An interventional study of Photobiomodulation and Moisturizer in Erythrodysesthesia Syndrome, sponsored by University of Nove de Julho. Terminated at 2 sites in Uruguay. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
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.
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 is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Moisturizing cream indicated and provided by the hospital (with urea) + LED treatment.
Device: Photobiomodulation · Other: Moisturizer
Moisturizing cream indicated and provided by the hospital (with urea) + LED sham treatment.
Other: Moisturizer
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
Both groups will receive moisturizer.
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..
Time frame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
Chemotherapy dose
Total dose (mg) of chemotherapeutical drug used
Time frame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
Need of interrupting chemotherapy
The need of interrupting chemotherapy due to Palmo planar erythrodysesthesia : Yes or no
Time frame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
Need of reducting chemotherapy dose
The need of reducing dose of chemotherapy due to Palmo planar erythrodysesthesia: Yes or no
Time frame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
HSF-14
Quality of life questionnaire HSF-14
Time frame: Before treatment (Day 0) and at the end of the treatment (Day 28)
DLQI
Quality of life questionnaire - Dermatology life quality index
Time frame: Before treatment ( Day 0) and the end of the treatment (Day 28)
Questionnaire
Questionnaire developed by researchers evaluating parameters in hands and feet related to daily activities.
Time frame: Follow up (day 60)
Peripheral Sensory Neuropathy World Health Organization (WHO) Scale
Peripheral Sensory Neuropathy World Health Organization (WHO) Scale Grade 0: No; grade 1: symptoms Presence of paresthesias and/ or decreased deep tendon reflexes; Grade 2: Severe paresthesias and/or light muscle weakness Grade 3: Intolerable paresthesias and/or marked weakness , Grade 4: Paralysis
Time frame: Before treatment ( Day 0) and the end of the treatment (Day 28)
Peripheral Sensory Neuropathy Eastern Clinical Oncology Group (ECOG) Scale
Peripheral Sensory Neuropathy Eastern Clinical Oncology Group (ECOG) Scale Grade 0, None, or no change; Grade 1: Loss of deep tendon reflexes, mild paresthesias. Grade 2: Mild or moderate objective sensory loss; moderate paresthesias. Grade 3: Severe objective sensory loss, or paresthesias that interfere with function
Time frame: Before treatment ( Day 0) and the end of the treatment (Day 28)
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared. The sharing will begin 3 months following article publication. Researchers who provide a methodologically sound proposal will receive the access. Proposals should be directed to chrispavani@gmail.com. To gain access, data requestors will need to sign a data access agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, 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).
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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