Aromatherapy for Integrated Cancer Care

NCT03449511 | Completed

• 1 other identifier: 71162
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (2)

• Number of participants that complete the intervention.

  Retention rate will be determined by arm.

  3 months

• Compliance rate

  The compliance rate is the percentage of participants that report using the aromatherapy as described in protocol (i.e., at least three sniffs four times daily).

  3 months

Secondary Outcomes (2)

• Mean composite severity score

  3 months

• Maximum composite severity score

  3 months

Study Arms (4)

Ginger aromatherapy

ACTIVE COMPARATOR

Ginger essential oil (GIN-106) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.

Other: Ginger aromatherapy

Orange aromatherpy

ACTIVE COMPARATOR

Orange essential oil (ORG-114) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.

Other: Orange aromatherapy

Lavender aromatherapy

ACTIVE COMPARATOR

Lavender essential oil (LAV-110) in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles.

Other: Lavender aromatherapy

Jojoba aromatherapy

PLACEBO COMPARATOR

Jojoba oil in an aromatherapy inhaler. Subject will take 3 sniffs of the inhaler four times daily (morning, noon, evening, bedtime) for 7 consecutive days during two chemotherapy cycles. One drop of jojoba oil is on the other three aromatherapy inhalers. Jojoba oil is a "carreir oil" for essential oils which will be used as a comparator and placebo in this study.

Other: Jojoba aromatherapy

Interventions

Ginger aromatherapy OTHER

Three sniffs of aromatherapy inhaler four times daily for seven days.

Ginger aromatherapy

Orange aromatherapy OTHER

Three sniffs of aromatherapy inhaler four times daily for seven days.

Orange aromatherpy

Lavender aromatherapy OTHER

Three sniffs of aromatherapy inhaler four times daily for seven days.

Lavender aromatherapy

Jojoba aromatherapy OTHER

Three sniffs of aromatherapy inhaler four times daily for seven days.

Jojoba aromatherapy

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• a) Male and female subjects, at least 8 years of age, prescribed chemotherapy for cancer. (NOTE: Only non-pregnant females are eligible). University of Rochester will enroll young adults (i.e., 21-39 years) and adults (i.e., 40 years and older). RPCI will enroll adolescents (i.e., 8-20 years) and young adults (i.e., 21-39 years).
• b) Scheduled to receive two or more cycles of chemotherapy. (NOTE: Subjects may have already started chemotherapy, but must have at least three chemotherapy cycles remaining in their current prescribed course.)
• c) Day 1 of each chemotherapy cycle must be separated from Day 1 of the next chemotherapy cycle by at least 10 days.
• d) All cancer types and chemotherapy regimens are eligible. (NOTE: Monoclonal antibody therapies are allowed if administered in combination with chemotherapy).
• e) The chemotherapy regimen must be the same regimen for all study cycles. For example, if a subject with breast cancer was prescribed TAC for Study Cycle 1, the subject must receive TAC for Study Cycles 2 and 3.
• f) Any number of chemotherapy administrations per week during a chemotherapy treatment cycle is allowed.
• g) Subjects must agree to discontinue their current use of aromatherapy for symptom management during the course of the study. They must solely use the jojoba and aromatherapy inhalers provided by the study during the course of the study.
• h) University of Rochester will enroll subjects who are able to read and understand English or Spanish. RPCI will enroll subjects who are able to read and understand English. All subjects must be able to provide informed consent in order to participate in this study.

You may not qualify if:

• Subjects \< 8 years old are not eligible for participation in this study.
• Pregnant females are ineligible for the study because pregnancy is a contraindication for chemotherapy and exposure to essentials oils.
• Subjects with more than six weeks between chemotherapy treatment cycles are not eligible.
• Concurrent radiation therapy or interferon treatment is not allowed.
• Subjects with any known allergy to ginger, lavender, orange, citrus of any kind, jojoba, or essential oils are not eligible.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

University of Rochester Medical Center, Wilmot Canter Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Julie Ryan Wolf, PhD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: February 28, 2018
• Study Start: April 11, 2018
• Primary Completion: December 30, 2022
• Study Completion: January 30, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)