Clinical Trials Directory

Trials / Completed

CompletedNCT03449511

Aromatherapy for Integrated Cancer Care

Aromatherapy: An Integrative Option for Symptom Management in Cancer Care

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
83 (actual)
Sponsor
University of Rochester · Academic / Other
Sex
All
Age
8 Years
Healthy volunteers
Not accepted

Summary

The purpose of this clinical trial is to determine the feasibility and effectiveness of aromatherapy in relief of commonly reported symptoms in cancer patients undergoing chemotherapy. Aromatherapy is a noninvasive, minimal risk intervention that could potentially alleviate the severity of treatment-related symptoms. This study will evaluate the ability of four aromatherapy scents (ginger, lavender, orange, jojoba) to reduce the severity of seven chemotherapy-induced symptoms (nausea, vomiting, pain, anxiety/distress, fatigue, sleep difficulties, and lack of appetite). Jojoba oil is a " carrier oil" and will act as a placebo comparator in this study. Jojoba oil is present in small amount (1 drop) in the ginger, lavender, and orange aromatherapy inhalers. As part of the study, the participants will be asked to use an aromatherapy inhaler, which resembles a lipstick container, during three chemotherapy cycles. The participants will use the aromatherapy inhaler for 7 consecutive days. The investigators will ask the participants questions regarding demographics, clinical information, current severity of symptoms, and current methods of symptom management. There is a non-intervention baseline cycle during which subjects rate the severity of the seven different symptoms from 0 to 10 for seven consecutive days during their first chemotherapy study cycle. The next two study cycles are intervention cycles using the randomized aromatherapy. The participants will rate the severity of seven different symptoms from 0 to 10 each day the aromatherapy inhaler during one or two chemotherapy cycles (i.e., 7 consecutive days during each chemotherapy cycle). At the end of the study, the participants will be asked about his/her satisfaction with the aromatherapy used during the study. All of these measurements will provide a better understanding of the effectiveness of aromatherapy for symptom management.

Detailed description

This study will evaluate the ability of four aromatherapy scents (ginger, lavender, orange, jojoba) to reduce the severity of seven chemotherapy-induced symptoms (nausea, vomiting, pain, anxiety/distress, fatigue, sleep difficulties, and lack of appetite). Subjects will participate in the study for two or three chemotherapy cycles. The first cycle is a non-intervention baseline cycle during which subjects rate the severity of the seven different symptoms from 0 to 10 for seven consecutive days during their first chemotherapy study cycle. The next one or two cycles are intervention cycle(s) using the assigned randomized aromatherapy. The subjects will rate the severity of seven different symptoms from 0 to 10 each day the aromatherapy inhaler during one or two chemotherapy cycles (i.e., 7 consecutive days during each chemotherapy cycle) and report if they felt the aromatherapy was helping with symptoms compared to the previous cycle. At the end of the study, the participants will be asked about his/her satisfaction with the aromatherapy used during the study. All of these measurements will provide a better understanding of the effectiveness of aromatherapy for symptom management.

Conditions

Interventions

TypeNameDescription
OTHERGinger aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days.
OTHEROrange aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days.
OTHERLavender aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days.
OTHERJojoba aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days.

Timeline

Start date
2018-04-11
Primary completion
2022-12-30
Completion
2023-01-30
First posted
2018-02-28
Last updated
2023-08-14

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT03449511. Inclusion in this directory is not an endorsement.