Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention (CIPN-EOI)
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|ClinicalTrials.gov Identifier: NCT03449303|
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : June 29, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Peripheral Neuropathies||Other: EOI Other: Placebo||Not Applicable|
Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, debilitating consequence of cancer treatment and is considered the most adverse of non-hematologic events. Current pharmacological approaches to reduce CIPN symptoms can be ineffective and cause adverse effects.
Constituents of this oil blend moderate pain signal transmission through non-competing inhibition of 5-HT, AchE, and Substance P, along with antagonism of TRPA1 and TRPV1. This study will test the hypothesis that an oil blend reduces CIPN symptoms and improves quality-of-life (QOL) in breast cancer patients. The Human Response to Illness model is used to underpin a convergent-nested-parallel mixed-methods design with intervention.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.|
|Masking Description:||Participants will be seen in two separate clinic rooms. Intervention and placebo will have identical packaging and labeling with the addition of an A or B.|
|Primary Purpose:||Supportive Care|
|Official Title:||Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study|
|Actual Study Start Date :||June 25, 2018|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||April 30, 2019|
Active Comparator: EOI
10% dilution of Curcuma longa, Piper nigrum, Pelargonium asperum, Zingiber officinale, Mentha x piperita, and Rosmarinus officinalis ct. cineole in Simmondsia chinensis
Placebo Comparator: Placebo
- Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) [ Time Frame: baseline and weekly for 6 weeks ]A 22-item self-report pain intensity (over past week) peripheral neuropathy questionnaire. Each item is scored from 0 -10 (0 is no pain and 10 is the worst possible pain), a mean score is obtained, yielding a mean score between 0 and 10.
- Visual Analogue Scale - Pain (VAS) [ Time Frame: Baseline and daily for 6 weeks ]A 10 cm horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate current pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10. Daily pain scores will be averaged for a weekly mean.
- Quality of Life Adult Cancer survivor (QLACS) [ Time Frame: Baseline, week four and week seven ]The QLACS consists of 47 questions in two domains (generic and cancer-specific). The questionnaire offers respondents the following choices: 1=never, 2=seldom, 3=sometimes, 4=about as often as not, 5=frequently, 6=very often, and 7=always, yielding a total score of between 0 to 350. A mean score will be used.
- Quality of Life: Chemotherapy-Induced Peripheral Neuropathy-20 (QOL:CIPN20) [ Time Frame: Baseline, week four and week seven ]The QOL: CIPN20 consists of 20 questions represented by three scales: autonomic symptoms and functioning, sensory, and motor. Participants are to rate symptoms over the past week as 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Items are scored per scale as a higher score = worse, yielding a total score of between 0 and 100. A mean score will be used.
- Sleep-related questions [ Time Frame: Baseline, week four and week seven ]The following two questions are exploratory: In the past seven days, how many times have you slept through the night? In the past seven days, how many times did your pain wake you from sleep? If pain woke you from sleep, please describe your experience. If anything other than pain woke you from sleep, please list. Neither QOL questionnaire also address sleep. The answers to these questions will be integrated into QOL data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449303
|Contact: Dawn L Langley-Brady, PhD(C), MSNfirstname.lastname@example.org|
|United States, Georgia|
|Augusta, Georgia, United States, 30912|
|Contact: Dawn L Langley-Brady, PhD(c), MSN 706-721-3998 email@example.com|
|Contact: Julie K Zadinsky, PhD 7067212469 firstname.lastname@example.org|
|Principal Investigator: Dawn L Langley-Brady, PhD(c), MSN|
|Study Chair:||Julie K Zadinsky, PhD||Augusta University|