Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention (CIPN-EOI)
Primary Purpose
Breast Cancer, Peripheral Neuropathies
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EOI
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, CIPN, Pain, QOL, Essential Oils
Eligibility 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.
Sites / Locations
- Augusta University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
EOI
Placebo
Arm Description
10% dilution of Curcuma longa, Piper nigrum, Pelargonium asperum, Zingiber officinale, Mentha x piperita, and Rosmarinus officinalis ct. cineole in Simmondsia chinensis
Simmondsia chinensis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Visual Analogue Scale - Pain (VAS)
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)
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)
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.
Full Information
NCT ID
NCT03449303
First Posted
January 8, 2018
Last Updated
October 30, 2020
Sponsor
Augusta University
Collaborators
American Holistic Nurses Association, American Nurses Foundation, Ananda Apothecary, The Jojoba Company
1. Study Identification
Unique Protocol Identification Number
NCT03449303
Brief Title
Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention
Acronym
CIPN-EOI
Official Title
Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
June 25, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augusta University
Collaborators
American Holistic Nurses Association, American Nurses Foundation, Ananda Apothecary, The Jojoba Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Peripheral Neuropathies
Keywords
breast cancer, CIPN, Pain, QOL, Essential Oils
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.
Masking
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.
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EOI
Arm Type
Active Comparator
Arm Description
10% dilution of Curcuma longa, Piper nigrum, Pelargonium asperum, Zingiber officinale, Mentha x piperita, and Rosmarinus officinalis ct. cineole in Simmondsia chinensis
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Simmondsia chinensis
Intervention Type
Other
Intervention Name(s)
EOI
Intervention Description
Topically-applied oil
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Topically-applied oil
Primary Outcome Measure Information:
Title
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)
Description
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.
Time Frame
baseline and weekly for 6 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale - Pain (VAS)
Description
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.
Time Frame
Baseline and daily for 6 weeks
Title
Quality of Life Adult Cancer survivor (QLACS)
Description
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.
Time Frame
Baseline, week four and week seven
Title
Quality of Life: Chemotherapy-Induced Peripheral Neuropathy-20 (QOL:CIPN20)
Description
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.
Time Frame
Baseline, week four and week seven
Other Pre-specified Outcome Measures:
Title
Sleep-related questions
Description
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.
Time Frame
Baseline, week four and week seven
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie K Zadinsky, PhD
Organizational Affiliation
Augusta University
Official's Role
Study Chair
Facility Information:
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention
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