Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention

NCT03449303 | Completed

• 1 other identifier: 1028595
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Peripheral Neuropathies

Keywords

breast cancer; CIPN; Pain; QOL; Essential Oils

Outcome Measures

Primary Outcomes (1)

• Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)

  A 22-item self-report pain intensity (over past week) peripheral neuropathy questionnaire. Each item is scored from 0 -10 (0 is no pain and 10 is the worst possible pain), a mean score is obtained, yielding a mean score between 0 and 10.

  baseline and weekly for 6 weeks

Secondary Outcomes (3)

• Visual Analogue Scale - Pain (VAS)

  Baseline and daily for 6 weeks

• Quality of Life Adult Cancer survivor (QLACS)

  Baseline, week four and week seven

• Quality of Life: Chemotherapy-Induced Peripheral Neuropathy-20 (QOL:CIPN20)

  Baseline, week four and week seven

Other Outcomes (1)

• Sleep-related questions

  Baseline, week four and week seven

Study Arms (2)

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

Other: EOI

Placebo

PLACEBO COMPARATOR

Simmondsia chinensis

Other: Placebo

Interventions

EOI OTHER

Topically-applied oil

EOI

Placebo OTHER

Topically-applied oil

Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Augusta University: lead
• American Holistic Nurses Association: collaborator
• American Nurses Foundation: collaborator
• Ananda Apothecary: collaborator
• The Jojoba Company: collaborator

Study Sites (1)

Augusta University

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases; Pain

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Julie K Zadinsky, PhD

  Augusta University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: January 8, 2018
• First Posted: February 28, 2018
• Study Start: June 25, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)