Status:
TERMINATED
Photobiomodulation in the Treatment of Hand-foot Syndrome
Lead Sponsor:
University of Nove de Julho
Conditions:
Erythrodysesthesia Syndrome
Eligibility:
All Genders
18-100 years
Phase:
NA
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 chemotherapeuti...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients with palmo-plantar skin comorbidities,
- autoimmune comorbidities,
- amputated limbs,
- systemic infection,
- localized or regional limb infection,
- respiratory isolation,
- contact isolation
- insulin-requiring diabetics.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05337423
Start Date
March 1 2023
End Date
June 30 2024
Last Update
August 27 2025
Active Locations (2)
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1
Centro de Asistencia del Sindicato Médico del Uruguay
Montevideo, Uruguay, 11600
2
Instituto Nacional del Cáncer
Montevideo, Uruguay, 11600