Clinical trial NCT04201587: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Peripheral Neuropathy
Keywords: Chemotherapy-induced peripheral neuropathy
Henna
Nursing
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2019-12-17
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Chemotherapy-Induced Peripheral Neuropathy Assessment Tool-CIPNAT
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University Faculty of Nursing
Study officials:
affiliation: Department of Internal Medicine Nursing, Faculty of Nursing, Selcuk University,Konya/Turkey
name: Selda Arslan, PhD
role: PRINCIPAL_INVESTIGATOR
References: