Breast Cancer Clinical Trial

Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention

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.

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Full 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.

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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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

26

Study ID:

NCT03449303

Recruitment Status:

Completed

Sponsor:

Augusta University

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There is 1 Location for this study

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Augusta University
Augusta Georgia, 30912, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

26

Study ID:

NCT03449303

Recruitment Status:

Completed

Sponsor:


Augusta University

How clear is this clinincal trial information?

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