Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention

Not Applicable

Completed

• Conditions: Peripheral Neuropathies; Breast Cancer
• Interventions: Other: EOI; Other: Placebo

• Registration Number: NCT03449303
• Lead Sponsor: Augusta University

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-02-28
• Study Start: 2018-06-25
• Primary Completion: 2019-12-30
• Study Completion: 2019-12-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EOI	EOI	10% dilution of Curcuma longa, Piper nigrum, Pelargonium asperum, Zingiber officinale, Mentha x piperita, and Rosmarinus officinalis ct. cineole in Simmondsia chinensis
Placebo	Placebo	Simmondsia chinensis

Primary Outcome Measures

Name	Time	Method
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)	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.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale - Pain (VAS)	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)	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)	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.

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States