Clinical trial NCT03449303: Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention
Official title: Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Peripheral Neuropathies
Keywords: breast cancer
CIPN
Pain
QOL
Essential Oils
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: American Holistic Nurses Association
name: American Nurses Foundation
name: Ananda Apothecary
name: The Jojoba Company
First posted: 2018-02-28
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
timeFrame: baseline and weekly for 6 weeks
Secondary outcomes:
measure: Visual Analogue Scale - Pain (VAS)
timeFrame: Baseline and daily for 6 weeks
measure: Quality of Life Adult Cancer survivor (QLACS)
timeFrame: Baseline, week four and week seven
measure: Quality of Life: Chemotherapy-Induced Peripheral Neuropathy-20 (QOL:CIPN20)
timeFrame: Baseline, week four and week seven
Other outcomes:
measure: Sleep-related questions
timeFrame: Baseline, week four and week seven
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
Study officials:
affiliation: Augusta University
name: Julie K Zadinsky, PhD
role: STUDY_CHAIR
References: