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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

Tracking Information
First Submitted Date  ICMJE February 22, 2018
First Posted Date  ICMJE February 28, 2018
Last Update Posted Date March 13, 2019
Actual Study Start Date  ICMJE April 11, 2018
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • Number of participants that complete the intervention. [ Time Frame: 3 months ]
    Retention rate will be determined by arm.
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03449511 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aromatherapy for Integrated Cancer Care
Official Title  ICMJE Aromatherapy: An Integrative Option for Symptom Management in Cancer Care
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE
  • Other: Ginger aromatherapy
    Three sniffs of aromatherapy inhaler four times daily for seven days.
  • Other: Orange aromatherapy
    Three sniffs of aromatherapy inhaler four times daily for seven days.
  • Other: Lavender aromatherapy
    Three sniffs of aromatherapy inhaler four times daily for seven days.
  • Other: Jojoba aromatherapy
    Three sniffs of aromatherapy inhaler four times daily for seven days.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Ginger aromatherapy
  • 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.
    Intervention: Other: Orange aromatherapy
  • 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.
    Intervention: Other: Lavender aromatherapy
  • 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.
    Intervention: Other: Jojoba aromatherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 22, 2018)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Julie Ryan Wolf 585-276-3862 julie_ryan@urmc.rochester.edu
Contact: Madeline Forster 585-690-5533
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03449511
Other Study ID Numbers  ICMJE 71162
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Julie Ryan, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Rochester
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP