Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention

Study Overview
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Brief Summary
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This study will evaluate an oil blend with active ingredients for the reduction in chemotherapy-induced peripheral neuropathy in people with breast cancer. Half of the participants will receive the oil blend with active ingredients and the other half will receive a placebo (an oil blend with no active ingredients). One-fourth of the people will also take pictures of their life with chemotherapy-induced peripheral neuropathy.

Detailed Description
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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.

Official Title
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Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study

Conditions
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Breast Cancer, Peripheral Neuropathies

Intervention / Treatment
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* Other: EOI
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of breast cancer chronic CIPN symptoms in one or both lower extremities three months or greater since last chemotherapy treatment mean SF-MPQ-2 score of greater than or equal to three a prognosis of greater than six months Exclusion Criteria: non-English-speaking blindness pregnancy breastfeeding allergy to EOI or Peru balsam (cross-allergen) illegal substance usage history of severe skin reactions non-intact skin on lower extremities history of lower extremity trauma or amputation current use of aromatherapy/Essential Oils asthma or reactive airway disease triggered by constituents of EOI history of mental illness or chronic depression the following co-morbidities: G6PD deficiency, inherited peripheral neuropathy, active herpes varicella-zoster, herpes simplex virus, alcoholic neuropathy, repetitive stress or entrapment neuropathy, peripheral vascular disease, and multifocal mononeuropathy.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EOI<br>10% dilution of Curcuma longa, Piper nigrum, Pelargonium asperum, Zingiber officinale, Mentha x piperita, and Rosmarinus officinalis ct. cineole in Simmondsia chinensis | Other: EOI<br>* Topically-applied oil<br>|
| Placebo Comparator: Placebo<br>Simmondsia chinensis | Other: Placebo<br>* Topically-applied oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) | 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. | baseline and weekly for 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale - Pain (VAS) | 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. | Baseline and daily for 6 weeks | 
| Quality of Life Adult Cancer survivor (QLACS) | 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. | Baseline, week four and week seven | 
| Quality of Life: Chemotherapy-Induced Peripheral Neuropathy-20 (QOL:CIPN20) | 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. | Baseline, week four and week seven | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, CIPN, Pain, QOL, Essential Oils