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

Augusta University

Status: Completed

Conditions: Breast Cancer; Peripheral Neuropathies

Treatments: Other: EOI; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03449303

1028595

Details and patient eligibility

About

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.

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.

Enrollment: 26 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups, including a placebo group

EOI

Active Comparator group

Description:

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

Treatment:

Other: EOI

Placebo

Placebo Comparator group

Description:

Simmondsia chinensis

Treatment:

Other: Placebo