Trial | NCT03449303  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    26
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.
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 Started
Jun 25
2018
Primary Completion
Dec 30
2019
Study Completion
Dec 30
2019
Last Update
Nov 02
2020

Other Placebo

Topically-applied oil

EOI Active Comparator

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

Placebo Placebo Comparator

Simmondsia chinensis

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.
No Results Posted