Photobiomodulation in the Treatment of Hand-foot Syndrome
Primary Purpose
Erythrodysesthesia Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photobiomodulation
Moisturizer
Sponsored by
About this trial
This is an interventional treatment trial for Erythrodysesthesia Syndrome focused on measuring Hand-Food Syndrome, Low-Level Light Therapy, Quality of life
Eligibility Criteria
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 v. 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Group 1
Group 2
Arm Description
Moisturizing cream indicated and provided by the hospital (with urea) + LED treatment.
Moisturizing cream indicated and provided by the hospital (with urea) + LED sham treatment.
Outcomes
Primary Outcome Measures
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..
Secondary Outcome Measures
Chemotherapy dose
Total dose (mg) of chemotherapeutical drug used
Need of interrupting chemotherapy
The need of interrupting chemotherapy due to Palmo planar erythrodysesthesia : Yes or no
Need of reducting chemotherapy dose
The need of reducing dose of chemotherapy due to Palmo planar erythrodysesthesia: Yes or no
HSF-14
Quality of life questionnaire HSF-14
DLQI
Quality of life questionnaire - Dermatology life quality index
Full Information
NCT ID
NCT05337423
First Posted
April 4, 2022
Last Updated
December 24, 2022
Sponsor
University of Nove de Julho
1. Study Identification
Unique Protocol Identification Number
NCT05337423
Brief Title
Photobiomodulation in the Treatment of Hand-foot Syndrome
Official Title
Photobiomodulation in the Treatment of Palmar-plantar Erythrodysesthesia: Clinical, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 30, 2023 (Anticipated)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythrodysesthesia Syndrome
Keywords
Hand-Food Syndrome, Low-Level Light Therapy, Quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Moisturizing cream indicated and provided by the hospital (with urea) + LED treatment.
Arm Title
Group 2
Arm Type
Sham Comparator
Arm Description
Moisturizing cream indicated and provided by the hospital (with urea) + LED sham treatment.
Intervention Type
Device
Intervention Name(s)
Photobiomodulation
Other Intervention Name(s)
low-level laser therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Moisturizer
Intervention Description
Both groups will receive moisturizer.
Primary Outcome Measure Information:
Title
Palmo planar erythrodysesthesia grade
Description
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)
Secondary Outcome Measure Information:
Title
Chemotherapy dose
Description
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)
Title
Need of interrupting chemotherapy
Description
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)
Title
Need of reducting chemotherapy dose
Description
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)
Title
HSF-14
Description
Quality of life questionnaire HSF-14
Time Frame
Before treatment (Day 0), at half treatment (Day 14) and at the end of the treatment (Day 28)
Title
DLQI
Description
Quality of life questionnaire - Dermatology life quality index
Time Frame
Before treatment ( Day 0) and the end of the treatment (Day 28)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 v. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valentina Lestido, Master
Phone
+59894298577
Email
valentina.lestido@ucu.edu.uy
First Name & Middle Initial & Last Name or Official Title & Degree
Christiane Pavani, PhD
Phone
+551133859222
Email
chrispavani@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valentina Lestido, Master
Organizational Affiliation
Universidad Catolica de Uruguay
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Beginning 3 months following article publication.
IPD Sharing 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).
Learn more about this trial
Photobiomodulation in the Treatment of Hand-foot Syndrome
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