Breast CancerNCT05429814
Topical Menthol Application in Chemotherapy-Related Peripheral Neuropathy in Patients With Breast Cancer
A study testing Menthol Application in people with Breast Cancer and Peripheral Neuropathies, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Peripheral Neuropathies, Chemotherapy Effect
- What is being tested?
- Menthol Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who received at least two cycles of chemotherapy
- Patients aged 18 and over
- Women who received the paclitaxel chemotherapy protocol will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University
Konya, Meram, 42090
About this study
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.
Read the detailed description
Introduction and Aim: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common side effects of chemotherapeutic agents. CIPN is a frequently dose-limiting neurotoxicity that causes significant deterioration in patients' quality of life. CIPN mainly plays a role in sensory peripheral neuropathy, although some patients have motor symptoms such as weakness and autonomic neuropathy. Sensory neuropathy is often distributed in the form of socks and gloves, causing symptoms such as spontaneous pain, allodynia, hyperalgesia, hypoesthesia, pins and needles, numbness, paresthesia, tingling, and gait disturbance. Treatment of CIPN requires non-toxic therapies as most of the pharmacological treatments for neuropathic pain, including antidepressants and anticonvulsants, have toxic side effects. Patients seek supportive strategies in the management of CIPN. There are a limited number of studies on non-pharmacological methods such as cryotherapy, massage, acupuncture, henna on hands and feet used in the management of peripheral neuropathy. Menthol has been widely used in traditional medicine as a topical pain reliever since ancient times. Creams containing menthol are available in the form of liquid, gel or lotion. Menthol-containing products that have not been studied in CIPN management are used in patients with a wide variety of ailments, including muscle pain, back, joint pain, and management of arthritis-related pain. Recent advances in the pathophysiology of pain have revealed new pathways responsible for the analgesic effect of menthol. Therefore, it is very important to determine the basic science and clinical efficacy data on the pain-relieving and cooling properties of menthol. Menthol (mint camphor) is an essential oil extract obtained from the genus Mentha (mint). Oncology clinical practice guidelines (ESMO; EONS; EANO) used for the diagnosis, prevention, treatment and follow-up of peripheral neurotoxicity caused by systemic anticancer therapy recommend menthol as a local intervention. Although these guidelines recommend menthol application, no studies have been found in the national and international literature showing the effect of topical menthol application in chemotherapy-induced peripheral neuropathy in patients with breast cancer. 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 on CIPN, which will be applied to the hands and feet of breast cancer patients receiving chemotherapy.
Method: The project was planned as a prospective, single-blind, randomized controlled experimental type.
The research will be carried out in Konya Necmettin Erbakan University Meram Medical Faculty Hospital Oncology Department between November 2021 and November 2022. In determining the sample size, based on the studies in the literature, the minimum number of samples was determined as 60, 30 in each group, with 95% confidence, 80% test power, and considering possible losses. Questionnaire Form, Chemotherapy-Induced Peripheral Neuropathy Evaluation Tool (CIPNAT) will be used as data collection tools.
Management: Data will be collected by the assistant researcher at the beginning of the study, at 3 weeks and at 6 weeks, in the doctor's room in the Oncology building of Necmettin Erbakan University Meram Medical Faculty Hospital. In the preliminary application of the study, a questionnaire will be applied to 10 patients.
Menthol Application 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.
Widespread effect: Studies have shown that topical menthol application reduces chemotherapy-induced peripheral neuropathy. It has been determined that 1% menthol cream, which is applied to the hands and feet twice a day, reduces the severity of neuropathy symptoms and reduces neuropathy pain. This study will contribute to the literature and will have a significant impact on the quality of life of many cancer patients and cancer survivors.
- Conditions
- Breast Cancer, Peripheral Neuropathies, Chemotherapy Effect
- Being tested
- Menthol Application
- Keywords
- Breast Cancer, Peripheral neuropathy, Menthol, Chemotherapy
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Menthol Application |
| control group | No intervention | control group will receive standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 weeks after the first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start1 Jul 2022
- Primary completion22 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment prospective randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Ozdemir, Necmettin Erbakan University
- Investigators
- Selda Arslan, Phd, Study director, Necmettin Erbakan University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05429814
- Sponsor's protocol ID
- 21129002
- Status last verified
- Apr 2023
- First submitted
- 11 Jun 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39038990
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Menthol Application in Chemotherapy-Related Peripheral Neuropathy in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT05429814
- Acronym / sponsor ID
- 21129002
- Conditions
- Breast Cancer, Peripheral Neuropathies, Chemotherapy Effect
- Keywords
- Breast Cancer, Peripheral neuropathy, Menthol, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction and Aim: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common side effects of chemotherapeutic agents. CIPN is a frequently dose-limiting neurotoxicity that causes significant deterioration in patients' quality of life. CIPN mainly plays a role in sensory peripheral neuropathy, although some patients have motor symptoms such as weakness and autonomic neuropathy. Sensory neuropathy is often distributed in the form of socks and gloves, causing symptoms such as spontaneous pain, allodynia, hyperalgesia, hypoesthesia, pins and needles, numbness, paresthesia, tingling, and gait disturbance. Treatment of CIPN requires non-toxic therapies as most of the pharmacological treatments for neuropathic pain, including antidepressants and anticonvulsants, have toxic side effects. Patients seek supportive strategies in the management of CIPN. There are a limited number of studies on non-pharmacological methods such as cryotherapy, massage, acupuncture, henna on hands and feet used in the management of peripheral neuropathy. Menthol has been widely used in traditional medicine as a topical pain reliever since ancient times. Creams containing menthol are available in the form of liquid, gel or lotion. Menthol-containing products that have not been studied in CIPN management are used in patients with a wide variety of ailments, including muscle pain, back, joint pain, and management of arthritis-related pain. Recent advances in the pathophysiology of pain have revealed new pathways responsible for the analgesic effect of menthol. Therefore, it is very important to determine the basic science and clinical efficacy data on the pain-relieving and cooling properties of menthol. Menthol (mint camphor) is an essential oil extract obtained from the genus Mentha (mint). Oncology clinical practice guidelines (ESMO; EONS; EANO) used for the diagnosis, prevention, treatment and follow-up of peripheral neurotoxicity caused by systemic anticancer therapy recommend menthol as a local intervention. Although these guidelines recommend menthol application, no studies have been found in the national and international literature showing the effect of topical menthol application in chemotherapy-induced peripheral neuropathy in patients with breast cancer. 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 on CIPN, which will be applied to the hands and feet of breast cancer patients receiving chemotherapy.
Method: The project was planned as a prospective, single-blind, randomized controlled experimental type.
The research will be carried out in Konya Necmettin Erbakan University Meram Medical Faculty Hospital Oncology Department between November 2021 and November 2022. In determining the sample size, based on the studies in the literature, the minimum number of samples was determined as 60, 30 in each group, with 95% confidence, 80% test power, and considering possible losses. Questionnaire Form, Chemotherapy-Induced Peripheral Neuropathy Evaluation Tool (CIPNAT) will be used as data collection tools.
Management: Data will be collected by the assistant researcher at the beginning of the study, at 3 weeks and at 6 weeks, in the doctor's room in the Oncology building of Necmettin Erbakan University Meram Medical Faculty Hospital. In the preliminary application of the study, a questionnaire will be applied to 10 patients.
Menthol Application 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.
Widespread effect: Studies have shown that topical menthol application reduces chemotherapy-induced peripheral neuropathy. It has been determined that 1% menthol cream, which is applied to the hands and feet twice a day, reduces the severity of neuropathy symptoms and reduces neuropathy pain. This study will contribute to the literature and will have a significant impact on the quality of life of many cancer patients and cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment prospective randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Menthol ApplicationDuring 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. |
| control group | No intervention | –control group will receive standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who received at least two cycles of chemotherapy
- Patients aged 18 and over
- Women who received the paclitaxel chemotherapy protocol will be included.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menthol ApplicationDuring 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 | Experimental |
Primary outcome
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
Time frame: 3 weeks after the first assessment
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
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT)
Time frame: 6 weeks after the first assessment
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Derived from this study: PubMed 39038990Ozdemir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selda Arslan, Phd study director
Necmettin Erbakan University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol Application in people with Breast Cancer and Peripheral Neuropathies, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemotherapy-Induced Peripheral Neuropathy Assessment Tool (CIPNAT) (time frame: 3 weeks after the first assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05429814, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.