The Preliminary Effects of Henna on CIPN
Кључне речи
Апстрактан
Опис
Chemotherapy-induced peripheral neuropathy (CIPN) is frequently seen in patients receiving oxaliplatin-based therapy.This parallel group randomized controlled pilot clinical trial aimed at investigating the feasibility and preliminary effect of henna on CIPN in women receiving oxaliplatin-based therapy. This trial was conducted in the chemotherapy outpatient clinic of University Hospital located in Turkey. All patients were women who received oxaliplatin-based therapy in the oncology clinic every fifteen days.
In order to calculate the sample size, it was decided to recruit 30 female patients to each group (intervention and control) using the G.Power-3.1.9.2 program. A total of 60 female patients were included in the study.
The study consists of two groups. In the intervention group, after the 2nd and 3rd chemotherapy cycles, henna application was applied to the hand-foot and toes. The control group underwent only the routine treatment.
To collect data, a personal information form and Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) were used.
Датуми
| Последња верификација: | 11/30/2019 |
| Фирст Субмиттед: | 12/11/2019 |
| Предвиђена пријава послата: | 12/15/2019 |
| Прво објављено: | 12/16/2019 |
| Послато последње ажурирање: | 12/15/2019 |
| Последње ажурирање објављено: | 12/16/2019 |
| Стварни датум почетка студије: | 05/27/2018 |
| Процењени датум примарног завршетка: | 06/13/2018 |
| Предвиђени датум завршетка студије: | 11/28/2019 |
Стање или болест
Интервенција / лечење
Other: Henna application group
Фаза
Групе руку
| Арм | Интервенција / лечење |
|---|---|
| Experimental: Henna application group | Other: Henna application group Henna application was performed to the patients in the intervention group. The patient was instructed to apply henna before going to bed at night, and after waking up in the morning (for an average of 8-10 hours) was instructed to wash with only water. The patient was asked to do this application at home after the second and third chemotherapy cycles. Thus, the patient applied henna twice in total (fifteen days apart). |
| No Intervention: Control group |
Критеријуми
| Узраст подобан за студирање | 18 Years До 18 Years |
| Полови подобни за студирање | Female |
| Прихвата здраве волонтере | да |
| Критеријуми | Inclusion Criteria: - 18 years and older women - Must the level of neurotoxicity is Stage II and Stage III - Must taken at least one chemotherapy cycle and is planned to continue 2 chemotherapy cycles - Be taking Folfox-6 chemotherapy protocol Exclusion Criteria: - Having an open wound and edema in the hands and feet - Having a peripheral neuropathy due to diabetes and autoimmune diseases - Using any complementary and alternative (CAM) treatment method to prevent peripheral neuropathy during administration |
Исход
Примарне мере исхода
1. Chemotherapy-Induced Peripheral Neuropathy Assessment Tool-CIPNAT [It was filled before the 2nd, 3rd and 4th chemotherapy cycles (each cycle is 15 days). Change from baseline Chemotherapy-Induced Peripheral Neuropathy Assessment Tool scores at 6 weeks.]
