The Preliminary Effects of Henna on CIPN

Selcuk University

Status: Completed

Conditions: Chemotherapy-induced Peripheral Neuropathy

Treatments: Other: Henna application

Study type: Interventional

Funder types: Other

Identifiers

NCT04201587

2018/78

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Henna application group

Experimental group

Treatment:

Other: Henna application

Control group

No Intervention group