Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04979078

Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction

Led by Jessa Hospital · Updated on 2023-06-18

40

Participants Needed

2

Research Sites

394 weeks

Total Duration

On this page

Sponsors

J

Jessa Hospital

Lead Sponsor

H

Hasselt University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and/or soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and/or feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL). Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and/or near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.

CONDITIONS

Official Title

Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with cancer of different aetiologies
  • Undergoing chemotherapy or targeted therapy (TKIs)
  • Diagnosed with HFS or HFSR grade 1, 2, or 3 (NCI-CTCAE v5)
  • Age 18 years or older
  • Able to comply with the study protocol
  • Able to sign written informed consent
Not Eligible

You will not qualify if you...

  • Pre-existing skin rash, ulceration, or open wound in treatment areas (hand, foot)
  • Known allergy to polyurethane
  • Substance abuse or medical, psychological, or social conditions interfering with participation or evaluation
  • Any unstable condition affecting safety or compliance as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Hasselt University

Hasselt, Limburg, Belgium, 3500

Not Yet Recruiting

2

Jessa Ziekenhuis VZW

Hasselt, Limburg, Belgium, 3500

Actively Recruiting

Loading map...

Research Team

J

Jeroen Mebis, MD, PhD

CONTACT

J

Jolien Robijns, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here