Aromatherapy for Integrated Cancer Care
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 3/15/2019 |
| Start Date: | April 11, 2018 |
| End Date: | December 1, 2019 |
| Contact: | Julie Ryan Wolf |
| Email: | julie_ryan@urmc.rochester.edu |
| Phone: | 585-276-3862 |
Aromatherapy: An Integrative Option for Symptom Management in Cancer Care
The purpose of this clinical trial is to determine the feasibility and effectiveness of
aromatherapy in relief of commonly reported symptoms in cancer patients undergoing
chemotherapy. Aromatherapy is a noninvasive, minimal risk intervention that could potentially
alleviate the severity of treatment-related symptoms. This study will evaluate the ability of
four aromatherapy scents (ginger, lavender, orange, jojoba) to reduce the severity of seven
chemotherapy-induced symptoms (nausea, vomiting, pain, anxiety/distress, fatigue, sleep
difficulties, and lack of appetite). Jojoba oil is a " carrier oil" and will act as a placebo
comparator in this study. Jojoba oil is present in small amount (1 drop) in the ginger,
lavender, and orange aromatherapy inhalers. As part of the study, the participants will be
asked to use an aromatherapy inhaler, which resembles a lipstick container, during three
chemotherapy cycles. The participants will use the aromatherapy inhaler for 7 consecutive
days. The investigators will ask the participants questions regarding demographics, clinical
information, current severity of symptoms, and current methods of symptom management. There
is a non-intervention baseline cycle during which subjects rate the severity of the seven
different symptoms from 0 to 10 for seven consecutive days during their first chemotherapy
study cycle. The next two study cycles are intervention cycles using the randomized
aromatherapy. The participants will rate the severity of seven different symptoms from 0 to
10 each day the aromatherapy inhaler during each of the three chemotherapy cycles (i.e., 7
consecutive days during each chemotherapy cycle). At the end of the study, the participants
will be asked about his/her satisfaction with the aromatherapy used during the study. All of
these measurements will provide a better understanding of the effectiveness of aromatherapy
for symptom management.
aromatherapy in relief of commonly reported symptoms in cancer patients undergoing
chemotherapy. Aromatherapy is a noninvasive, minimal risk intervention that could potentially
alleviate the severity of treatment-related symptoms. This study will evaluate the ability of
four aromatherapy scents (ginger, lavender, orange, jojoba) to reduce the severity of seven
chemotherapy-induced symptoms (nausea, vomiting, pain, anxiety/distress, fatigue, sleep
difficulties, and lack of appetite). Jojoba oil is a " carrier oil" and will act as a placebo
comparator in this study. Jojoba oil is present in small amount (1 drop) in the ginger,
lavender, and orange aromatherapy inhalers. As part of the study, the participants will be
asked to use an aromatherapy inhaler, which resembles a lipstick container, during three
chemotherapy cycles. The participants will use the aromatherapy inhaler for 7 consecutive
days. The investigators will ask the participants questions regarding demographics, clinical
information, current severity of symptoms, and current methods of symptom management. There
is a non-intervention baseline cycle during which subjects rate the severity of the seven
different symptoms from 0 to 10 for seven consecutive days during their first chemotherapy
study cycle. The next two study cycles are intervention cycles using the randomized
aromatherapy. The participants will rate the severity of seven different symptoms from 0 to
10 each day the aromatherapy inhaler during each of the three chemotherapy cycles (i.e., 7
consecutive days during each chemotherapy cycle). At the end of the study, the participants
will be asked about his/her satisfaction with the aromatherapy used during the study. All of
these measurements will provide a better understanding of the effectiveness of aromatherapy
for symptom management.
Inclusion Criteria:
- a) Male and female subjects, at least 12 years of age, prescribed chemotherapy for
cancer. (NOTE: Only non-pregnant females are eligible). University of Rochester will
enroll young adults (i.e., 21-39 years) and adults (i.e., 40 years and older). RPCI
will enroll adolescents (i.e., 12-20 years) and young adults (i.e., 21-39 years).
b) Scheduled to receive three or more cycles of chemotherapy. (NOTE: Subjects may have
already started chemotherapy, but must have at least three chemotherapy cycles
remaining in their current prescribed course.)
c) Day 1 of each chemotherapy cycle must be separated from Day 1 of the next
chemotherapy cycle by at least 10 days.
d) All cancer types and chemotherapy regimens are eligible. (NOTE: Monoclonal antibody
therapies are allowed if administered in combination with chemotherapy).
e) The chemotherapy regimen must be the same regimen for all study cycles. For
example, if a subject with breast cancer was prescribed TAC for Study Cycle 1, the
subject must receive TAC for Study Cycles 2 and 3.
f) Any number of chemotherapy administrations per week during a chemotherapy treatment
cycle is allowed.
g) Subjects must agree to discontinue their current use of aromatherapy for symptom
management during the course of the study. They must solely use the jojoba and
aromatherapy inhalers provided by the study during the course of the study.
h) Subjects must be able to read and understand English, as well as provide informed
consent in order to participate in this study.
Exclusion Criteria:
- a) Subjects < 12 years old are not eligible for participation in this study.
b) Pregnant females are ineligible for the study because pregnancy is a
contraindication for chemotherapy and exposure to essentials oils.
c) Subjects with more than six weeks between chemotherapy treatment cycles are not
eligible.
d) Concurrent radiation therapy or interferon treatment is not allowed.
e) Subjects with any known allergy to ginger, lavender, orange, citrus of any kind,
jojoba, or essential oils are not eligible.
We found this trial at
2
sites
Rochester, New York 14642
Phone: 585-276-3862
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