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Aromatherapy for Chemotherapy-induced Symptoms

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ClinicalTrials.gov Identifier: NCT02670941
Recruitment Status : Terminated (Slow accrual; Received grant funding for a similar but different study.)
First Posted : February 2, 2016
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Julie Ryan, University of Rochester

Tracking Information
First Submitted Date  ICMJE January 15, 2016
First Posted Date  ICMJE February 2, 2016
Last Update Posted Date January 24, 2019
Study Start Date  ICMJE January 2016
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
Mean change in severity in symptoms [ Time Frame: up to 11 weeks ]
Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02670941 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
  • change in mean peak severity for nausea across all three cycles [ Time Frame: up to 11 weeks ]
    Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format.
  • change in mean peak severity for vomiting across all three cycles [ Time Frame: up to 11 weeks ]
    Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format.
  • change in mean peak severity for anxiety/distress across all three cycles [ Time Frame: up to 11 weeks ]
    Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format.
  • change in mean peak severity for pain across all three cycles [ Time Frame: up to 11 weeks ]
    Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format.
  • change in mean peak severity for fatigue across all three cycles [ Time Frame: up to 11 weeks ]
    Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format.
  • change in mean peak severity for sleep difficulties across all three cycles [ Time Frame: up to 11 weeks ]
    Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format.
  • change in mean peak severity for lack of appetite across all three cycles [ Time Frame: up to 11 weeks ]
    Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format.
  • the number of participants who found the aromatherapy acceptable [ Time Frame: up to 11 weeks ]
    The following questions will be asked of the subjects to obtain qualitative feedback to further evaluate acceptability of the aromatherapy inhalers: 1) What two things did you like about your aromatherapy inhaler?; 2) What two things did subjects dislike about the aromatherapy inhaler?; 3) Was the aromatherapy inhaler easy to use?; 4) Did subjects feel that the aromatherapy inhaler reduced symptoms from chemotherapy? Please circle the symptoms that seemed to be helped the most.; 5) Would the subject use this aromatherapy inhaler again in the future?; 6) Would the subject recommend this aromatherapy inhaler to others?; 7) What word or statement would the subject use to describe their experience during this clinical trial?; and 8) What intervention arm do subjects think they were in? All of these data will help determine if the aromatherapy inhalers and scents are acceptable and feasible to use for in cancer subjects during chemotherapy.
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 Chemotherapy-induced Symptoms
Official Title  ICMJE Aromatherapy for Management of Chemotherapy-induced Symptoms
Brief Summary The rationale behind the proposed study is to determine the initial effectiveness of aromatherapy in relief of commonly reported symptoms in cancer patients undergoing chemotherapy.
Detailed Description The proposed study is an exploratory trial to evaluate the use of aromatherapy for symptom management in patients undergoing chemotherapy. The investigators will accrue 120 adult cancer subjects undergoing chemotherapy in a initial efficacy study to determine the effectiveness of three different aromatherapies (ginger, lavender, or orange) on chemotherapy-related symptoms (nausea, vomiting, pain, anxiety, sleep difficulties, fatigue, and lack of appetite) compared to placebo (i.e., jojoba). All subjects will be randomized to one of the four arms for symptom management during three different chemotherapy cycles. The investigators will examine the incidence and severity of the seven symptoms at each chemotherapy cycle. The preliminary data from this study will elucidate the relationships between certain aromatherapies and specific symptom relief, which can be further evaluated in a larger confirmatory study of subjects undergoing chemotherapy or other types of cancer treatment. This study will provide clinical evidence regarding the incorporation of aromatherapy into cancer patient care.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy Symptoms
Intervention  ICMJE
  • Drug: Ginger
    The ginger oil (GIN-106) was steam distilled from fresh ginger grown in Madagascar. The ginger oil contains 64.23% sesquiterpenes, 18.5% monoterpenes, and 3.28% aldehydes. The aroma of ginger is described as spicy, sweet, and warm.
  • Drug: Lavender
    The lavender oil (LAV-110) was steam distilled from lavender grown in Kashmir Valley in India. The lavender oil contains 53.22% esters, 31.86% monoterpenols, and 4.88% oxides. The aroma of lavender is described as floral, fresh, herbaceous, and sweet.
  • Drug: Orange
    The orange oil (ORG-114) was cold-pressed and steam distilled from oranges in South Africa. The orange oil contains 97.21% monoterpenes, 0.73% aldehydes, and 0.7% monoterpenols. The aroma of orange is described as citrus, fresh, fruity, and sweet.
  • Drug: Jojoba
    The jojoba oil is certified organic and pesticide-free pure oil. Jojoba has a mild scent and can be used as a "fixative" for other essential oils.
Study Arms  ICMJE
  • Experimental: Ginger
    Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).
    Intervention: Drug: Ginger
  • Experimental: Lavender
    Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).
    Intervention: Drug: Lavender
  • Experimental: Orange
    Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).
    Intervention: Drug: Orange
  • Placebo Comparator: Jojoba
    Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).
    Intervention: Drug: Jojoba
Publications *

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 22, 2019)
31
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2016)
120
Actual Study Completion Date  ICMJE September 12, 2018
Actual Primary Completion Date September 12, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Non-pregnant adults between the ages of 21 to 89 years of age with diagnosis of cancer and be scheduled to receive at least three more cycles of chemotherapy.
  • Subjects must have had at least one chemotherapy cycle in their current prescribed course and have at least three additional chemotherapy cycles planned.
  • Day 1 of each chemotherapy cycle must be separated from Day 1 of the next chemotherapy cycles by at least 12 days.
  • All chemotherapy regimens are eligible.
  • Any number of chemotherapy administrations per week during a chemotherapy treatment cycle is allowed.
  • Subjects agree to discontinue any current aromatherapy usage and only use the study aromatherapy for symptom management during the course of the study. NOTE: Patients can continue to use scented soaps, lotions, shampoos, body sprays, perfume/cologne, candles, or air fresheners that they regularly use.
  • Subjects must be able to read and understand English, as well as provide informed consent in order to participate in this study.

Exclusion Criteria:

  • Subjects < 21 years old or > 89 years old are not eligible for participation in this study at the University of Rochester.
  • Pregnant females are ineligible for the study because pregnancy is a contraindication for chemotherapy and exposure to essentials oils.
  • Subjects who are chemotherapy-naïve are ineligible.
  • Subjects with more than four weeks between chemotherapy treatment cycles are not eligible.
  • Concurrent radiation therapy or interferon treatment is not allowed.
  • Subjects that have used or are currently using aromatherapy inhalation for symptom management are not eligible.
  • Subjects with any known allergy to ginger, lavender, orange, citrus of any kind, jojoba, or essential oils.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670941
Other Study ID Numbers  ICMJE RSRB57258
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Julie Ryan, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Julie Ryan, PhD, MPH University of Rochester
PRS Account University of Rochester
Verification Date January 2019

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