Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT04983199

Conditions

Metastatic Cancer

Palliative

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hexoskin Medical System

Study Details

Brief summary:

This is an observational study to investigate if it is feasible to recruit 100 patients receiving radiotherapy (RT) to metastatic disease to wear Hexoskin and if Hexoskin will facilitate the monitoring, detection and early treatment of RT-related side effects.

Conditions

Metastatic Cancer

Palliative

Study ID

NCT04983199

Start date

Nov 24, 2022

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Planned to receive palliative radiotherapy for pain
  • Known cancer diagnosis
  • Able to wear Hexoskin Medical Shirt
  • Ability to use and populate the mobile app (Zamplo) with or without assistance
  • ECOG: 0-3
  • Willing to provide a list of analgesic (pain relief) medication
  • Willing to complete questionnaires
  • Life expectancy of at least 3 months

Exclusion Criteria:

  • Receiving whole brain radiotherapy
  • Major cognitive or psychiatric impairments
  • Pregnant women
  • Allergies to: polyester, synthetic fibers
  • Patients with pacemakers or implantable cardioverter-defibrillator (ICD)
  • Patients on a Holter Monitor

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Interventions

Hexoskin Medical System

Hexoskin is a smart shirt that can detect heart rates, lung function and physical activity of patients before and after radiotherapy.

Primary outcome measure

  • Rate of patient accrual [ Time Frame: Over 12 months ]
  • Frequency of radiotherapy related adverse events [ Time Frame: Baseline to 12 months ]

Central Contacts and Locations

Central contacts

Philip Wong

416-946-4501philip.wong@rmp.uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Philip Wong, MD

416-946-4501philip.wong@rmp.uhn.ca

More Information

Sponsor

University Health Network, Toronto

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-03-05.