Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention (CIPN-EOI)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Peripheral Neuropathies
• Intervention / Treatment: Other: EOI; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: EOI; Topically-applied oil
Placebo Comparator: Placebo; Simmondsia chinensis	Other: Placebo; Topically-applied oil

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep-related questions	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.	Baseline, week four and week seven

Collaborators and Investigators

• Sponsor: Augusta University
• Collaborators: American Holistic Nurses Association; American Nurses Foundation; Ananda Apothecary; The Jojoba Company
• Investigators: Study Chair: Julie K Zadinsky, PhD, Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2018
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2019

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; Pain; QOL; CIPN; Essential Oils
• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Neuromuscular Diseases; Breast Neoplasms; Peripheral Nervous System Diseases
• Other Study ID Numbers: 1028595

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No