Photobiomodulation in the Treatment of Hand-foot Syndrome

NCT05337423 | Terminated

• 1 other identifier: UninoveUCU
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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.

Conditions

Erythrodysesthesia Syndrome

Keywords

Hand-Food Syndrome; Low-Level Light Therapy; Quality of life

Outcome Measures

Primary Outcomes (1)

• Palmo planar erythrodysesthesia grade

  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..

  Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)

Secondary Outcomes (8)

• Chemotherapy dose

  Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)

• Need of interrupting chemotherapy

  Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)

• Need of reducting chemotherapy dose

  Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)

• HSF-14

  Before treatment (Day 0) and at the end of the treatment (Day 28)

• DLQI

  Before treatment ( Day 0) and the end of the treatment (Day 28)

Study Arms (2)

Group 1

EXPERIMENTAL

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

Device: Photobiomodulation; Other: Moisturizer

Group 2

SHAM COMPARATOR

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

Other: Moisturizer

Interventions

Photobiomodulation DEVICE

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.

Also known as: low-level laser therapy

Group 1

Moisturizer OTHER

Both groups will receive moisturizer.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. Et al. for dark skin

You may not qualify if:

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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (2)

Centro de Asistencia del Sindicato Médico del Uruguay

Montevideo, 11600, Uruguay

Location

Instituto Nacional del Cáncer

Montevideo, 11600, Uruguay

Location

Related Publications (1)

• Lestido V, Rodriguez F, Rodriguez A, Pombo V, Barrios R, Pavani C. Photobiomodulation in the treatment of palmar-plantar erythrodysesthesia: a randomised controlled clinical study protocol. BMJ Open. 2024 Apr 23;14(4):e081459. doi: 10.1136/bmjopen-2023-081459.

  PMID: 38657999 DERIVED

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Valentina Lestido, Master

  Universidad Catolica de Uruguay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

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

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 20, 2022
• Study Start: March 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: June 30, 2024
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal.Proposals should be directed to xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included).

Locations

UR (2)