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The Preliminary Effects of Henna on CIPN

NCT ID: NCT04201587

Last Updated: 2019-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-28

Study Completion Date

2019-11-29

Brief Summary

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Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common long-term toxicities of chemotherapy. Though, CIPN is one of the common symptoms encountered by oncology nurses in care of patients. For this reason, there is a need for an intervention that could decrease or prevent of CIPN.

Detailed Description

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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.

Conditions

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Chemotherapy-induced Peripheral Neuropathy

Keywords

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Chemotherapy-induced peripheral neuropathy Henna Nursing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Henna application group

Group Type EXPERIMENTAL

Henna application

Intervention Type OTHER

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).

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Henna application

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Pinar Zorba Bahceli, PhD RN

Asistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Selda Arslan, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Internal Medicine Nursing, Faculty of Nursing, Selcuk University,Konya/Turkey

Locations

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Selcuk University Faculty of Nursing

Konya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2018/78

Identifier Type: -

Identifier Source: org_study_id