Testing the Effectiveness of Henna on Managing PPE
Кључне речи
Апстрактан
Опис
This will be a randomized double-blind, placebo-controlled study with 80 cancer patients that will receive chemotherapy treatment with capecitabine and/or pegylated liposomal doxorubicin. The selection of potential participants will be based on pre-determined inclusion and exclusion criteria. Patients will be randomly allocated either to the treatment group or the placebo group. Treatment will be delivered twice a week and assessments will take place at 2, 3, 4, 5 and 6 weeks.
The intervention group will receive the application of henna 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.
Датуми
| Последња верификација: | 09/30/2019 |
| Фирст Субмиттед: | 12/13/2012 |
| Предвиђена пријава послата: | 12/16/2012 |
| Прво објављено: | 12/17/2012 |
| Послато последње ажурирање: | 10/22/2019 |
| Последње ажурирање објављено: | 10/24/2019 |
| Стварни датум почетка студије: | 05/31/2017 |
| Процењени датум примарног завршетка: | 04/30/2018 |
| Предвиђени датум завршетка студије: | 06/14/2018 |
Стање или болест
Интервенција / лечење
Drug: Henna arm
Drug: Placebo
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Experimental: Henna arm Based on the treatment protocol for this study the patients will receive the henna treatment for 4 weeks (supervised treatment for first week and then unsupervised sessions twice a week). The treatment will include the application of the henna mixture (paste) (40gr natural henna and 40ml of purified water) to the affected areas (feet or/and hands) and wear socks or/and gloves. The treatment session will last for 1 hour and then the mixture will be rinsed with fresh water. | Drug: Henna arm natural henna in the form of paste |
| Placebo Comparator: Placebo Based on the treatment protocol for this study the patients in this arm will receive the henna placebo treatment for 4 weeks (supervised treatment for first week and then unsupervised sessions twice a week). The treatment will include the application of the henna placebo mixture (paste) (40gr placebo henna and 40ml of purified water) to the affected areas (feet or/and hands) and wear socks or/and gloves. The treatment session will last for 1 hours and then the mixture will be rinsed with fresh water. | Drug: Placebo placebo |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | All |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: - Adult cancer patients (>18) - Patients receiving capecitabine and/or PLD as monotherapy or in combination with other agents - Patients that will experience PPE grade 1 or above - Willing to participate - Ability to complete the psychometric assessments. - A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG) Exclusion Criteria: - Patients with hypersensitivity to natural henna. - Patients with pre-existing dermatological condition affecting the hands or feet that may limit the interpretation of results - Patients on Pyridoxine or nicotine patches - Patients with a previous history of PPE - Patients whose chemotherapy was discontinued for more than a week |
Исход
Примарне мере исхода
1. Change from Baseline PPE Grade at 3,4, 5,6 weeks [3, 4, 5 and 6 weeks]
Секундарне мере исхода
1. Change from Baseline EORTC QOLc30 at 3,4, 5,6 weeks [3, 4,5 and 6 weeks]
2. Change from Baseline Hand-foot syndrome 14 (HFS-14) at 3,4,5,6 weeks [3, 4, 5 and 6 weeks]
Остале мере исхода
1. Change from Baseline Activities of daily living at 3,4,5,6 weeks [3, 4, 5 and 6 weeks]
2. Treatment side-effects [During the 4 weeks]
