Palmar-Plantar Erythrodysesthesia, Palmar-Plantar Erythrodysesthesia Due to Cytotoxic Therapy
Conditions
Keywords
Palmar-Plantar Erythrodysesthesia, Cytotoxic therapy, Capecitabine, Vitamin E, Tocotrienol, Tocopherol, Topical applications, Randomised controlled trial, Urea cream, Hand-foot syndrome, Supportive care
Brief summary
This is a single-centre, phase II, three-arm, randomised controlled trial to evaluate the efficacy and safety of a cosmetic moisturising cream containing palm-oil-derived vitamin E concentrate or a similar moisturising cream without the vitamin E concentrate in addition to urea-based cream, or urea-based cream alone (1:1:1) in patients who are receiving capecitabine-based cancer therapy and develop capecitabine-associated PPE of NCI-CTCAE grade 1.
Detailed description
In this study, cancer patients from Sarawak General Hospital who are receiving capecitabine-based therapy and develop PPE of NCI-CTCAE grade 1 will be recruited and randomised 1:1:1 to three study arms. The participants who are randomised to treatment arms will receive moisturising creams with or without palm-oil-derived vitamin E concentrate, in addition to urea-based cream for external application on palms and soles. Participants who are randomised to the control arm will be required to use urea-based cream only. Both patients and investigators will be blinded to the investigational cream assignment i.e., double-blind. However, blinding will not be applicable to the use of urea cream i.e., open-label. The patients will need to use the cream(s) at least two times a day for nine to eighteen weeks or equivalent to three to six treatment cycles of capecitabine. At week-9, the patients who are planned to continue capecitabine therapy and do not develop PPE of grade 2/3 will continue to receive the study treatments for additional nine weeks or equivalent to three treatment cycles of capecitabine (extended period). The patients will be assessed for their PPE grading, symptoms, dermatological quality of life, pain score, and adverse events at the end of each capecitabine treatment cycle at the clinic.
Interventions
OTHERMoisturising cream with vitamin E concentrate
The vitamin E moisturising cream contains 3% w/w of palm-oil-derived vitamin E concentrate, consisting of the following isomers: alpha-tocopherol, alpha-tocotrienol, beta-tocotrienol, gamma-tocotrienol, and delta-tocotrienol. This formula provides a total of 1.2g tocotrienols per 100g product.
OTHERMoisturising cream without vitamin E concentrate
This moisturising cream is a similar moisturising cream but without the addition of the vitamin E concentrate
OTHERUrea cream
Urea cream (10%w/w) is used as the standard of care for PPE.
Sponsors
Avantsar Sdn. Bhd.
Universiti Sains Malaysia
Sarawak General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The use of the investigational creams, i.e. moisturising creams with or without vitamin E concentrate will be double-blinded. Both creams will be the same in colour, texture, packaging, and labelling. The patients, investigators, and blinded study personnel will blinded the patients' assignment of the investigational creams. On the other hand, the use of urea cream will be open-labelled.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years old and above 2. Able to give written consent freely 3. Receiving capecitabine at least 1 dose, as monotherapy or in combination therapy 4. Receiving urea-based cream 5. Developed PPE of NCI-CTCAE grade 1 6. Have at least three cycles of chemotherapy to complete 7. Life expectancy ≥ 6 months 8. ECOG≤2
Exclusion criteria
1. Unable to understand the information sheet and informed consent form 2. Allergy history towards vitamin E and its isoforms or any components of the investigational products 3. Unable to tolerate urea-based products 4. Other pre-existing dermatological diseases or conditions that may interfere the evaluation of PPE 5. PPE complicated with infection 6. Receiving other agent(s) that are known to cause PPE or hand- foot syndrome and hand-foot skin reactions 7. Receiving long-term topical or systemic steroid treatment (except as part of pre-or post-medications of chemotherapy regime) 8. Pregnant or lactating mother 9. Participating in another interventional trial 10. Refuses to interrupt his/her usual care 11. Anticipated inability to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palmar-plantar erythrodysesthesia (PPE) resolution | At Day 22, Day 43, Day 64, and Day 127 of cream treatment | Number of participants who have resolved PPE (NCI-CTCAE grade 1 to 0) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time-to-PPE resolution | At Day 22, Day 43, Day 64, and Day 127 of cream treatment | Time-to-PPE resolution via patient self-reported symptoms in standardised diary |
| Time-to-PPE worsening | At Day 22, Day 43, Day 64, and Day 127 of cream treatment | Time-to-PPE worsening via patient self-reported symptoms in standardised diary |
| Dermatology Life Quality Index (0 - 30) | At Day 22, Day 43, Day 64, and Day 127 of cream treatment | The Dermatology Life Quality Index (DLQI) consists of 10 questions, and each question is assigned a score (0 to 3). The total score ranges from 0 to 30, with higher scores indicating greater impairment in the individual's quality of life. |
| Palmar-plantar erythrodysesthesia (PPE) worsening | At Day 22, Day 43, Day 64, and Day 127 of cream treatment | Number of participants who have worsened PPE (NCI-CTCAE grade 1 to 2/3) |
| Overall adverse events | At Day 22, Day 43, Day 64, and Day 127 of cream treatment | Frequency of overall adverse events |
| Dermatology-related adverse events | At Day 22, Day 43, Day 64, and Day 127 of cream treatment | Frequency of dermatology-related adverse events |
| Pain score (numerical scale of 1 to 10) | At Day 22, Day 43, Day 64, and Day 127 of cream treatment | The pain score is assessed using a 1-10 numeric rating pain scale, where 1 represents no pain at all, and 10 is the worst pain. |
Countries
Malaysia
Outcome results
None listed