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Trial record 8 of 13 for:    1,8-cineole

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

Tracking Information
First Submitted Date  ICMJE January 8, 2018
First Posted Date  ICMJE February 28, 2018
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE June 25, 2018
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03449303 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 22, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention
Official Title  ICMJE Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Breast Cancer
  • Peripheral Neuropathies
Intervention  ICMJE
  • Other: EOI
    Topically-applied oil
  • Other: Placebo
    Topically-applied oil
Study Arms  ICMJE
  • 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
    Intervention: Other: EOI
  • Placebo Comparator: Placebo
    Simmondsia chinensis
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 22, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dawn L Langley-Brady, PhD(C), MSN 706-721-3998 dlangley@augusta.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03449303
Other Study ID Numbers  ICMJE 1028595
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Augusta University
Study Sponsor  ICMJE Augusta University
Collaborators  ICMJE
  • American Holistic Nurses Association
  • American Nurses Foundation
  • Ananda Apothecary
  • The Jojoba Company
Investigators  ICMJE
Study Chair: Julie K Zadinsky, PhD Augusta University
PRS Account Augusta University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP