Last updated 18 months ago

Photobiomodulation in the Treatment of Hand-foot Syndrome

40 patients around the world

Available in Uruguay

Methodology: randomized, controlled, double-blind, single-center clinical trial. The study population (40 participants) will be divided into two groups - Group 1: moisturizer plus LED (light emitting diode) treatment and Group 2: moisturizer plus LED sham treatment. For the application of LED light, Antares (ibramed) with P2 LED cluster (630 nm) will be applied twice a week in the palmo-plantar areas of the hands and feet (4 J/cm2) for 4 weeks. The Palmar-plantar Erythrodysesthesia (PPE) degree is the main outcome while the secondary outcomes are the data referring to the chemotherapy treatment plan (Chemotherapy dose, need of reducing drug dose or interrupting the treatment) and also the quality of life by using Hand-foot syndrome (HSF) questionnaire - HSF-14 and dermatology Life Questionnaire Index (DLQI). PPE grade and chemotherapy plan will be measured prior to the start of treatment with photobiomodulation, in the middle and at the end of it. Quality of life questionnaires (HFS-14 - Hand-foot syndrome and DLQI - dermatology Life Questionnaire Index) will be applied at the beginning and at the end of the treatment.

University of Nove de Julho

1Research sites

40Patients around the world

This study is for people with

Erythrodysesthesia Syndrome

Hand-Foot Syndrome

Requirements for the patient

To 100 Years

All Gender

Medical requirements

: Over 18 years of age.
Hospitalized or outpatients.
With oncological pathology confirmed by anatomo-pathological or cytological diagnosis.
Undergoing chemotherapy treatment oral capecitabine and 5-Fluorouracil in continuous infusion following the treatment plans protocolized by the institution: Xelox Bevacizumab, Capecitabine, Capecitabine + Radiotherapy, Folfoxiri, Xeliri-Bevacizumab, Folfox4-Bevacizumab, Docetaxel-CDDP-5-Fluorouracil Colony Stimulating Factors, mFolfirinox q/14 days, Flot.
Who develop hand-foot syndrome of greater or equal toxicity to 1 on the CTC scale NCI v. 5.0 and on Saif scale.

: Patients with palmo-plantar skin comorbidities.
Autoimmune comorbidities.
Amputated limbs.
Systemic infection.
Localized or regional limb infection.
Respiratory isolation.
Contact isolation.
Insulin-requiring diabetics.

Sites

Instituto Nacional del Cáncer

Recruiting

Joanicó 3265, 11600 Montevideo, Departamento de Montevideo, Uruguay

SponsorUniversity of Nove de Julho

Conditions

Erythrodysesthesia Syndrome Hand-Foot Syndrome

Requirements

To 100 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05337423