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

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ClinicalTrials.gov Identifier: NCT03449303
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
American Holistic Nurses Association
American Nurses Foundation
Ananda Apothecary
The Jojoba Company
Information provided by (Responsible Party):
Augusta University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Peripheral Neuropathies Other: EOI Other: Placebo Not Applicable

Detailed 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.
Masking: Single (Participant)
Masking Description: 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.
Primary Purpose: Supportive Care
Official Title: Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EOI
10% dilution of Curcuma longa, Piper nigrum, Pelargonium asperum, Zingiber officinale, Mentha x piperita, and Rosmarinus officinalis ct. cineole in Simmondsia chinensis
Other: EOI
Topically-applied oil

Placebo Comparator: Placebo
Simmondsia chinensis
Other: Placebo
Topically-applied oil




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449303


Contacts
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Contact: Dawn L Langley-Brady, PhD(C), MSN 706-721-3998 dlangley@augusta.edu

Locations
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United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Dawn L Langley-Brady, PhD(c), MSN    706-721-3998    dlangley@augusta.edu   
Contact: Julie K Zadinsky, PhD    7067212469    jzadinsky@augusta.edu   
Principal Investigator: Dawn L Langley-Brady, PhD(c), MSN         
Sponsors and Collaborators
Augusta University
American Holistic Nurses Association
American Nurses Foundation
Ananda Apothecary
The Jojoba Company
Investigators
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Study Chair: Julie K Zadinsky, PhD Augusta University

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Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT03449303     History of Changes
Other Study ID Numbers: 1028595
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Augusta University:
breast cancer
CIPN
Pain
QOL
Essential Oils

Additional relevant MeSH terms:
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Breast Neoplasms
Peripheral Nervous System Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neuromuscular Diseases
Nervous System Diseases