Clinical TrialID 1252

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

NCT05429814

Breast Cancer|Peripheral Neuropathies|Chemotherapy Effect

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Record Fields

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Clinical Trial Id
1252
Evidence Id
1252
Core Evidence Id
1252
Source Clinical Trial Id
1235
Herb2 Clinical Trial Id
HBCT001235
Nct Id
NCT05429814
Title
Topical Menthol Application in Chemotherapy-Related Peripheral Neuropathy in Patients With Breast Cancer
Status
Completed
Phase
Study Result
No
Study Condition
Breast Cancer|Peripheral Neuropathies|Chemotherapy Effect
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Intervention
OTHER: Menthol Application
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Double
Intervention Purpose
Supportive_Care
Gender
Female
Age
Adult, Older_Adult
Enrollment
60
Outcome Measure
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
Sponsor Collaborator
Necmettin Erbakan University
Funded By
OTHER
Location
Necmettin Erbakan University, Konya, Meram, 42090, Turkey
Other Id
21129002
Start Date
2022-07-01
Primary Completion Date
2023-03-22
Completion Date
2023-04-01
First Posted
2022-06-23
Results First Posted
Last Update Posted
2023-04-04
Study Document
Study Url
https://clinicaltrials.gov/study/NCT05429814
Title Cn
Title En
Topical Menthol Application in Chemotherapy-Related Peripheral Neuropathy in Patients With Breast Cancer
Bilingual Status
semi_complete