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The Preliminary Effects of Henna on CIPN

Primary Purpose

Chemotherapy-induced Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Henna application
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Peripheral Neuropathy focused on measuring Chemotherapy-induced peripheral neuropathy, Henna, Nursing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Selcuk University Faculty of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Henna application group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Chemotherapy-Induced Peripheral Neuropathy Assessment Tool-CIPNAT
It was developed by Tofthagen et al. (2011) to evaluate chemotherapy-induced peripheral neuropathy. It consists of two sections. The first section concerns nine symptoms; the severity of these symptoms, the possibility of an emotional problem occurring, and the incidence rate of these symptoms are evaluated. The first six questions in this section constitute the sensory symptoms, and the seventh, eighth and ninth questions constitute the subdimensions of motor symptoms. In the second section, fourteen (sensory and motor) activities were evaluated, including whether they were affected by the symptoms. The total score to be obtained from the scale is between 0 and 279. High scores indicate severe symptoms, high rate of incidence, many emotional problems and limitations on daily life activities.It was tested for validity and reliability on Turkish population by Kutluturkan et al. (2017), with Cronbach's alpha reliability coefficient of 0.95.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2019
Last Updated
December 16, 2019
Sponsor
Selcuk University
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1. Study Identification

Unique Protocol Identification Number
NCT04201587
Brief Title
The Preliminary Effects of Henna on CIPN
Official Title
The Preliminary Effects of Henna on Chemotherapy-Induced Peripheral Neuropathy in Women Receiving Oxaliplatin Based Treatment: A Parallel Group Randomized Controlled Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
June 14, 2018 (Actual)
Study Completion Date
November 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Selcuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Peripheral Neuropathy
Keywords
Chemotherapy-induced peripheral neuropathy, Henna, Nursing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Henna application group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Henna application
Intervention Description
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).
Primary Outcome Measure Information:
Title
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool-CIPNAT
Description
It was developed by Tofthagen et al. (2011) to evaluate chemotherapy-induced peripheral neuropathy. It consists of two sections. The first section concerns nine symptoms; the severity of these symptoms, the possibility of an emotional problem occurring, and the incidence rate of these symptoms are evaluated. The first six questions in this section constitute the sensory symptoms, and the seventh, eighth and ninth questions constitute the subdimensions of motor symptoms. In the second section, fourteen (sensory and motor) activities were evaluated, including whether they were affected by the symptoms. The total score to be obtained from the scale is between 0 and 279. High scores indicate severe symptoms, high rate of incidence, many emotional problems and limitations on daily life activities.It was tested for validity and reliability on Turkish population by Kutluturkan et al. (2017), with Cronbach's alpha reliability coefficient of 0.95.
Time Frame
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.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selda Arslan, PhD
Organizational Affiliation
Department of Internal Medicine Nursing, Faculty of Nursing, Selcuk University,Konya/Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Selcuk University Faculty of Nursing
City
Konya
ZIP/Postal Code
42250
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Preliminary Effects of Henna on CIPN

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