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Photobiomodulation in the Treatment of Hand-foot Syndrome

NCT05337423 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-08-27

No results posted yet for this study

Summary

A cytotoxic complication caused by chemotherapy is hand-foot syndrome, also known as palmar-plantar erythrodysesthesia (PPE). The mechanism is not yet clear, but it is thought that the chemotherapeutic agent generates cytotoxicity on the acral epidermis. Clinically it manifests as erythema and edema on the palms of the hands and feet, dry and scaly skin, accompanied by a sensation of tightness and pain. Extreme cases present blisters and ulcerations that may require hospitalization. It can also be accompanied by paresthesias. The main objective will be to evaluate if photobiomodulation is effective in reducing PPE induced by Capecitabine and 5-Fluorouracil chemotherapy.

It will be a 4 week treatment, with 2 groups: G1 - Moisturizing cream and Photobiomodulation; G2: Moisturizing cream and photobiomodulation sham.

Conditions

  • Erythrodysesthesia Syndrome

Interventions

DEVICE

Photobiomodulation

Group 1 will receive 630 nm LED and group 2 will receive sham treatment twice a week in the palmo-plantar areas of the hands and feet (4 J/cm2) for 4 weeks.

OTHER

Moisturizer

Both groups will receive moisturizer.

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Principal Investigators

  • Valentina Lestido, Master · Universidad Catolica de Uruguay

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2024-05-30
Completion
2024-06-30

Countries

  • Uruguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05337423 on ClinicalTrials.gov