CancerNCT03449511
Aromatherapy for Integrated Cancer Care
A study testing Ginger aromatherapy, Orange aromatherapy and Lavender aromatherapy in people with Cancer, run by University of Rochester at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Ginger aromatherapy, Orange aromatherapy and Lavender aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Apr 2018to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
- 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.)
- Day 1 of each chemotherapy cycle must be separated from Day 1 of the next chemotherapy cycle by at least 10 days.
- All cancer types and chemotherapy regimens are eligible. (NOTE: Monoclonal antibody therapies are allowed if administered in combination with chemotherapy).
- 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.
- Any number of chemotherapy administrations per week during a chemotherapy treatment cycle is allowed.
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
University of Rochester Medical Center, Wilmot Canter Center
Rochester, New York, 14642
About this study
Official title: Aromatherapy: An Integrative Option for Symptom Management in Cancer Care
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.
Read the 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
- Cancer
- Being tested
- Ginger aromatherapy, Orange aromatherapy, Lavender aromatherapy, Jojoba aromatherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginger aromatherapyOther
Three sniffs of aromatherapy inhaler four times daily for seven days.
Orange aromatherapyOther
Three sniffs of aromatherapy inhaler four times daily for seven days.
Lavender aromatherapyOther
Three sniffs of aromatherapy inhaler four times daily for seven days.
Jojoba aromatherapyOther
Three sniffs of aromatherapy inhaler four times daily for seven days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Jojoba aromatherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that complete the intervention.
Retention rate will be determined by arm.
Measured: 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).
Measured: 3 months
Secondary outcomes (2)
Mean composite severity score
A composite symptom severity score will be calculated for each day during each Study Cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1.
Measured: 3 months
Maximum composite severity score
The maximum composite symptom severity score will be the highest severity score across the 6 days for that cycle. The mean composite symptom severity score will be the mean of all six composite severity scores for each cycle. We will use ANCOVA analyses to compare the maximum composite symptom severity scores and mean composite symptom severity scores between Study Cycle 3 vs Study Cycle 1 and Study Cycle 2 vs. Study Cycle 1.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start11 Apr 2018
- Primary completion30 Dec 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Ryan Wolf, University of Rochester
- Investigators
- Julie Ryan Wolf, PhD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03449511
- Sponsor's protocol ID
- 71162
- Status last verified
- Aug 2023
- First submitted
- 22 Feb 2018
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not currently have a plant to share individual participant data with other researchers. However, de-identified data will be shared upon request. The data shared will not contain any personal identifiers and will not be able to be linked to study subjects. Study protocol and analysis plans can be shared with other investigators upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aromatherapy: An Integrative Option for Symptom Management in Cancer Care
- ClinicalTrials.gov ID
- NCT03449511
- Acronym / sponsor ID
- 71162
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ginger aromatherapy | Active comparator | Other: Ginger aromatherapyGinger 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. |
| Orange aromatherpy | Active comparator | Other: Orange aromatherapyOrange 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. |
| Lavender aromatherapy | Active comparator | Other: Lavender aromatherapyLavender 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. |
| Jojoba aromatherapy | Placebo comparator | Other: Jojoba aromatherapyJojoba 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. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days. | Other | Ginger aromatherapy |
| Orange aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days. | Other | Orange aromatherpy |
| Lavender aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days. | Other | Lavender aromatherapy |
| Jojoba aromatherapyThree sniffs of aromatherapy inhaler four times daily for seven days. | Other | Jojoba aromatherapy |
Primary outcome
Number of participants that complete the intervention.
Time frame: 3 months
Retention rate will be determined by arm.
Compliance rate
Time frame: 3 months
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).
2 secondary outcomes
Mean composite severity score
Time frame: 3 months
Maximum composite severity score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No. We do not currently have a plant to share individual participant data with other researchers. However, de-identified data will be shared upon request. The data shared will not contain any personal identifiers and will not be able to be linked to study subjects. Study protocol and analysis plans can be shared with other investigators upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Ryan Wolf, PhD, MPH principal investigator
University of Rochester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ginger aromatherapy, Orange aromatherapy and Lavender aromatherapy in people with Cancer, run by University of Rochester at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that complete the intervention. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.