Epub 2022 Dec 8.

    PMID: 36480154BACKGROUND
  • 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: 32033882BACKGROUND
  • Bhasin S, Travison TG, Manini TM, Patel S, Pencina KM, Fielding RA, Magaziner JM, Newman AB, Kiel DP, Cooper C, Guralnik JM, Cauley JA, Arai H, Clark BC, Landi F, Schaap LA, Pereira SL, Rooks D, Woo J, Woodhouse LJ, Binder E, Brown T, Shardell M, Xue QL, D'Agostino RB Sr, Orwig D, Gorsicki G, Correa-De-Araujo R, Cawthon PM. Sarcopenia Definition: The Position Statements of the Sarcopenia Definition and Outcomes Consortium. J Am Geriatr Soc. 2020 Jul;68(7):1410-1418. doi: 10.1111/jgs.16372. Epub 2020 Mar 9.

    PMID: 32150289BACKGROUND
  • Groarke JD, Crawford J, Collins SM, Lubaczewski S, Roeland EJ, Naito T, Hendifar AE, Fallon M, Takayama K, Asmis T, Dunne RF, Karahanoglu I, Northcott CA, Harrington MA, Rossulek M, Qiu R, Saxena AR. Ponsegromab for the Treatment of Cancer Cachexia. N Engl J Med. 2024 Dec 19;391(24):2291-2303. doi: 10.1056/NEJMoa2409515. Epub 2024 Sep 14.

    PMID: 39282907BACKGROUND
  • Dolly A, Dumas JF, Servais S. Cancer cachexia and skeletal muscle atrophy in clinical studies: what do we really know? J Cachexia Sarcopenia Muscle. 2020 Dec;11(6):1413-1428. doi: 10.1002/jcsm.12633. Epub 2020 Oct 14.

    PMID: 33053604BACKGROUND
  • Tisdale MJ. Molecular pathways leading to cancer cachexia. Physiology (Bethesda). 2005 Oct;20:340-8. doi: 10.1152/physiol.00019.2005.

    PMID: 16174873BACKGROUND
  • 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
  • Vanhoutte G, van de Wiel M, Wouters K, Sels M, Bartolomeeussen L, De Keersmaecker S, Verschueren C, De Vroey V, De Wilde A, Smits E, Cheung KJ, De Clerck L, Aerts P, Baert D, Vandoninck C, Kindt S, Schelfhaut S, Vankerkhoven M, Troch A, Ceulemans L, Vandenbergh H, Leys S, Rondou T, Dewitte E, Maes K, Pauwels P, De Winter B, Van Gaal L, Ysebaert D, Peeters M. Cachexia in cancer: what is in the definition? BMJ Open Gastroenterol. 2016 Oct 18;3(1):e000097. doi: 10.1136/bmjgast-2016-000097. eCollection 2016.

    PMID: 27843571BACKGROUND
  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

    PMID: 30312372BACKGROUND
  • Westbury LD, Beaudart C, Bruyere O, Cauley JA, Cawthon P, Cruz-Jentoft AJ, Curtis EM, Ensrud K, Fielding RA, Johansson H, Kanis JA, Karlsson MK, Lane NE, Lengele L, Lorentzon M, McCloskey E, Mellstrom D, Newman AB, Ohlsson C, Orwoll E, Reginster JY, Ribom E, Rosengren BE, Schousboe JT, Shiroma EJ, Harvey NC, Dennison EM, Cooper C; International Musculoskeletal Ageing Network. Recent sarcopenia definitions-prevalence, agreement and mortality associations among men: Findings from population-based cohorts. J Cachexia Sarcopenia Muscle. 2023 Feb;14(1):565-575. doi: 10.1002/jcsm.13160. Epub 2023 Jan 5.

    PMID: 36604970BACKGROUND
  • Mueller TC, Burmeister MA, Bachmann J, Martignoni ME. Cachexia and pancreatic cancer: are there treatment options? World J Gastroenterol. 2014 Jul 28;20(28):9361-73. doi: 10.3748/wjg.v20.i28.9361.

    PMID: 25071331BACKGROUND
  • Brown JC, Caan BJ, Prado CM, Cespedes Feliciano EM, Xiao J, Kroenke CH, Meyerhardt JA. The Association of Abdominal Adiposity With Mortality in Patients With Stage I-III Colorectal Cancer. J Natl Cancer Inst. 2020 Apr 1;112(4):377-383. doi: 10.1093/jnci/djz150.

    PMID: 31355882BACKGROUND
  • Cespedes Feliciano EM, Lee VS, Prado CM, Meyerhardt JA, Alexeeff S, Kroenke CH, Xiao J, Castillo AL, Caan BJ. Muscle mass at the time of diagnosis of nonmetastatic colon cancer and early discontinuation of chemotherapy, delays, and dose reductions on adjuvant FOLFOX: The C-SCANS study. Cancer. 2017 Dec 15;123(24):4868-4877. doi: 10.1002/cncr.30950. Epub 2017 Sep 7.

    PMID: 28881381BACKGROUND
  • Ali R, Baracos VE, Sawyer MB, Bianchi L, Roberts S, Assenat E, Mollevi C, Senesse P. Lean body mass as an independent determinant of dose-limiting toxicity and neuropathy in patients with colon cancer treated with FOLFOX regimens. Cancer Med. 2016 Apr;5(4):607-16. doi: 10.1002/cam4.621. Epub 2016 Jan 27.

    PMID: 26814378BACKGROUND
  • Jung HW, Kim JW, Kim JY, Kim SW, Yang HK, Lee JW, Lee KW, Kim DW, Kang SB, Kim KI, Kim CH, Kim JH. Effect of muscle mass on toxicity and survival in patients with colon cancer undergoing adjuvant chemotherapy. Support Care Cancer. 2015 Mar;23(3):687-94. doi: 10.1007/s00520-014-2418-6. Epub 2014 Aug 28.

    PMID: 25163434BACKGROUND
  • Yip C, Dinkel C, Mahajan A, Siddique M, Cook GJ, Goh V. Imaging body composition in cancer patients: visceral obesity, sarcopenia and sarcopenic obesity may impact on clinical outcome. Insights Imaging. 2015 Aug;6(4):489-97. doi: 10.1007/s13244-015-0414-0. Epub 2015 Jun 13.

    PMID: 26070723BACKGROUND
  • Antoun S, Borget I, Lanoy E. Impact of sarcopenia on the prognosis and treatment toxicities in patients diagnosed with cancer. Curr Opin Support Palliat Care. 2013 Dec;7(4):383-9. doi: 10.1097/SPC.0000000000000011.

    PMID: 24189893BACKGROUND
  • Prado CM, Baracos VE, McCargar LJ, Mourtzakis M, Mulder KE, Reiman T, Butts CA, Scarfe AG, Sawyer MB. Body composition as an independent determinant of 5-fluorouracil-based chemotherapy toxicity. Clin Cancer Res. 2007 Jun 1;13(11):3264-8. doi: 10.1158/1078-0432.CCR-06-3067.

    PMID: 17545532BACKGROUND
  • Ngo-Huang AT, Parker NH, Xiao L, Schadler KL, Petzel MQB, Prakash LR, Kim MP, Tzeng CD, Lee JE, Ikoma N, Wolff RA, Javle MM, Koay EJ, Pant SD, Folloder JP, Wang X, Cotto AM, Ju YR, Garg N, Wang H, Bruera ED, Basen-Engquist KM, Katz MHG. Effects of a Pragmatic Home-based Exercise Program Concurrent With Neoadjuvant Therapy on Physical Function of Patients With Pancreatic Cancer: The PancFit Randomized Clinical Trial. Ann Surg. 2023 Jul 1;278(1):22-30. doi: 10.1097/SLA.0000000000005878. Epub 2023 Apr 7.

    PMID: 37026453BACKGROUND
  • Lew D, Kamal F, Phan K, Randhawa K, Cornwell S, Bangolo AI, Weissman S, Pandol SJ. Epidemiologic risk factors for patients admitted with chronic pancreatitis and pancreatic ductal adenocarcinoma in the United States. World J Clin Oncol. 2022 Nov 24;13(11):907-917. doi: 10.5306/wjco.v13.i11.907.

    PMID: 36483975BACKGROUND

MeSH Terms

Conditions

CachexiaSarcopenia

Condition Hierarchy (Ancestors)

Weight LossBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsThinnessMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, Anatomical

Central Study Contacts

Daniel J Renouf, MD, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2025

First Posted

November 28, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

November 28, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Only aggregate data will be shared with other researchers.

Locations