NCT02670941

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2016

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 2, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2018

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

2.7 years

First QC Date

January 15, 2016

Last Update Submit

January 22, 2019

Conditions

Chemotherapy Symptoms

Keywords

aromatherapychemotherapygingerlavenderorangejojobaessential oilscancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    up to 11 weeks

Secondary Outcomes (8)

  • change in mean peak severity for nausea across all three cycles

    up to 11 weeks

  • change in mean peak severity for vomiting across all three cycles

    up to 11 weeks

  • change in mean peak severity for anxiety/distress across all three cycles

    up to 11 weeks

  • change in mean peak severity for pain across all three cycles

    up to 11 weeks

  • change in mean peak severity for fatigue across all three cycles

    up to 11 weeks

  • +3 more secondary outcomes

Study Arms (4)

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).

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).

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).

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).

Drug: Jojoba

Interventions

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.

Ginger
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.

Lavender
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.

Orange
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.

Jojoba

Eligibility Criteria

Age21 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center, Wilmot Canter Center

Rochester, New York, 14642, United States

Location

Related Publications (26)

  • 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.

    PMID: 22784340BACKGROUND

  • Stringer 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.

    PMID: 21457903BACKGROUND

  • Bradley 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.

    PMID: 17289317BACKGROUND

  • de 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.

    PMID: 14751465BACKGROUND

  • Dyer 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.

    PMID: 25486854BACKGROUND

  • Boehm 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.

    PMID: 23983386BACKGROUND

  • Lillehei 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.

    PMID: 24720812BACKGROUND

  • Wood 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.

    PMID: 16676010BACKGROUND

  • Jordan 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.

    PMID: 24157984BACKGROUND

  • Marx 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.

    PMID: 23550785BACKGROUND

  • Ryan JL. Treatment of Chemotherapy-Induced Nausea in Cancer Patients. Eur Oncol. 2010;6(2):14-16. doi: 10.17925/eoh.2010.06.02.14.

    PMID: 21984886BACKGROUND

  • Ryan 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.

    PMID: 21818642BACKGROUND

  • Hines 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.

    PMID: 22513952BACKGROUND

  • Lien 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.

    PMID: 12576305BACKGROUND

  • Bone 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.

    PMID: 2205121BACKGROUND

  • Grontved A, Brask T, Kambskard J, Hentzer E. Ginger root against seasickness. A controlled trial on the open sea. Acta Otolaryngol. 1988 Jan-Feb;105(1-2):45-9. doi: 10.3109/00016488809119444.

    PMID: 3277342BACKGROUND

  • Kim S, Kim HJ, Yeo JS, Hong SJ, Lee JM, Jeon Y. The effect of lavender oil on stress, bispectral index values, and needle insertion pain in volunteers. J Altern Complement Med. 2011 Sep;17(9):823-6. doi: 10.1089/acm.2010.0644. Epub 2011 Aug 19.

    PMID: 21854199BACKGROUND

  • Goes TC, Antunes FD, Alves PB, Teixeira-Silva F. Effect of sweet orange aroma on experimental anxiety in humans. J Altern Complement Med. 2012 Aug;18(8):798-804. doi: 10.1089/acm.2011.0551. Epub 2012 Jul 31.

    PMID: 22849536BACKGROUND

  • Jafarzadeh M, Arman S, Pour FF. Effect of aromatherapy with orange essential oil on salivary cortisol and pulse rate in children during dental treatment: A randomized controlled clinical trial. Adv Biomed Res. 2013 Mar 6;2:10. doi: 10.4103/2277-9175.107968. Print 2013.

    PMID: 23930255BACKGROUND

  • Ndao DH, Ladas EJ, Cheng B, Sands SA, Snyder KT, Garvin JH Jr, Kelly KM. Inhalation aromatherapy in children and adolescents undergoing stem cell infusion: results of a placebo-controlled double-blind trial. Psychooncology. 2012 Mar;21(3):247-54. doi: 10.1002/pon.1898. Epub 2010 Dec 27.

    PMID: 22383266BACKGROUND

  • Habashy RR, Abdel-Naim AB, Khalifa AE, Al-Azizi MM. Anti-inflammatory effects of jojoba liquid wax in experimental models. Pharmacol Res. 2005 Feb;51(2):95-105. doi: 10.1016/j.phrs.2004.04.011.

    PMID: 15629254BACKGROUND

  • Kohara H, Miyauchi T, Suehiro Y, Ueoka H, Takeyama H, Morita T. Combined modality treatment of aromatherapy, footsoak, and reflexology relieves fatigue in patients with cancer. J Palliat Med. 2004 Dec;7(6):791-6. doi: 10.1089/jpm.2004.7.791.

    PMID: 15684846BACKGROUND

  • Pazyar N, Yaghoobi R, Ghassemi MR, Kazerouni A, Rafeie E, Jamshydian N. Jojoba in dermatology: a succinct review. G Ital Dermatol Venereol. 2013 Dec;148(6):687-91.

    PMID: 24442052BACKGROUND

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    PMID: 7481719BACKGROUND

  • Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6.

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    PMID: 8962456BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

ginger extractlavender oiljojoba wax

Study Officials

  • Julie Ryan, PhD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Dermatology

Study Record Dates

First Submitted

January 15, 2016

First Posted

February 2, 2016

Study Start

January 1, 2016

Primary Completion

September 12, 2018

Study Completion

September 12, 2018

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)