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| Name | Class |
|---|---|
| American Medical Center | OTHER |
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The study is designed to test the effectiveness of topical B6 cream in patients that developed Palmar-Plantar Erythrodysesthesia (Hand foot syndrome).
This will be a randomized double-blind, placebo-controlled study with 100 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered daily (t.d.s) and assessments will take place at 0, 1, 2, 3 and 4 weeks.
The intervention group will receive the application of topical vitamin B6 cream to the hands and/or feet of the patients and the control group will receive the placebo.
At both baseline and follow-up, patients in both groups will be assessed for their degree of palmar-plantar erythrodysesthesia, the Quality of Life, the need for dose-limiting due to PPE and Pain intensity using standardized rating scales. Data will be analysed with inferential and descriptive statistics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin B6 | Experimental | Topical application of B6 cream to the hand or/and feet 1-2 ml applied to the hand or /and feet three times a day for 4 weeks. |
|
| Placebo | Placebo Comparator | Topical application of B6 Placebo cream to the hand or/and feet 1-2 ml applied to the hand or /and feet three times a day for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin B6 cream | Device | Topical Vitamin B6 cream |
| |
| Placebo Vitamin B6 cream |
| Measure | Description | Time Frame |
|---|---|---|
| PPE grade | The grade of PPE will be assessed with a standardised three-grade system previously used in capecitabine clinical trials (Scheithauer et al 2003) | up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life | The HRQoL of the patients will be assessed with the EORTC QLQ -C30 module which has been developed and validated explicitly for patients suffering from cancer. | up to 4 weeks |
| Quality of Life in relation to PPE |
| Measure | Description | Time Frame |
|---|---|---|
| Activities of daily living | Activities of daily living will be assessed with the Eastern Co-operative Oncology Group (ECOG)/WHO system | up to 4 weeks |
| Treatment side-effects | Any possible side-effect due to the treatment will be recorded |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limassol General Hospital | Limassol | Cyprus | ||||
| American Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33227569 | Derived | Charalambous A, Tsitsi T, Astras G, Paikousis L, Filippou E. A pilot randomized double-blind, placebo-controlled study on the effects of the topical application of pyridoxine on palmar-plantar erythrodysesthesia (PPE) induced by capecitabine or pegylated liposomal doxorubicin (PLD). Eur J Oncol Nurs. 2021 Feb;50:101866. doi: 10.1016/j.ejon.2020.101866. Epub 2020 Nov 11. |
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| ID | Term |
|---|---|
| D060831 | Hand-Foot Syndrome |
| ID | Term |
|---|---|
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Device |
Placebo Vitamin B6 cream |
|
This is a quality of life scale specifically for patients experiencing radiation-induced PPE
| up to 4 weeks |
| up to 4 weeks |
| Nicosia |
| 1311 |
| Cyprus |
| D004342 |
| Drug Hypersensitivity |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |