Clinical trial NCT02670941: Aromatherapy for Chemotherapy-induced Symptoms
Official title: Aromatherapy for Management of Chemotherapy-induced Symptoms
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Chemotherapy Symptoms
Keywords: aromatherapy
chemotherapy
ginger
lavender
orange
jojoba
essential oils
cancer
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2016-02-02
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in severity in symptoms
timeFrame: up to 11 weeks
Secondary outcomes:
measure: change in mean peak severity for nausea across all three cycles
timeFrame: up to 11 weeks
measure: change in mean peak severity for vomiting across all three cycles
timeFrame: up to 11 weeks
measure: change in mean peak severity for anxiety/distress across all three cycles
timeFrame: up to 11 weeks
measure: change in mean peak severity for pain across all three cycles
timeFrame: up to 11 weeks
measure: change in mean peak severity for fatigue across all three cycles
timeFrame: up to 11 weeks
measure: change in mean peak severity for sleep difficulties across all three cycles
timeFrame: up to 11 weeks
measure: change in mean peak severity for lack of appetite across all three cycles
timeFrame: up to 11 weeks
measure: the number of participants who found the aromatherapy acceptable
timeFrame: up to 11 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center, Wilmot Canter Center
state: New York
Study officials:
affiliation: University of Rochester
name: Julie Ryan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Axel R. The molecular logic of smell. Sci Am. 1995 Oct;273(4):154-9. doi: 10.1038/scientificamerican1095-154.
citation: 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.
citation: Little R, Yau L. Intent-to-treat analysis for longitudinal studies with drop-outs. Biometrics. 1996 Dec;52(4):1324-33.