The Preliminary Effects of Henna on CIPN

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.

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Selcuk University Faculty of Nursing

Konya, 42250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

Chemotherapy-Induced Peripheral Neuropathy Assessment Tool-CIPNAT

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.

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.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

The Preliminary Effects of Henna on Chemotherapy-Induced Peripheral Neuropathy in Women Receiving Oxaliplatin Based Treatment: A Parallel Group Randomized Controlled Pilot Trial

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Dec 17, 2019
Registry last updated: Dec 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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