NCT04979078

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
39mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
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 Progress57%
Jan 2022Aug 2029

First Submitted

Initial submission to the registry

July 16, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 12, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Expected
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

2.6 years

First QC Date

July 16, 2021

Last Update Submit

June 15, 2023

Conditions

Hand-foot SyndromeHand-foot Skin Reaction

Keywords

DermatologyOncologyPhotobiomodulationSkin toxicityHand-foot syndromeHand-foot skin reactionHand-foot skin toxicitySupportive cancer careLight therapy

Outcome Measures

Primary Outcomes (15)

  • Skin reaction evaluation - CTCAE

    The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.

    Baseline

  • Skin reaction evaluation - CTCAE

    The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.

    Session 3 of PBMT

  • Skin reaction evaluation - CTCAE

    The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.

    Session 6 of PBMT

  • Skin reaction evaluation - CTCAE

    The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.

    Final PBM session (session 9)

  • Skin reaction evaluation - CTCAE

    The severity of the skin reactions will be evaluated by the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5.

    2 weeks post-PBMT

  • Skin reaction evaluation - WHO

    The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR

    Baseline

  • Skin reaction evaluation - WHO

    The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR

    Session 3 of PBMT

  • Skin reaction evaluation - WHO

    The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR

    Session 6 of PBMT

  • Skin reaction evaluation - WHO

    The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR

    Final PBM session (session 9)

  • Skin reaction evaluation - WHO

    The severity of the skin reactions will be evaluated by the World Health Association (WHO) grading scale for HFS/HFSR

    2 weeks post-PBMT

  • Clinical photograph

    A clinical photograph of the palm of patients' hands and sole of their feet

    Baseline

  • Clinical photograph

    A clinical photograph of the palm of patients' hands and sole of their feet

    Session 3 of PBMT

  • Clinical photograph

    A clinical photograph of the palm of patients' hands and sole of their feet

    Session 6 of PBMT

  • Clinical photograph

    A clinical photograph of the palm of patients' hands and sole of their feet

    Final PBM session (session 9)

  • Clinical photograph

    A clinical photograph of the palm of patients' hands and sole of their feet

    2 weeks post-PBMT

Secondary Outcomes (17)

  • Patient subjective evaluation of skin reactions

    Baseline

  • Patient subjective evaluation of skin reactions

    Session 3 of PBMT

  • Patient subjective evaluation of skin reactions

    Session 6 of PBMT

  • Patient subjective evaluation of skin reactions

    Final PBM session (Session 9)

  • Patient subjective evaluation of skin reactions

    2 weeks post-PBMT

  • +12 more secondary outcomes

Other Outcomes (23)

  • General patient-, disease-, and treatment-related information

    Baseline

  • General patient-, disease-, and treatment-related information

    Final PBM session (session 9)

  • General patient-, disease-, and treatment-related information

    2 weeks post-PBMT

  • +20 more other outcomes

Study Arms (1)

Experimental group

EXPERIMENTAL

The experimental group receives 9 sessions of photobiomodulation therapy (3x/week for 3 weeks).

Device: Photobiomodulation therapy (PBMT)

Interventions

Photobiomodulation therapy (PBMT)DEVICE

Patients will receive PBM on the sole of their feet and palms of their hands

Experimental group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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 conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
  • Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hasselt University

Hasselt, Limburg, 3500, Belgium

NOT YET RECRUITING

Jessa Ziekenhuis VZW

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Hand-Foot SyndromeNeoplasms

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Drug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Jeroen Mebis, MD, PhD

    Head of Medical Oncology Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeroen Mebis, MD, PhD

CONTACT

+32 11 33 72 21Jeroen.mebis@jessazh.be

Jolien Robijns, PhD

CONTACT

+32 11 33 72 29jolien.robijns@uhasselt.be

Study Design

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

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 27, 2021

Study Start

January 12, 2022

Primary Completion

August 1, 2024

Study Completion (Estimated)

August 1, 2029

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)