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

Last updated: June 15, 2023
Sponsor: Jessa Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Photobiomodulation therapy (PBMT)

Clinical Study ID

NCT04979078
2021/071
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with cancer of different aetiologies
  • Undergoing chemotherapy or targeted therapy (TKIs)
  • Diagnosed with HFS-HFSR grade 1, 2 or 3 (National Cancer Institute - CommonTerminology Criteria for Adverse Events, NCI-CTCAE v5)
  • Age ≥ 18 years
  • Able to comply to the study protocol
  • Able to sign written informed consent

Exclusion

Exclusion Criteria:

  • Pre-existing skin rash, ulceration or open wound in the treatment area (hand, foot)
  • Known allergy to polyurethane
  • Substance abuse patients or patients with medical, psychological or social conditionsthat may interfere with the patient's participation in the study or evaluation of thestudy results as judged by the investigator
  • Any condition that is unstable or could affect the safety of the patient and theircompliance in the study as judged by the investigator

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Photobiomodulation therapy (PBMT)
Phase:
Study Start date:
January 12, 2022
Estimated Completion Date:
August 31, 2029

Study Description

The aim of this study is to evaluate the efficacy of PBMT in the management of HFS and HFSR in patients with cancer treated with chemotherapy or TKIs up to 2 weeks post-PBMT.

Primary objective: The study seeks primarily to determine the effectiveness of PBMT in reducing the severity of HFS and HFSR in patients with cancer of different etiology undergoing chemotherapy or TKIs, diagnosed with HFS or HFSR (grade 1-3).

Secondary objective 1 : HFS/HFSR-related symptoms

A secondary aim of this study is to evaluate if PBMT and can reduce the HFS/HSFR-related symptoms during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 2: Quality of life

A secondary aim of this study is to evaluate if PBMT can improve the patients' QoL during PBM treatment and up to 2 weeks post-PBMT

Secondary Objective 3: Patient satisfaction

A secondary aim of this study is to evaluate if patients are satisfied with PBMT as a treatment for HFS and HFSR during the treatment sessions and up to 2 weeks post-PBMT

Secondary Objective 4: PBM safety

A secondary aim of this study is to evaluate the safety of PBM in oncologic patients up to 5 years post-PBMT.

Connect with a study center

  • Hasselt University

    Hasselt, Limburg 3500
    Belgium

    Site Not Available

  • Jessa Ziekenhuis VZW

    Hasselt, Limburg 3500
    Belgium

    Active - Recruiting

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