NCT06565858

Brief Summary

The aim of this study is to evaluate the role/impact of physical activity (PA) in sarcomas, in their distribution and potentially also on their prognosis, as already demonstrated for other neoplasms. Type, intensity, frequency, duration and circumstance of both occupational and leisure physical activity will be collected through validated questionnaires and self-reported measurement methods.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
3mo left

Started Sep 2024

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 Progress84%
Sep 2024Aug 2026

First Submitted

Initial submission to the registry

August 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

September 20, 2024

Status Verified

August 1, 2024

Enrollment Period

11 months

First QC Date

August 20, 2024

Last Update Submit

September 19, 2024

Conditions

Keywords

SarcomaPhysical activity

Outcome Measures

Primary Outcomes (1)

  • Prevalence PA

    The prevalence of physical activity (PA) in patients with sarcoma

    12 months

Eligibility Criteria

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

This is a prospective observational study recruiting patients diagnosed with sarcomas any site. Since sarcoma develop in bone, soft tissue and viscera, sarcoma appear suitable to investigate the role of physical activity on sarcoma in different locations.

You may qualify if:

  • age \>18;
  • diagnose of sarcoma;
  • Written informed consent must be signed and dated by the patient and the investigator.

You may not qualify if:

  • Kaposi sarcoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Related Publications (8)

  • Meyerhardt JA, Heseltine D, Niedzwiecki D, Hollis D, Saltz LB, Mayer RJ, Thomas J, Nelson H, Whittom R, Hantel A, Schilsky RL, Fuchs CS. Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol. 2006 Aug 1;24(22):3535-41. doi: 10.1200/JCO.2006.06.0863. Epub 2006 Jul 5.

    PMID: 16822843BACKGROUND
  • McTiernan A, Friedenreich CM, Katzmarzyk PT, Powell KE, Macko R, Buchner D, Pescatello LS, Bloodgood B, Tennant B, Vaux-Bjerke A, George SM, Troiano RP, Piercy KL; 2018 PHYSICAL ACTIVITY GUIDELINES ADVISORY COMMITTEE*. Physical Activity in Cancer Prevention and Survival: A Systematic Review. Med Sci Sports Exerc. 2019 Jun;51(6):1252-1261. doi: 10.1249/MSS.0000000000001937.

  • Matthews CE, Moore SC, Arem H, Cook MB, Trabert B, Hakansson N, Larsson SC, Wolk A, Gapstur SM, Lynch BM, Milne RL, Freedman ND, Huang WY, Berrington de Gonzalez A, Kitahara CM, Linet MS, Shiroma EJ, Sandin S, Patel AV, Lee IM. Amount and Intensity of Leisure-Time Physical Activity and Lower Cancer Risk. J Clin Oncol. 2020 Mar 1;38(7):686-697. doi: 10.1200/JCO.19.02407. Epub 2019 Dec 26.

  • Moore SC, Lee IM, Weiderpass E, Campbell PT, Sampson JN, Kitahara CM, Keadle SK, Arem H, Berrington de Gonzalez A, Hartge P, Adami HO, Blair CK, Borch KB, Boyd E, Check DP, Fournier A, Freedman ND, Gunter M, Johannson M, Khaw KT, Linet MS, Orsini N, Park Y, Riboli E, Robien K, Schairer C, Sesso H, Spriggs M, Van Dusen R, Wolk A, Matthews CE, Patel AV. Association of Leisure-Time Physical Activity With Risk of 26 Types of Cancer in 1.44 Million Adults. JAMA Intern Med. 2016 Jun 1;176(6):816-25. doi: 10.1001/jamainternmed.2016.1548.

  • McTiernan A. Mechanisms linking physical activity with cancer. Nat Rev Cancer. 2008 Mar;8(3):205-11. doi: 10.1038/nrc2325.

  • Ibrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22.

  • Meyerhardt JA, Giovannucci EL, Ogino S, Kirkner GJ, Chan AT, Willett W, Fuchs CS. Physical activity and male colorectal cancer survival. Arch Intern Med. 2009 Dec 14;169(22):2102-8. doi: 10.1001/archinternmed.2009.412.

  • Meyerhardt JA, Giovannucci EL, Holmes MD, Chan AT, Chan JA, Colditz GA, Fuchs CS. Physical activity and survival after colorectal cancer diagnosis. J Clin Oncol. 2006 Aug 1;24(22):3527-34. doi: 10.1200/JCO.2006.06.0855. Epub 2006 Jul 5.

MeSH Terms

Conditions

SarcomaMotor Activity

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsBehavior

Study Officials

  • Paola Queirolo, MD

    Istituto Europeo di Oncologia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paola Queirolo, MD

CONTACT

Maristella Saponara, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2024

First Posted

August 22, 2024

Study Start

September 30, 2024

Primary Completion

August 30, 2025

Study Completion (Estimated)

August 30, 2026

Last Updated

September 20, 2024

Record last verified: 2024-08

Locations