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Aromatherapy for Integrated Cancer Care

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ClinicalTrials.gov Identifier: NCT03449511
Recruitment Status : Recruiting
First Posted : February 28, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Ryan, University of Rochester

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 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.

Condition or disease Intervention/treatment Phase
Cancer Other: Ginger aromatherapy Other: Orange aromatherapy Other: Lavender aromatherapy Other: Jojoba aromatherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Aromatherapy: An Integrative Option for Symptom Management in Cancer Care
Actual Study Start Date : April 11, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Active Comparator: Ginger aromatherapy
Ginger essential oil (GIN-106) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.
Other: Ginger aromatherapy
Three sniffs of aromatherapy inhaler four times daily for seven days.

Active Comparator: Orange aromatherpy
Orange essential oil (ORG-114) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.
Other: Orange aromatherapy
Three sniffs of aromatherapy inhaler four times daily for seven days.

Active Comparator: Lavender aromatherapy
Lavender essential oil (LAV-110) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.
Other: Lavender aromatherapy
Three sniffs of aromatherapy inhaler four times daily for seven days.

Placebo Comparator: Jojoba aromatherapy
Jojoba oil in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. One drop of jojoba oil is on the other three aromatherapy inhalers. Jojoba oil is a "carreir oil" for essential oils which will be used as a comparator and placebo in this study.
Other: Jojoba aromatherapy
Three sniffs of aromatherapy inhaler four times daily for seven days.




Primary Outcome Measures :
  1. Number of participants that complete the intervention. [ Time Frame: 3 months ]
    Retention rate will be determined by arm.

  2. Compliance rate [ Time Frame: 3 months ]
    The compliance rate is the percentage of participants that report using the aromatherapy as described in protocol (i.e., at least three sniffs four times daily).


Secondary Outcome Measures :
  1. Mean composite severity score [ Time Frame: 3 months ]
    A composite symptom severity score will be calculated for each day during each Study Cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1.

  2. Maximum composite severity score [ Time Frame: 3 months ]
    The maximum composite symptom severity score will be the highest severity score across the 6 days for that cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03449511


Contacts
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Contact: Julie Ryan Wolf 585-276-3862 julie_ryan@urmc.rochester.edu
Contact: Madeline Forster 585-690-5533

Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Douglas McDaniel       Douglas.McDaniel@RoswellPark.org   
Sub-Investigator: Denise Rokitka, MD         
University of Rochester Medical Center, Wilmot Canter Center Recruiting
Rochester, New York, United States, 14642
Contact: Julie Ryan, PhD, MPH    585-276-3862    julie_ryan@urmc.rochester.edu   
Contact: Madeline Forster, MS    585-690-5533      
Sponsors and Collaborators
University of Rochester

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Responsible Party: Julie Ryan, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03449511     History of Changes
Other Study ID Numbers: 71162
First Posted: February 28, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No