Topical Menthol Application in Chemotherapy-Related Peripheral Neuropathy in Patients With Breast Cancer

NCT05429814 | Completed DMC

• 1 other identifier: 21129002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Peripheral neuropathy resulting from chemotherapy is a problem that concerns not only the individual but also their relatives and all healthcare personnel responsible for care. Studies to be carried out in this area are important in terms of providing evidence for nurses' practices and supporting the individual by alleviating the symptoms of the disease. Based on this information, the aim of this study is to determine the effect of menthol application, which will be applied to the hands and feet of breast cancer patients receiving chemotherapy, on CIPN.

Conditions

Breast Cancer; Peripheral Neuropathies; Chemotherapy Effect

Keywords

Breast Cancer; Peripheral neuropathy; Menthol; Chemotherapy

Outcome Measures

Primary Outcomes (2)

• Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)

  The first section assesses the nine main symptoms as well as their severity, the extent to which they cause emotional disruption, and the frequency of their occurrence. The first six items in this section are related to sensory symptoms, while the seventh, eighth and ninth items are related to sub-dimensions of motor symptoms. In the second part, 14 activities were evaluated and questions were asked about the effect level of these substances. The activities assessed included fine motor and general activities. To assess the symptoms listed in the first section, "Yes" was considered equal to 1 point and "No" equal to 0 (0-9); their severity, symptoms, extent and frequency of emotional impairment were scored between 0 and 10 (0-270). The total score for the first part of the instrument is between 0 and 279. The effect level on the 14 activities in the second part was calculated between 0 and 10 (0-140). The Cronbach's alpha value of the original scale is 0.95

  3 weeks after the first assessment

• Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)

  The first section assesses the nine main symptoms as well as their severity, the extent to which they cause emotional disruption, and the frequency of their occurrence. The first six items in this section are related to sensory symptoms, while the seventh, eighth and ninth items are related to sub-dimensions of motor symptoms. In the second part, 14 activities were evaluated and questions were asked about the effect level of these substances. The activities assessed included fine motor and general activities. To assess the symptoms listed in the first section, "Yes" was considered equal to 1 point and "No" equal to 0 (0-9); their severity, symptoms, extent and frequency of emotional impairment were scored between 0 and 10 (0-270). The total score for the first part of the instrument is between 0 and 279. The effect level on the 14 activities in the second part was calculated between 0 and 10 (0-140). The Cronbach's alpha value of the original scale is 0.95

  6 weeks after the first assessment

Study Arms (2)

Experimental

EXPERIMENTAL

During the study, the patients' routine pharmacological treatments will continue and menthol will be applied only to reduce the effect of neuropathy. In the study, menthol 1% will be used topically, as it was used in studies after the literature review. Although it was stated in the studies that menthol had no side effects, it was decided to mix menthol with water-based cream according to the literature recommendation. Researchers will first determine how many grams of menthol will be sufficient by applying menthol to their hands and feet.After the gram of the prepared mixture is determined, it will be given to the patients. Patients in the intervention group will be taught how to regularly apply menthol cream (topical menthol) to their hands and feet, twice a day, every day. The effect on CIPN will be evaluated in patients with CIPN for 3 weeks immediately before and after 6 weeks of treatment with menthol administration.

Other: Menthol Application

control group

NO INTERVENTION

control group will receive standard practice

Interventions

Menthol Application OTHER

During the study, the patients' routine pharmacological treatments will continue and menthol will be applied only to reduce the effect of neuropathy. In the study, menthol 1% will be used topically, as it was used in studies after the literature review. Although it was stated in the studies that menthol had no side effects, it was decided to mix menthol with water-based cream according to the literature recommendation. Researchers will first determine how many grams of menthol will be sufficient by applying menthol to their hands and feet.After the gram of the prepared mixture is determined, it will be given to the patients. Patients in the intervention group will be taught how to regularly apply menthol cream (topical menthol) to their hands and feet, twice a day, every day. The effect on CIPN will be evaluated in patients with CIPN for 3 weeks immediately before and after 6 weeks of treatment with menthol administration.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who received at least two cycles of chemotherapy
• Patients aged 18 and over
• Women who received the paclitaxel chemotherapy protocol will be included.

You may not qualify if:

• Those with open wounds and edema on their hands and feet
• Patients with diabetes mellitus and peripheral neuropathy due to autoimmune disease
• Use complementary and alternative treatment methods to prevent peripheral neuropathy throughout the treatment process.
• Those who are allergic to topical menthol to be used in the study will be excluded from the study.

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (1)

• Ozdemir D, Arslan S, Artac M, Karaarslan F. Topical menthol for chemotherapy-induced peripheral neuropathy: a randomised controlled trial in breast cancer. BMJ Support Palliat Care. 2024 Dec 25;15(1):79-86. doi: 10.1136/spcare-2023-004483.

  PMID: 39038990 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Selda Arslan, Phd

  Necmettin Erbakan University Faculty of Nursing

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Parallel Assignment prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: June 11, 2022
• First Posted: June 23, 2022
• Study Start: July 1, 2022
• Primary Completion: March 22, 2023
• Study Completion: April 1, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)