Breast CancerCIPN-EOINCT03449303
Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention
A study testing EOI in people with Breast Cancer and Peripheral Neuropathies, run by Augusta University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Peripheral Neuropathies
- What is being tested?
- EOI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2018to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- non-English-speaking
- blindness
- pregnancy
- breastfeeding
- allergy to EOI or Peru balsam (cross-allergen)
- illegal substance usage
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study
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.
Read the 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.
- Conditions
- Breast Cancer, Peripheral Neuropathies
- Being tested
- EOI, Placebo
- Keywords
- breast cancer, CIPN, Pain, QOL, Essential Oils
- Medical subject headings
- Breast Neoplasms, Peripheral Nervous System Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOIOther
Topically-applied oil
PlaceboOther
Topically-applied oil
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: EOI |
| Placebo | Placebo comparator | Simmondsia chinensis Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and weekly for 6 weeks
Secondary outcomes (3)
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.
Measured: Baseline and daily for 6 weeks
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.
Measured: Baseline, week four and week seven
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.
Measured: Baseline, week four and week seven
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start25 Jun 2018
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- American Holistic Nurses Association, American Nurses Foundation, Ananda Apothecary, The Jojoba Company
- Responsible party
- Sponsor
- Investigators
- Julie K Zadinsky, PhD, Study chair, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449303
- Sponsor's protocol ID
- 1028595
- Acronym
- CIPN-EOI
- Status last verified
- Oct 2020
- First submitted
- 8 Jan 2018
- Last updated
- 2 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study
- ClinicalTrials.gov ID
- NCT03449303
- Acronym / sponsor ID
- CIPN-EOI / 1028595
- Conditions
- Breast Cancer, Peripheral Neuropathies
- Keywords
- breast cancer, CIPN, Pain, QOL, Essential Oils
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- American Holistic Nurses Association, American Nurses Foundation, Ananda Apothecary, The Jojoba Company
- Study start
- 25 Jun 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.
| Arm | Type | Receives |
|---|---|---|
| EOI | Active comparator | Other: EOI10% dilution of Curcuma longa, Piper nigrum, Pelargonium asperum, Zingiber officinale, Mentha x piperita, and Rosmarinus officinalis ct. cineole in Simmondsia chinensis |
| Placebo | Placebo comparator | Other: PlaceboSimmondsia chinensis |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- non-English-speaking
- blindness
- pregnancy
- breastfeeding
- allergy to EOI or Peru balsam (cross-allergen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOITopically-applied oil | Other | EOI |
| PlaceboTopically-applied oil | Other | Placebo |
Primary outcome
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.
3 secondary outcomes
Visual Analogue Scale - Pain (VAS)
Time frame: Baseline and daily for 6 weeks
Quality of Life Adult Cancer survivor (QLACS)
Time frame: Baseline, week four and week seven
Quality of Life: Chemotherapy-Induced Peripheral Neuropathy-20 (QOL:CIPN20)
Time frame: Baseline, week four and week seven
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie K Zadinsky, PhD study chair
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOI in people with Breast Cancer and Peripheral Neuropathies, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) (time frame: baseline and weekly for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.