Erythrodysesthesia SyndromeNCT05337423
Photobiomodulation in the Treatment of Hand-foot Syndrome
A study testing Photobiomodulation and Moisturizer in people with Erythrodysesthesia Syndrome, run by University of Nove de Julho at 2 sites in Uruguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Erythrodysesthesia Syndrome
- What is being tested?
- Photobiomodulation and Moisturizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 2 sitesUruguay
- Study dates
- 1 Mar 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with palmo-plantar skin comorbidities,
- autoimmune comorbidities,
- amputated limbs,
- systemic infection,
- localized or regional limb infection,
- respiratory isolation,
- contact isolation
- insulin-requiring diabetics.
Trial locations and contacts
2 sites in 1 country.
Uruguay2 sites
Centro de Asistencia del Sindicato Médico del Uruguay
Montevideo, 11600
Instituto Nacional del Cáncer
Montevideo, 11600
About this study
Official title: Photobiomodulation in the Treatment of Palmar-plantar Erythrodysesthesia: Clinical, Randomized, Controlled Study
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.
Read the 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.
- Conditions
- Erythrodysesthesia Syndrome
- Being tested
- Photobiomodulation, Moisturizer
- Keywords
- Hand-Food Syndrome, Low-Level Light Therapy, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhotobiomodulationDevice
Also called low-level laser therapy
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.
MoisturizerOther
Both groups will receive moisturizer.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Moisturizing cream indicated and provided by the hospital (with urea) + LED treatment. Receives: Device: Photobiomodulation; Other: Moisturizer |
| Group 2 | Sham comparator | Moisturizing cream indicated and provided by the hospital (with urea) + LED sham treatment. Receives: Other: Moisturizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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..
Measured: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
Secondary outcomes (8)
Chemotherapy dose
Total dose (mg) of chemotherapeutical drug used
Measured: 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
Measured: 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
Measured: 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
Measured: Before treatment (Day 0) and at the end of the treatment (Day 28)
DLQI
Quality of life questionnaire - Dermatology life quality index
Measured: 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.
Measured: 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
Measured: 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
Measured: Before treatment ( Day 0) and the end of the treatment (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Mar 2023
- Primary completion30 May 2024
- Study completion30 Jun 2024
Why it stopped: Recruitment over one year resulted in only six patients treated. With the conclusion of the principal investigator's doctoral program and limited resources to continue, the study was terminated due to time and availability constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erythrodysesthesia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Pavani, University of Nove de Julho
- Investigators
- Valentina Lestido, Master, Principal investigator, Universidad Catolica de Uruguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337423
- Sponsor's protocol ID
- UninoveUCU
- Status last verified
- Aug 2025
- First submitted
- 4 Apr 2022
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 38657999
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photobiomodulation in the Treatment of Palmar-plantar Erythrodysesthesia: Clinical, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05337423
- Acronym / sponsor ID
- UninoveUCU
- Conditions
- Erythrodysesthesia Syndrome
- Keywords
- Hand-Food Syndrome, Low-Level Light Therapy, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment over one year resulted in only six patients treated. With the conclusion of the principal investigator's doctoral program and limited resources to continue, the study was terminated due to time and availability constraints.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Photobiomodulation, Other: MoisturizerMoisturizing cream indicated and provided by the hospital (with urea) + LED treatment. |
| Group 2 | Sham comparator | Other: MoisturizerMoisturizing cream indicated and provided by the hospital (with urea) + LED sham treatment. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Patients with palmo-plantar skin comorbidities,
- autoimmune comorbidities,
- amputated limbs,
- systemic infection,
- localized or regional limb infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhotobiomodulationAlso: low-level laser therapyGroup 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. | Device | Group 1 |
| MoisturizerBoth groups will receive moisturizer. | Other | Group 1, Group 2 |
Primary outcome
Palmo planar erythrodysesthesia grade
Time frame: 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..
8 secondary outcomes
Chemotherapy dose
Time frame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
Need of interrupting chemotherapy
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
Time frame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
HSF-14
Time frame: Before treatment (Day 0) and at the end of the treatment (Day 28)
DLQI
Time frame: Before treatment ( Day 0) and the end of the treatment (Day 28)
Questionnaire
Time frame: Follow up (day 60)
Peripheral Sensory Neuropathy World Health Organization (WHO) Scale
Time frame: Before treatment ( Day 0) and the end of the treatment (Day 28)
Peripheral Sensory Neuropathy Eastern Clinical Oncology Group (ECOG) Scale
Time frame: Before treatment ( Day 0) and the end of the treatment (Day 28)
Results and safety
The study was stopped early (reason given: Recruitment over one year resulted in only six patients treated. With the conclusion of the principal investigator's doctoral program and limited resources to continue, the study was terminated due to time and availability constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 38657999Lestido 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.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valentina Lestido, Master principal investigator
Universidad Catolica de Uruguay
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photobiomodulation and Moisturizer in people with Erythrodysesthesia Syndrome, run by University of Nove de Julho at 2 sites in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment over one year resulted in only six patients treated. With the conclusion of the principal investigator's doctoral program and limited resources to continue, the study was terminated due to time and availability constraints.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palmo planar erythrodysesthesia grade (time frame: Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05337423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.