Breast Cancer, Peripheral Neuropathies
Conditions
Keywords
breast cancer, CIPN, Pain, QOL, Essential Oils
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.
Interventions
OTHEREOI
Topically-applied oil
OTHERPlacebo
Topically-applied oil
Sponsors
American Holistic Nurses Association
American Nurses Foundation
Ananda Apothecary
The Jojoba Company
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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.
Intervention model description
The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale - Pain (VAS) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Sleep-related questions | 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. |
Countries
United States
Outcome results
None listed