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| Name | Class |
|---|---|
| American Holistic Nurses Association | UNKNOWN |
| American Nurses Foundation | OTHER |
| Ananda Apothecary | UNKNOWN |
| The Jojoba Company |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Simmondsia chinensis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EOI | Other | Topically-applied oil |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and weekly for 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and daily for 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep-related questions | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julie K Zadinsky, PhD | Augusta University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Augusta University | Augusta | Georgia | 30912 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010523 | Peripheral Nervous System Diseases |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| UNKNOWN |
The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.
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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.
| Other |
Topically-applied oil |
|
| 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. | 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. | Baseline, week four and week seven |
| Baseline, week four and week seven |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |