Status:
COMPLETED
Aromatherapy for Integrated Cancer Care
Lead Sponsor:
University of Rochester
Conditions:
Cancer
Eligibility:
All Genders
8+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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/distr...
Eligibility Criteria
Inclusion
- a) Male and female subjects, at least 8 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., 8-20 years) and young adults (i.e., 21-39 years).
- b) Scheduled to receive two 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) University of Rochester will enroll subjects who are able to read and understand English or Spanish. RPCI will enroll subjects who are able to read and understand English. All subjects must be able to provide informed consent in order to participate in this study.
Exclusion
- Subjects \< 8 years old are not eligible for participation in this study.
- Pregnant females are ineligible for the study because pregnancy is a contraindication for chemotherapy and exposure to essentials oils.
- Subjects with more than six weeks between chemotherapy treatment cycles are not eligible.
- Concurrent radiation therapy or interferon treatment is not allowed.
- Subjects with any known allergy to ginger, lavender, orange, citrus of any kind, jojoba, or essential oils are not eligible.
Key Trial Info
Start Date :
April 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03449511
Start Date
April 11 2018
End Date
January 30 2023
Last Update
August 14 2023
Active Locations (2)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
University of Rochester Medical Center, Wilmot Canter Center
Rochester, New York, United States, 14642