Aromatherapy for Integrated Cancer Care
Aromatherapy for Integrated 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 one or two 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.
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). Subjects will
 participate in the study for two or three chemotherapy cycles. The first cycle 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 one or two cycles are intervention cycle(s) using the assigned
 randomized aromatherapy. The subjects will rate the severity of seven different symptoms from
 0 to 10 each day the aromatherapy inhaler during one or two chemotherapy cycles (i.e., 7
 consecutive days during each chemotherapy cycle) and report if they felt the aromatherapy was
 helping with symptoms compared to the previous 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 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) 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 < 8 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.