The Preliminary Effects of Henna on CIPN

NCT04201587 | Completed

• 1 other identifier: 2018/78
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Peripheral Neuropathy

Keywords

Chemotherapy-induced peripheral neuropathy; Henna; Nursing

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

Study Arms (2)

Henna application group

EXPERIMENTAL

Other: Henna application

Control group

NO INTERVENTION

Interventions

Henna application 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).

Henna application group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University Faculty of Nursing

Konya, 42250, Turkey (Türkiye)

Location

Study Officials

• Selda Arslan, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistant Professor

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 17, 2019
• Study Start: May 28, 2018
• Primary Completion: June 14, 2018
• Study Completion: November 29, 2019
• Last Updated: December 17, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)