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Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention

NCT ID: NCT03449303

Last Updated: 2020-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-25

Study Completion Date

2019-12-30

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.

Conditions

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Breast Cancer Peripheral Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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EOI

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

Group Type ACTIVE_COMPARATOR

EOI

Intervention Type OTHER

Topically-applied oil

Placebo

Simmondsia chinensis

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Topically-applied oil

Interventions

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EOI

Topically-applied oil

Intervention Type OTHER

Placebo

Topically-applied oil

Intervention Type OTHER

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Holistic Nurses Association

UNKNOWN

Sponsor Role collaborator

American Nurses Foundation

OTHER

Sponsor Role collaborator

Ananda Apothecary

UNKNOWN

Sponsor Role collaborator

The Jojoba Company

UNKNOWN

Sponsor Role collaborator

Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie K Zadinsky, PhD

Role: STUDY_CHAIR

Augusta University

Locations

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Augusta University

Augusta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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1028595

Identifier Type: -

Identifier Source: org_study_id