Chemotherapy SymptomsEarly Phase 1NCT02670941
Aromatherapy for Chemotherapy-induced Symptoms
A Early Phase 1 study testing Ginger, Lavender and Orange in people with Chemotherapy Symptoms, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Chemotherapy Symptoms
- What is being tested?
- Ginger, Lavender and Orange
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 12 Sep 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center, Wilmot Canter Center
Rochester, New York, 14642
About this study
Official title: Aromatherapy for Management of Chemotherapy-induced Symptoms
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.
Read the 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.
- Conditions
- Chemotherapy Symptoms
- Being tested
- Ginger, Lavender, Orange, Jojoba
- Keywords
- aromatherapy, chemotherapy, ginger, lavender, orange, jojoba, essential oils, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDrug
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.
LavenderDrug
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.
OrangeDrug
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.
JojobaDrug
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 group | Role | What they receive |
|---|---|---|
| Ginger | Experimental | 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). Receives: Drug: Ginger |
| Lavender | Experimental | 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). Receives: Drug: Lavender |
| Orange | Experimental | 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). Receives: Drug: Orange |
| Jojoba | Placebo comparator | 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). Receives: Drug: Jojoba |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in severity in symptoms
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.
Measured: up to 11 weeks
Secondary outcomes (8)
change in mean peak severity for nausea across all three cycles
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.
Measured: up to 11 weeks
change in mean peak severity for vomiting across all three cycles
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.
Measured: up to 11 weeks
change in mean peak severity for anxiety/distress across all three cycles
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.
Measured: up to 11 weeks
change in mean peak severity for pain across all three cycles
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.
Measured: up to 11 weeks
change in mean peak severity for fatigue across all three cycles
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.
Measured: up to 11 weeks
change in mean peak severity for sleep difficulties across all three cycles
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.
Measured: up to 11 weeks
change in mean peak severity for lack of appetite across all three cycles
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.
Measured: up to 11 weeks
the number of participants who found the aromatherapy acceptable
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.
Measured: up to 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion12 Sep 2018
- Study completion12 Sep 2018
Why it stopped: Slow accrual; Received grant funding for a similar but different study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Ryan, University of Rochester
- Investigators
- Julie Ryan, PhD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670941
- Sponsor's protocol ID
- RSRB57258
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2016
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lua PL, Zakaria NS. A brief review of current scientific evidence involving aromatherapy use for nausea and vomiting. J Altern Complement Med. 2012 Jun;18(6):534-40. doi: 10.1089/acm.2010.0862.
PubMed 22784340Stringer J, Donald G. Aromasticks in cancer care: an innovation not to be sniffed at. Complement Ther Clin Pract. 2011 May;17(2):116-21. doi: 10.1016/j.ctcp.2010.06.002.
PubMed 21457903Bradley BF, Starkey NJ, Brown SL, Lea RW. Anxiolytic effects of Lavandula angustifolia odour on the Mongolian gerbil elevated plus maze. J Ethnopharmacol. 2007 May 22;111(3):517-25. doi: 10.1016/j.jep.2006.12.021. Epub 2006 Dec 27.
PubMed 17289317de Almeida RN, Motta SC, de Brito Faturi C, Catallani B, Leite JR. Anxiolytic-like effects of rose oil inhalation on the elevated plus-maze test in rats. Pharmacol Biochem Behav. 2004 Feb;77(2):361-4. doi: 10.1016/j.pbb.2003.11.004.
PubMed 14751465Dyer J, Cleary L, Ragsdale-Lowe M, McNeill S, Osland C. The use of aromasticks at a cancer centre: a retrospective audit. Complement Ther Clin Pract. 2014 Nov;20(4):203-6. doi: 10.1016/j.ctcp.2013.11.006. Epub 2013 Nov 28.
PubMed 25486854Boehm K, Bussing A, Ostermann T. Aromatherapy as an adjuvant treatment in cancer care--a descriptive systematic review. Afr J Tradit Complement Altern Med. 2012 Jul 1;9(4):503-18. doi: 10.4314/ajtcam.v9i4.7. eCollection 2012.
PubMed 23983386Lillehei AS, Halcon LL. A systematic review of the effect of inhaled essential oils on sleep. J Altern Complement Med. 2014 Jun;20(6):441-51. doi: 10.1089/acm.2013.0311. Epub 2014 Apr 10.
PubMed 24720812Wood LJ, Nail LM, Gilster A, Winters KA, Elsea CR. Cancer chemotherapy-related symptoms: evidence to suggest a role for proinflammatory cytokines. Oncol Nurs Forum. 2006 May 3;33(3):535-42. doi: 10.1188/06.ONF.535-542.
PubMed 16676010Jordan K, Gralla R, Jahn F, Molassiotis A. International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV): content and implementation in daily routine practice. Eur J Pharmacol. 2014 Jan 5;722:197-202. doi: 10.1016/j.ejphar.2013.09.073. Epub 2013 Oct 21.
PubMed 24157984Marx WM, Teleni L, McCarthy AL, Vitetta L, McKavanagh D, Thomson D, Isenring E. Ginger (Zingiber officinale) and chemotherapy-induced nausea and vomiting: a systematic literature review. Nutr Rev. 2013 Apr;71(4):245-54. doi: 10.1111/nure.12016. Epub 2013 Mar 13.
PubMed 23550785Ryan JL. Treatment of Chemotherapy-Induced Nausea in Cancer Patients. Eur Oncol. 2010;6(2):14-16. doi: 10.17925/eoh.2010.06.02.14.
PubMed 21984886Ryan JL, Heckler CE, Roscoe JA, Dakhil SR, Kirshner J, Flynn PJ, Hickok JT, Morrow GR. Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: a URCC CCOP study of 576 patients. Support Care Cancer. 2012 Jul;20(7):1479-89. doi: 10.1007/s00520-011-1236-3. Epub 2011 Aug 5.
PubMed 21818642Hines S, Steels E, Chang A, Gibbons K. Aromatherapy for treatment of postoperative nausea and vomiting. Cochrane Database Syst Rev. 2012 Apr 18;(4):CD007598. doi: 10.1002/14651858.CD007598.pub2.
PubMed 22513952Lien HC, Sun WM, Chen YH, Kim H, Hasler W, Owyang C. Effects of ginger on motion sickness and gastric slow-wave dysrhythmias induced by circular vection. Am J Physiol Gastrointest Liver Physiol. 2003 Mar;284(3):G481-9. doi: 10.1152/ajpgi.00164.2002.
PubMed 12576305Bone ME, Wilkinson DJ, Young JR, McNeil J, Charlton S. Ginger root--a new antiemetic. The effect of ginger root on postoperative nausea and vomiting after major gynaecological surgery. Anaesthesia. 1990 Aug;45(8):669-71. doi: 10.1111/j.1365-2044.1990.tb14395.x.
PubMed 2205121
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy for Management of Chemotherapy-induced Symptoms
- ClinicalTrials.gov ID
- NCT02670941
- Acronym / sponsor ID
- RSRB57258
- Conditions
- Chemotherapy Symptoms
- Keywords
- aromatherapy, chemotherapy, ginger, lavender, orange, jojoba, essential oils, cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual; Received grant funding for a similar but different study.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 12 Sep 2018 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ginger | Experimental | Drug: GingerSubjects 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). |
| Lavender | Experimental | Drug: LavenderSubjects 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). |
| Orange | Experimental | Drug: OrangeSubjects 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). |
| Jojoba | Placebo comparator | Drug: JojobaSubjects 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). |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GingerThe 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 | Ginger |
| LavenderThe 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 | Lavender |
| OrangeThe 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 | Orange |
| JojobaThe 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. | Drug | Jojoba |
Primary outcome
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.
8 secondary outcomes
change in mean peak severity for nausea across all three cycles
Time frame: up to 11 weeks
change in mean peak severity for vomiting across all three cycles
Time frame: up to 11 weeks
change in mean peak severity for anxiety/distress across all three cycles
Time frame: up to 11 weeks
change in mean peak severity for pain across all three cycles
Time frame: up to 11 weeks
change in mean peak severity for fatigue across all three cycles
Time frame: up to 11 weeks
change in mean peak severity for sleep difficulties across all three cycles
Time frame: up to 11 weeks
change in mean peak severity for lack of appetite across all three cycles
Time frame: up to 11 weeks
the number of participants who found the aromatherapy acceptable
Time frame: up to 11 weeks
Results and safety
The study was stopped early (reason given: Slow accrual; Received grant funding for a similar but different study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Background: PubMed 22784340Lua PL, Zakaria NS. A brief review of current scientific evidence involving aromatherapy use for nausea and vomiting. J Altern Complement Med. 2012 Jun;18(6):534-40. doi: 10.1089/acm.2010.0862.
- Background: PubMed 21457903Stringer J, Donald G. Aromasticks in cancer care: an innovation not to be sniffed at. Complement Ther Clin Pract. 2011 May;17(2):116-21. doi: 10.1016/j.ctcp.2010.06.002.
- Background: PubMed 17289317Bradley BF, Starkey NJ, Brown SL, Lea RW. Anxiolytic effects of Lavandula angustifolia odour on the Mongolian gerbil elevated plus maze. J Ethnopharmacol. 2007 May 22;111(3):517-25. doi: 10.1016/j.jep.2006.12.021. Epub 2006 Dec 27.
- Background: PubMed 14751465de Almeida RN, Motta SC, de Brito Faturi C, Catallani B, Leite JR. Anxiolytic-like effects of rose oil inhalation on the elevated plus-maze test in rats. Pharmacol Biochem Behav. 2004 Feb;77(2):361-4. doi: 10.1016/j.pbb.2003.11.004.
- Background: PubMed 25486854Dyer J, Cleary L, Ragsdale-Lowe M, McNeill S, Osland C. The use of aromasticks at a cancer centre: a retrospective audit. Complement Ther Clin Pract. 2014 Nov;20(4):203-6. doi: 10.1016/j.ctcp.2013.11.006. Epub 2013 Nov 28.
- Background: PubMed 23983386Boehm K, Bussing A, Ostermann T. Aromatherapy as an adjuvant treatment in cancer care--a descriptive systematic review. Afr J Tradit Complement Altern Med. 2012 Jul 1;9(4):503-18. doi: 10.4314/ajtcam.v9i4.7. eCollection 2012.
- Background: PubMed 24720812Lillehei AS, Halcon LL. A systematic review of the effect of inhaled essential oils on sleep. J Altern Complement Med. 2014 Jun;20(6):441-51. doi: 10.1089/acm.2013.0311. Epub 2014 Apr 10.
- Background: PubMed 16676010Wood LJ, Nail LM, Gilster A, Winters KA, Elsea CR. Cancer chemotherapy-related symptoms: evidence to suggest a role for proinflammatory cytokines. Oncol Nurs Forum. 2006 May 3;33(3):535-42. doi: 10.1188/06.ONF.535-542.
- Background: PubMed 24157984Jordan K, Gralla R, Jahn F, Molassiotis A. International antiemetic guidelines on chemotherapy induced nausea and vomiting (CINV): content and implementation in daily routine practice. Eur J Pharmacol. 2014 Jan 5;722:197-202. doi: 10.1016/j.ejphar.2013.09.073. Epub 2013 Oct 21.
- Background: PubMed 23550785Marx WM, Teleni L, McCarthy AL, Vitetta L, McKavanagh D, Thomson D, Isenring E. Ginger (Zingiber officinale) and chemotherapy-induced nausea and vomiting: a systematic literature review. Nutr Rev. 2013 Apr;71(4):245-54. doi: 10.1111/nure.12016. Epub 2013 Mar 13.
- Background: PubMed 21984886Ryan JL. Treatment of Chemotherapy-Induced Nausea in Cancer Patients. Eur Oncol. 2010;6(2):14-16. doi: 10.17925/eoh.2010.06.02.14.
- Background: PubMed 21818642Ryan JL, Heckler CE, Roscoe JA, Dakhil SR, Kirshner J, Flynn PJ, Hickok JT, Morrow GR. Ginger (Zingiber officinale) reduces acute chemotherapy-induced nausea: a URCC CCOP study of 576 patients. Support Care Cancer. 2012 Jul;20(7):1479-89. doi: 10.1007/s00520-011-1236-3. Epub 2011 Aug 5.
- Aromatherapy NAoH. Explore Aromatherapy: Safety Raleigh, NC2015Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Ryan, PhD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ginger, Lavender and Orange in people with Chemotherapy Symptoms, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual; Received grant funding for a similar but different study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in severity in symptoms (time frame: up to 11 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02670941, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.