Photobiomodulation in the Treatment of Hand-foot Syndrome

Sponsor

University of Nove de Julho (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05337423

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Erythrodysesthesia Syndrome	Device: Photobiomodulation Other: Moisturizer	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Group of participants will receive skin moisturizer and photobiomodulation sham while another group will receive the skin moisturizer and the active photobiomodulation treatment.A Group of participants will receive skin moisturizer and photobiomodulation sham while another group will receive the skin moisturizer and the active photobiomodulation treatment.

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.

Primary Purpose:

Treatment

Official Title:

Photobiomodulation in the Treatment of Palmar-plantar Erythrodysesthesia: Clinical, Randomized, Controlled Study

Anticipated Study Start Date :

May 30, 2022

Anticipated Primary Completion Date :

Dec 30, 2024

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Moisturizing cream indicated and provided by the hospital (with urea) + LED treatment.	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 Names: low-level laser therapy Other: Moisturizer Both groups will receive moisturizer.
Sham Comparator: Group 2 Moisturizing cream indicated and provided by the hospital (with urea) + LED sham treatment.	Other: Moisturizer Both groups will receive moisturizer.

Arm

Intervention/Treatment

Experimental: Group 1

Moisturizing cream indicated and provided by the hospital (with urea) + LED treatment.

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 Names:

low-level laser therapy

Other: Moisturizer

Both groups will receive moisturizer.

Sham Comparator: Group 2

Moisturizing cream indicated and provided by the hospital (with urea) + LED sham treatment.

Other: Moisturizer

Both groups will receive moisturizer.

Outcome Measures

Primary Outcome Measures

Palmo planar erythrodysesthesia grade [Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)]
3 Epp grades were stablished by CTC NCI being: Grade 1 - Minimal palmoplantar skin changes, without pain (erythema, edema, hyperkeratosis),; grade 2 - Skin changes (scaling, blisters, fissures, edema, hyperkeratosis) with pain, limiting instrumental activities; grade 3 - Severe skin changes (scaling, blisters, fissures, edema, hyperkeratosis, bleeding), with pain..

Secondary Outcome Measures

Chemotherapy dose [Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)]
Total dose (mg) of chemotherapeutical drug used
Need of interrupting chemotherapy [Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)]
The need of interrupting chemotherapy due to Palmo planar erythrodysesthesia : Yes or no
Need of reducting chemotherapy dose [Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)]
The need of reducing dose of chemotherapy due to Palmo planar erythrodysesthesia: Yes or no
HSF-14 [Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)]
Quality of life questionnaire HSF-14
DLQI [Before treatment ( Day 0) and the end of the treatment (Day 28)]
Quality of life questionnaire - Dermatology life quality index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

5.0 and on Saif scale. Et al. for dark skin

Exclusion Criteria:

Patients with palmo-plantar skin comorbidities,
autoimmune comorbidities,
amputated limbs,
systemic infection,
localized or regional limb infection,
respiratory isolation,
contact isolation
insulin-requiring diabetics.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Nove de Julho

Investigators

Principal Investigator: Valentina Lestido, Master, Universidad Catolica de Uruguay

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Christiane Pavani, Clinical Professor, University of Nove de Julho

ClinicalTrials.gov Identifier:

NCT05337423

Other Study ID Numbers:

UninoveUCU

First Posted:

Apr 20, 2022

Last Update Posted:

Apr 20, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Christiane Pavani, Clinical Professor, University of Nove de Julho

Hand-Food Syndrome

Low-Level Light Therapy

Quality of life

Additional relevant MeSH terms:

Syndrome

Study Results

No Results Posted as of Apr 20, 2022