Palmar-Plantar ErythrodysesthesiaECaPPENCT05939726
Efficacy and Safety of Moisturising Cream With or Without Vitamin E and Urea Cream in Palmar-plantar Erythrodysesthesia
A study testing Moisturising cream with vitamin E concentrate, Moisturising cream without vitamin E concentrate and Urea cream in people with Palmar-Plantar Erythrodysesthesia and Palmar-Plantar Erythrodysesthesia Due to Cytotoxic Therapy, run by Sarawak General Hospital at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palmar-Plantar Erythrodysesthesia, Palmar-Plantar Erythrodysesthesia Due to Cytotoxic Therapy
- What is being tested?
- Moisturising cream with vitamin E concentrate, Moisturising cream without vitamin E concentrate and Urea cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteMalaysia
- Study dates
- 16 May 2023to 20 Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and above
- Able to give written consent freely
- Receiving capecitabine at least 1 dose, as monotherapy or in combination therapy
- Receiving urea-based cream
- Developed PPE of NCI-CTCAE grade 1
- Have at least three cycles of chemotherapy to complete
- Life expectancy ≥ 6 months
- ECOG≤2
Who cannot join
- Unable to understand the information sheet and informed consent form
- Allergy history towards vitamin E and its isoforms or any components of the investigational products
- Unable to tolerate urea-based products
- Other pre-existing dermatological diseases or conditions that may interfere the evaluation of PPE
- PPE complicated with infection
- Receiving other agent(s) that are known to cause PPE or hand- foot syndrome and hand-foot skin reactions
Show all 11Show fewer
- Receiving long-term topical or systemic steroid treatment (except as part of pre-or post-medications of chemotherapy regime)
- Pregnant or lactating mother
- Participating in another interventional trial
- Refuses to interrupt his/her usual care
- Anticipated inability to follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Randomised Controlled Trial to Evaluate the Efficacy and Safety of Moisturising Creams With or Without Palm-oil-derived Vitamin E Concentrate in Addition to Urea-based Cream or Urea-based Cream Alone in Capecitabine-associated Palmar-Plantar Erythrodysesthesia (ECaPPE)
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.
Read the 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.
- Conditions
- Palmar-Plantar Erythrodysesthesia, Palmar-Plantar Erythrodysesthesia Due to Cytotoxic Therapy
- Being tested
- Moisturising cream with vitamin E concentrate, Moisturising cream without vitamin E concentrate, Urea cream
- Keywords
- Palmar-Plantar Erythrodysesthesia, Cytotoxic therapy, Capecitabine, Vitamin E, Tocotrienol, Tocopherol, Topical applications, Randomised controlled trial, Urea cream, Hand-foot syndrome, Supportive care
- Medical subject headings
- Hand-Foot Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moisturising cream with vitamin E concentrateOther
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.
Moisturising cream without vitamin E concentrateOther
This moisturising cream is a similar moisturising cream but without the addition of the vitamin E concentrate
Urea creamOther
Urea cream (10%w/w) is used as the standard of care for PPE.
| Study group | Role | What they receive |
|---|---|---|
| Moisturising Cream with Vitamin E and Urea Cream | Experimental | Participants who are randomised in this arm will receive a moisturising cream containing palm-oil-derived vitamin E concentrate for external application on both palms and soles, in addition to urea-based cream as the standard of care for PPE management. They will be required to apply the investigational cream first, followed by the urea-based cream, at least two times a day. Receives: Other: Moisturising cream with vitamin E concentrate; Other: Urea cream |
| Moisturising Cream without Vitamin E and Urea Cream | Experimental | Participants who are randomised to this arm will receive a basic or plain moisturising cream without Vitamin E for external application on both palms and soles, in addition to urea-based cream as the standard of care for PPE management. They will be required to apply the investigational cream first, followed by the urea-based cream, at least two times a day. Receives: Other: Moisturising cream without vitamin E concentrate; Other: Urea cream |
| Urea Cream Only | Active comparator | Participants who are randomised to this arm will receive urea-based cream only as the standard of care for PPE management. They will be required to use the urea cream at least twice a day. Receives: Other: Urea cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palmar-plantar erythrodysesthesia (PPE) resolution
Number of participants who have resolved PPE (NCI-CTCAE grade 1 to 0)
Measured: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Secondary outcomes (7)
Palmar-plantar erythrodysesthesia (PPE) worsening
Number of participants who have worsened PPE (NCI-CTCAE grade 1 to 2/3)
Measured: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE resolution
Time-to-PPE resolution via patient self-reported symptoms in standardised diary
Measured: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE worsening
Time-to-PPE worsening via patient self-reported symptoms in standardised diary
Measured: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Dermatology Life Quality Index (0 - 30)
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.
Measured: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Pain score (numerical scale of 1 to 10)
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.
Measured: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Overall adverse events
Frequency of overall adverse events
Measured: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Dermatology-related adverse events
Frequency of dermatology-related adverse events
Measured: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start16 May 2023
- Primary completion22 May 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Palmar-Plantar ErythrodysesthesiaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarawak General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Avantsar Sdn. Bhd., Universiti Sains Malaysia
- Responsible party
- Principal investigator, Voon Pei Jye, Sarawak General Hospital
- Investigators
- Pei Jye Voon, M.D, Principal investigator, Sarawak General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939726
- Sponsor's protocol ID
- CRC005-ECaPPE
- Acronym
- ECaPPE
- Status last verified
- Jan 2026
- First submitted
- 25 Jun 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gressett SM, Stanford BL, Hardwicke F. Management of hand-foot syndrome induced by capecitabine. J Oncol Pharm Pract. 2006 Sep;12(3):131-41. doi: 10.1177/1078155206069242.
PubMed 17022868Nikolaou V, Syrigos K, Saif MW. Incidence and implications of chemotherapy related hand-foot syndrome. Expert Opin Drug Saf. 2016 Dec;15(12):1625-1633. doi: 10.1080/14740338.2016.1238067. Epub 2016 Oct 8.
PubMed 27718746Kwakman JJM, Elshot YS, Punt CJA, Koopman M. Management of cytotoxic chemotherapy-induced hand-foot syndrome. Oncol Rev. 2020 May 13;14(1):442. doi: 10.4081/oncol.2020.442. eCollection 2020 Feb 18.
PubMed 32431787Lou Y, Wang Q, Zheng J, Hu H, Liu L, Hong D, Zeng S. Possible Pathways of Capecitabine-Induced Hand-Foot Syndrome. Chem Res Toxicol. 2016 Oct 17;29(10):1591-1601. doi: 10.1021/acs.chemrestox.6b00215. Epub 2016 Sep 28.
PubMed 27631426Milano G, Etienne-Grimaldi MC, Mari M, Lassalle S, Formento JL, Francoual M, Lacour JP, Hofman P. Candidate mechanisms for capecitabine-related hand-foot syndrome. Br J Clin Pharmacol. 2008 Jul;66(1):88-95. doi: 10.1111/j.1365-2125.2008.03159.x. Epub 2008 Mar 13.
PubMed 18341672Zhang RX, Wu XJ, Lu SX, Pan ZZ, Wan DS, Chen G. The effect of COX-2 inhibitor on capecitabine-induced hand-foot syndrome in patients with stage II/III colorectal cancer: a phase II randomized prospective study. J Cancer Res Clin Oncol. 2011 Jun;137(6):953-7. doi: 10.1007/s00432-010-0958-9. Epub 2010 Nov 27.
PubMed 21113620Hofheinz RD, Gencer D, Schulz H, Stahl M, Hegewisch-Becker S, Loeffler LM, Kronawitter U, Bolz G, Potenberg J, Tauchert F, Al-Batran SE, Schneeweiss A. Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group. J Clin Oncol. 2015 Aug 1;33(22):2444-9. doi: 10.1200/JCO.2014.60.4587. Epub 2015 Jun 29.
PubMed 26124485Wolf SL, Qin R, Menon SP, Rowland KM Jr, Thomas S, Delaune R, Christian D, Pajon ER Jr, Satele DV, Berenberg JL, Loprinzi CL; North Central Cancer Treatment Group Study N05C5. Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. J Clin Oncol. 2010 Dec 10;28(35):5182-7. doi: 10.1200/JCO.2010.31.1431. Epub 2010 Nov 8.
PubMed 21060036Hoesly FJ, Baker SG, Gunawardane ND, Cotliar JA. Capecitabine-induced hand-foot syndrome complicated by pseudomonal superinfection resulting in bacterial sepsis and death: case report and review of the literature. Arch Dermatol. 2011 Dec;147(12):1418-23. doi: 10.1001/archdermatol.2011.320.
PubMed 22184763Kara IO, Sahin B, Erkisi M. Palmar-plantar erythrodysesthesia due to docetaxel-capecitabine therapy is treated with vitamin E without dose reduction. Breast. 2006 Jun;15(3):414-24. doi: 10.1016/j.breast.2005.07.007. Epub 2005 Sep 26.
PubMed 16188440Yamamoto D, Yamamoto C, Iwase S, Kuroda Y, Odagiri H, Nagumo Y. Efficacy of Vitamin E Treatment for Hand-Foot Syndrome in Patients Receiving Capecitabine. Breast Care (Basel). 2010;5(6):415-416. doi: 10.1159/000322660. Epub 2010 Nov 26. No abstract available.
PubMed 21494409Bozkurt Duman B, Kara B, Oguz Kara I, Demiryurek H, Aksungur E. Hand-foot syndrome due to sorafenib in hepatocellular carcinoma treated with vitamin E without dose modification; a preliminary clinical study. J BUON. 2011 Oct-Dec;16(4):759-64.
PubMed 22331734
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomised Controlled Trial to Evaluate the Efficacy and Safety of Moisturising Creams With or Without Palm-oil-derived Vitamin E Concentrate in Addition to Urea-based Cream or Urea-based Cream Alone in Capecitabine-associated Palmar-Plantar Erythrodysesthesia (ECaPPE)
- ClinicalTrials.gov ID
- NCT05939726
- Acronym / sponsor ID
- ECaPPE / CRC005-ECaPPE
- Conditions
- Palmar-Plantar Erythrodysesthesia, Palmar-Plantar Erythrodysesthesia Due to Cytotoxic Therapy
- Keywords
- Palmar-Plantar Erythrodysesthesia, Cytotoxic therapy, Capecitabine, Vitamin E, Tocotrienol, Tocopherol, Topical applications, Randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Sarawak General HospitalUniversity, hospital or other
- Collaborators
- Avantsar Sdn. Bhd., Universiti Sains Malaysia
- Study start
- 16 May 2023 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 11 Jul 2023 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moisturising Cream with Vitamin E and Urea Cream | Experimental | Other: Moisturising cream with vitamin E concentrate, Other: Urea creamParticipants who are randomised in this arm will receive a moisturising cream containing palm-oil-derived vitamin E concentrate for external application on both palms and soles, in addition to urea-based cream as the standard of care for PPE management. They will be required to apply the investigational cream first, followed by the urea-based cream, at least two times a day. |
| Moisturising Cream without Vitamin E and Urea Cream | Experimental | Other: Moisturising cream without vitamin E concentrate, Other: Urea creamParticipants who are randomised to this arm will receive a basic or plain moisturising cream without Vitamin E for external application on both palms and soles, in addition to urea-based cream as the standard of care for PPE management. They will be required to apply the investigational cream first, followed by the urea-based cream, at least two times a day. |
| Urea Cream Only | Active comparator | Other: Urea creamParticipants who are randomised to this arm will receive urea-based cream only as the standard of care for PPE management. They will be required to use the urea cream at least twice a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years old and above
- Able to give written consent freely
- Receiving capecitabine at least 1 dose, as monotherapy or in combination therapy
- Receiving urea-based cream
- Developed PPE of NCI-CTCAE grade 1
Key exclusion criteria (11 listed)
- Unable to understand the information sheet and informed consent form
- Allergy history towards vitamin E and its isoforms or any components of the investigational products
- Unable to tolerate urea-based products
- Other pre-existing dermatological diseases or conditions that may interfere the evaluation of PPE
- PPE complicated with 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 |
|---|---|---|
| Moisturising cream with vitamin E concentrateThe 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. | Other | Moisturising Cream with Vitamin E and Urea Cream |
| Moisturising cream without vitamin E concentrateThis moisturising cream is a similar moisturising cream but without the addition of the vitamin E concentrate | Other | Moisturising Cream without Vitamin E and Urea Cream |
| Urea creamUrea cream (10%w/w) is used as the standard of care for PPE. | Other | Moisturising Cream with Vitamin E and Urea Cream, Moisturising Cream without Vitamin E and Urea Cream, Urea Cream Only |
Primary outcome
Palmar-plantar erythrodysesthesia (PPE) resolution
Time frame: 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)
7 secondary outcomes
Palmar-plantar erythrodysesthesia (PPE) worsening
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE resolution
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Time-to-PPE worsening
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Dermatology Life Quality Index (0 - 30)
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Pain score (numerical scale of 1 to 10)
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Overall adverse events
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Dermatology-related adverse events
Time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Background: PubMed 17022868Gressett SM, Stanford BL, Hardwicke F. Management of hand-foot syndrome induced by capecitabine. J Oncol Pharm Pract. 2006 Sep;12(3):131-41. doi: 10.1177/1078155206069242.
- Background: PubMed 27718746Nikolaou V, Syrigos K, Saif MW. Incidence and implications of chemotherapy related hand-foot syndrome. Expert Opin Drug Saf. 2016 Dec;15(12):1625-1633. doi: 10.1080/14740338.2016.1238067. Epub 2016 Oct 8.
- Background: PubMed 32431787Kwakman JJM, Elshot YS, Punt CJA, Koopman M. Management of cytotoxic chemotherapy-induced hand-foot syndrome. Oncol Rev. 2020 May 13;14(1):442. doi: 10.4081/oncol.2020.442. eCollection 2020 Feb 18.
- Background: PubMed 27631426Lou Y, Wang Q, Zheng J, Hu H, Liu L, Hong D, Zeng S. Possible Pathways of Capecitabine-Induced Hand-Foot Syndrome. Chem Res Toxicol. 2016 Oct 17;29(10):1591-1601. doi: 10.1021/acs.chemrestox.6b00215. Epub 2016 Sep 28.
- Background: PubMed 18341672Milano G, Etienne-Grimaldi MC, Mari M, Lassalle S, Formento JL, Francoual M, Lacour JP, Hofman P. Candidate mechanisms for capecitabine-related hand-foot syndrome. Br J Clin Pharmacol. 2008 Jul;66(1):88-95. doi: 10.1111/j.1365-2125.2008.03159.x. Epub 2008 Mar 13.
- Background: PubMed 21113620Zhang RX, Wu XJ, Lu SX, Pan ZZ, Wan DS, Chen G. The effect of COX-2 inhibitor on capecitabine-induced hand-foot syndrome in patients with stage II/III colorectal cancer: a phase II randomized prospective study. J Cancer Res Clin Oncol. 2011 Jun;137(6):953-7. doi: 10.1007/s00432-010-0958-9. Epub 2010 Nov 27.
- Background: PubMed 26124485Hofheinz RD, Gencer D, Schulz H, Stahl M, Hegewisch-Becker S, Loeffler LM, Kronawitter U, Bolz G, Potenberg J, Tauchert F, Al-Batran SE, Schneeweiss A. Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group. J Clin Oncol. 2015 Aug 1;33(22):2444-9. doi: 10.1200/JCO.2014.60.4587. Epub 2015 Jun 29.
- Background: PubMed 21060036Wolf SL, Qin R, Menon SP, Rowland KM Jr, Thomas S, Delaune R, Christian D, Pajon ER Jr, Satele DV, Berenberg JL, Loprinzi CL; North Central Cancer Treatment Group Study N05C5. Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. J Clin Oncol. 2010 Dec 10;28(35):5182-7. doi: 10.1200/JCO.2010.31.1431. Epub 2010 Nov 8.
- Background: PubMed 22184763Hoesly FJ, Baker SG, Gunawardane ND, Cotliar JA. Capecitabine-induced hand-foot syndrome complicated by pseudomonal superinfection resulting in bacterial sepsis and death: case report and review of the literature. Arch Dermatol. 2011 Dec;147(12):1418-23. doi: 10.1001/archdermatol.2011.320.
- Background: PubMed 16188440Kara IO, Sahin B, Erkisi M. Palmar-plantar erythrodysesthesia due to docetaxel-capecitabine therapy is treated with vitamin E without dose reduction. Breast. 2006 Jun;15(3):414-24. doi: 10.1016/j.breast.2005.07.007. Epub 2005 Sep 26.
- Background: PubMed 21494409Yamamoto D, Yamamoto C, Iwase S, Kuroda Y, Odagiri H, Nagumo Y. Efficacy of Vitamin E Treatment for Hand-Foot Syndrome in Patients Receiving Capecitabine. Breast Care (Basel). 2010;5(6):415-416. doi: 10.1159/000322660. Epub 2010 Nov 26. No abstract available.
- Background: PubMed 22331734Bozkurt Duman B, Kara B, Oguz Kara I, Demiryurek H, Aksungur E. Hand-foot syndrome due to sorafenib in hepatocellular carcinoma treated with vitamin E without dose modification; a preliminary clinical study. J BUON. 2011 Oct-Dec;16(4):759-64.
- Individual participant dataSharing planned: No
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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.
Pei Jye Voon, M.D principal investigator
Sarawak General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moisturising cream with vitamin E concentrate, Moisturising cream without vitamin E concentrate and Urea cream in people with Palmar-Plantar Erythrodysesthesia and Palmar-Plantar Erythrodysesthesia Due to Cytotoxic Therapy, run by Sarawak General Hospital at 1 site in Malaysia.
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 8 inclusion and 11 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: finished, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Palmar-plantar erythrodysesthesia (PPE) resolution (time frame: At Day 22, Day 43, Day 64, and Day 127 of cream treatment). 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 NCT05939726, which also lists 12 linked publications.
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 14 Jan 2026.