NCT02670941

Aromatherapy for Chemotherapy-induced Symptoms

Aromatherapy for Management of Chemotherapy-induced Symptoms

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 21 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy Symptoms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-09-12
• Completion: 2018-09-12
• First posted: 2016-02-02
• Last updated: 2019-01-24

Locations

1 site across 1 country: United States