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NCT Number: NCT03449303

Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Peripheral Neuropathies Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Augusta University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EOI

Other

Topically-applied oil

Placebo

Other

Topically-applied oil

Primary outcomes

  1. Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)

    Time frame: baseline and weekly for 6 weeks

    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.

Secondary outcomes

  1. Visual Analogue Scale - Pain (VAS)

    Time frame: Baseline and daily for 6 weeks

    A 10 cm horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate current pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10. Daily pain scores will be averaged for a weekly mean.

  2. Quality of Life Adult Cancer survivor (QLACS)

    Time frame: Baseline, week four and week seven

    The QLACS consists of 47 questions in two domains (generic and cancer-specific). The questionnaire offers respondents the following choices: 1=never, 2=seldom, 3=sometimes, 4=about as often as not, 5=frequently, 6=very often, and 7=always, yielding a total score of between 0 to 350. A mean score will be used.

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

    Time frame: Baseline, week four and week seven

    The QOL: CIPN20 consists of 20 questions represented by three scales: autonomic symptoms and functioning, sensory, and motor. Participants are to rate symptoms over the past week as 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Items are scored per scale as a higher score = worse, yielding a total score of between 0 and 100. A mean score will be used.

Other outcomes

  1. Sleep-related questions

    Time frame: Baseline, week four and week seven

    The following two questions are exploratory: In the past seven days, how many times have you slept through the night? In the past seven days, how many times did your pain wake you from sleep? If pain woke you from sleep, please describe your experience. If anything other than pain woke you from sleep, please list. Neither QOL questionnaire also address sleep. The answers to these questions will be integrated into QOL data.

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • American Holistic Nurses Association
  • American Nurses Foundation
  • Ananda Apothecary
  • The Jojoba Company

Registry information

Official study title

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

Acronym: CIPN-EOI

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 28, 2018
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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