Hematological MalignanciesAROM-HEMATONCT06150469
Efficacy of Inhaled Aromatherapy on Nausea and Vomiting in Hematological Malignancies
A study testing "Blend of ginger and lemon essential oils", "Neutral oil" in people with Hematological Malignancies, run by University Hospital, Limoges at 4 sites in France.
Trial summary
This project will optimise the management of chemotherapy-induced nausea and vomiting, with improvements in nausea and vomiting scores, quality of life and appetite expected in participants benefiting from the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematological Malignancies
- What is being tested?
- "Blend of ginger and lemon essential oils", "Neutral oil"
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 4 sitesFrance
- Study dates
- 17 Apr 2024to 16 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 years,
- Chemo-naive patients at inclusion,
- Patients with haematological malignancies treated treated with chemotherapy,
- Patients physically and mentally able to use the aromastick,
- Patients who speak, read and write French,
- Patients who have given signed consent,
- Patients with social security cover.
Who cannot join
- Asthmatic patients.
- Patients with anosmia.
- Patients allergic to EO, lemon or ginger.
- Patients who have already received aromatherapy to treat chemotherapy-induced nausea and vomiting,
- Patients practising herbal medicine or acupuncture,
- Pregnant and breast-feeding women,
Show all 9Show fewer
- Patients under guardianship, tutorship or curatorship,
- Patients taking part in interventional studies involving antiemetic drugs or nutritional products,
- Patients who have already had cancer.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
CH BRIVE
Brivé, 19100
Ludivine BESSE, 05 55 92 60 00, ludivine.besse@gmail.com
- Recruiting
Chu La Reunion
La Réunion, 97448
Yacine DJAFFER, 02 62 35 91 78, yacine.djaffer@chu-reunion.fr
- Recruiting
University Hospital, Limoges
Limoges, 87042
Jean TONIOLO, 0555055555, Jean.TONIOLO@chu-limoges.fr
- Recruiting
Ch Poissy
Saint-Germain-en-Laye, 78100
Christelle HILLION, 01 39 27 40 50, christelle.hillion@gmail.com
About this study
Official title: Efficacy of Ginger and Lemon Essential Oil Inhalation on Chemotherapy-induced Nausea and Vomiting in Patients with Haematological Malignancies: a Multicenter, Double-blind, Randomised Controlled Trial
This project will optimise the management of chemotherapy-induced nausea and vomiting, with improvements in nausea and vomiting scores, quality of life and appetite expected in participants benefiting from the intervention. In all cases, the use of complementary methods is recommended and improves the management of people with cancer because they offer a person-centred approach.
Read the detailed description
The aim is to evaluate the efficacy of inhalation of a mixture of ginger and lemon Essential Oils (EO) versus placebo in addition to conventional antiemetic treatments on the intensity of chemo-induced nausea during the acute phase D1 (H24) of its onset in patients with C1 haematological malignancies.
This multicentre study will be carried out in 5 establishments (haematology and oncology care sectors), which represents a very high potential for inclusion.
In addition, the investigator expect a very high acceptance rate for this study. In fact, in the context of CINV, this care strategy may meet a patient's expectation of symptoms (nausea, vomiting) that they find difficult to manage. Finally, it is known that patients in these care sectors are very keen on supportive care to improve their quality of life, so this is a potentially very interesting opportunity without any particular risk that is offered to participants in this study.
A nurse and a doctor with a postgraduate diploma in aromatherapy are coordinating the team, with the support of a nurse trained in evidence-based practice research methodology. Institutional procedures drawn up by the team at Limoges University Hospital describe the general procedure for using aromatherapy in a scientific and safe way, the protocols that can be used to describe the operating methods, the traceability of the manufacture of the mixtures and their administration, and the evaluation of their effectiveness. Supporting documents, an information note and a monitoring sheet have been created and are being used.
- Conditions
- Hematological Malignancies
- Being tested
- "Blend of ginger and lemon essential oils", "Neutral oil"
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Blend of ginger and lemon essential oils", "Neutral oil"Combination product
Patients will be given aromasticks to inhale the blend of essential oils.
| Study group | Role | What they receive |
|---|---|---|
| Blend of ginger and lemon essential oils | Active comparator | The experimental group will benefit from conventional management of NVCI (antiemetic prophylaxis in accordance with ESMO international recommendations) plus an aromastick of ginger and lemon essential oils renewed with each course of chemotherapy.
Patients were included for 3 cycles of chemotherapy (C1, C2, C3). Receives: Combination Product: "Blend of ginger and lemon essential oils", "Neutral oil" |
| Neutral oil | Placebo comparator | The control group will receive conventional management (antiemetic prophylaxis according to international recommendations, ESMO) of NVCI plus a placebo of aromastick containing a neutral, odourless oil, renewed with each course of chemotherapy. Receives: Combination Product: "Blend of ginger and lemon essential oils", "Neutral oil" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of inhaled aromatherapy on acute nausea
To assess difference of nausea intensity score measured by MAT Tool between groups oils (EO) of ginger and lemon versus placebo in addition to addition to conventional antiemetic treatments on intensity of chemo-induced nausea during the acute phase D1 (H24) of onset in patients with haematological malignancies C1 haematological malignancies.
MAT is used to self-assess the prevention and control of chemotherapy-induced nausea and vomiting. It comprises 2 evaluation parts: the first is a Likert scale assessing the intensity of chemotherapy-induced nausea (0-10), and the second is a record of the frequency of vomiting in the acute (H24) and delayed (H96) phases of chemo-induced nausea and vomiting onset.
Measured: 1 month, 2 months and 3 months
Secondary outcomes (10)
Efficacy of inhaled aromatherapy on vomiting frequency
To evaluate difference of vomiting fréquency measure by MAT Tool between groups.
MAT is used to self-assess the prevention and control of chemotherapy-induced nausea and vomiting. It comprises 2 evaluation parts: the first is a Likert scale assessing the intensity of chemotherapy-induced nausea (0-10), and the second is a record of the frequency of vomiting in the acute (H24) and delayed (H96) phases of chemo-induced nausea and vomiting onset.
Measured: 1 day, 1 month
Efficacy of inhaled aromatherapy on acute nausea between 4 days and 1 month
To assess difference of nausea intensity score measured by MAT Tool between groups.
MAT is used to self-assess the prevention and control of chemotherapy-induced nausea and vomiting. It comprises 2 evaluation parts: the first is a Likert scale assessing the intensity of chemotherapy-induced nausea (0-10), and the second is a record of the frequency of vomiting in the acute (H24) and delayed (H96) phases of chemo-induced nausea and vomiting onset.
Measured: 4 days, 1 month
Efficacy of inhaled aromatherapy on vomiting frequency between 4 days and 1 month
To evaluate difference of vomiting fréquency measure by MAT Tool between groups.
MAT is used to self-assess the prevention and control of chemotherapy-induced nausea and vomiting. It comprises 2 evaluation parts: the first is a Likert scale assessing the intensity of chemotherapy-induced nausea (0-10), and the second is a record of the frequency of vomiting in the acute (H24) and delayed (H96) phases of chemo-induced nausea and vomiting onset.
Measured: 4 days, 1 month
Efficacy of inhaled aromatherapy
To compare the efficacy of inhaled aromatherapy on the evolution of nausea intensity in the acute phase acute phase (D1) and then the delayed phase (D4) chemotherapy cycles (C1, C2 and C3).
MAT is used to self-assess the prevention and control of chemotherapy-induced nausea and vomiting. It comprises 2 evaluation parts: the first is a Likert scale assessing the intensity of chemotherapy-induced nausea (0-10), and the second is a record of the frequency of vomiting in the acute (H24) and delayed (H96) phases of chemo-induced nausea and vomiting onset.
Measured: 1 month, 2 months and 3 months
Anticipatory nausea
Compare the intensity of chemo-induced nausea. Compared the mean difference of anticipatory nausea intensity score measured by a Likert scale (ranging from 0-10 with zéro none and 10 as much as possible) between groups before the start of each cycle of chemotherapy (C1, C2, C3) between groups.
Measured: 1 month, 2 months and 3 months
Compare the proportion of chemically-induced emesis
Compare the proportion of chemically-induced emesis before the start of each cycle of chemotherapy (C1, C2, C3) between groups.
Measured: 1 month, 2 months and 3 months
Independent determinants of the presence of nausea then vomiting
To identify, in patients who received aromatherapy, the association between independent determinants of the presence of nausea then vomiting at the acute phase (D1) and at the delayed phase (D4) of the first cycle of chemotherapy (C1) (sex, age, anticipation of CINV, nausea terrain, history of nausea/vomiting, history of chemotherapy, motion sickness, tolerance of EO odour).
Measured: 1 month, 2 months and 3 months
Compare and describe the use of antiemetics use of antiemetics
Compare and describe the use of antiemetics use of antiemetics and write down the use of EO inhalations EO inhalations "if needed" during the acute (D1), delayed (D4) and anticipated phase of CINV (H0) during the 3 cycles of chemotherapy (C1, C2 and C3).
Measured: 1 month, 2 months and 3 months
Impact of inhaled aromatherapy on quality of life
Compare quality of life between the two groups at each each cycle of chemotherapy (C1,C2 and C3). Difference of quality of life score (EORTC QLQC30) between groups at each cycle.
EORTC QLQC 30 is European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire.
This self-questionnaire, validated in French, assesses quality of life specific to cancer. It is intended for all cancer patients, regardless of location.
EORTC QLQC 30 contains 30 items and assesses 15 dimensions of quality of life :
- 5 functional scales: physical, cognitive, social, emotional or psychological and limitations in daily activities;
- 1 global health/quality of life scale;
- 9 symptom scales: tiredness, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation and diarrhea, financial problems related with the disease.
Measured: 1 month, 2 months and 3 months
Efficacy of inhaled aromatherapy on dietary intake
To compare the effect of inhalation of ginger + lemon EO versus placebo in addition to conventional antiemetic treatments on diet during C1, C2, C3. Difference of dietary intake measured by SEFI scale between groups.
SEFI (Score d'Evaluation Facile des Ingesta - Ingesta Easy Evaluation Score) / LA description : SEFI is a visual assessment, by the patient himself or with the help of a caregiver, of his food intake, using an analog scale (0 to 10), or a choice of portions consumed.
Measured: 1 month, 2 months and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start17 Apr 2024
- Primary completion16 Dec 2025 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematological MalignanciesStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150469
- Sponsor's protocol ID
- 87RI23_0013-AROM-HEMATO
- Acronym
- AROM-HEMATO
- Status last verified
- Dec 2024
- First submitted
- 7 Sep 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ginger and Lemon Essential Oil Inhalation on Chemotherapy-induced Nausea and Vomiting in Patients with Haematological Malignancies: a Multicenter, Double-blind, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06150469
- Acronym / sponsor ID
- AROM-HEMATO / 87RI23_0013-AROM-HEMATO
- Conditions
- Hematological Malignancies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 17 Apr 2024 (actual)
- Primary completion
- 16 Dec 2025 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 29 Nov 2023 (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.
This project will optimise the management of chemotherapy-induced nausea and vomiting, with improvements in nausea and vomiting scores, quality of life and appetite expected in participants benefiting from the intervention. In all cases, the use of complementary methods is recommended and improves the management of people with cancer because they offer a person-centred approach.
Detailed description
The aim is to evaluate the efficacy of inhalation of a mixture of ginger and lemon Essential Oils (EO) versus placebo in addition to conventional antiemetic treatments on the intensity of chemo-induced nausea during the acute phase D1 (H24) of its onset in patients with C1 haematological malignancies.
This multicentre study will be carried out in 5 establishments (haematology and oncology care sectors), which represents a very high potential for inclusion.
In addition, the investigator expect a very high acceptance rate for this study. In fact, in the context of CINV, this care strategy may meet a patient's expectation of symptoms (nausea, vomiting) that they find difficult to manage. Finally, it is known that patients in these care sectors are very keen on supportive care to improve their quality of life, so this is a potentially very interesting opportunity without any particular risk that is offered to participants in this study.
A nurse and a doctor with a postgraduate diploma in aromatherapy are coordinating the team, with the support of a nurse trained in evidence-based practice research methodology. Institutional procedures drawn up by the team at Limoges University Hospital describe the general procedure for using aromatherapy in a scientific and safe way, the protocols that can be used to describe the operating methods, the traceability of the manufacture of the mixtures and their administration, and the evaluation of their effectiveness. Supporting documents, an information note and a monitoring sheet have been created and are being used.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Blend of ginger and lemon essential oils | Active comparator | Combination Product: "Blend of ginger and lemon essential oils", "Neutral oil"The experimental group will benefit from conventional management of NVCI (antiemetic prophylaxis in accordance with ESMO international recommendations) plus an aromastick of ginger and lemon essential oils renewed with each course of chemotherapy. Patients were included for 3 cycles of chemotherapy (C1, C2, C3). |
| Neutral oil | Placebo comparator | Combination Product: "Blend of ginger and lemon essential oils", "Neutral oil"The control group will receive conventional management (antiemetic prophylaxis according to international recommendations, ESMO) of NVCI plus a placebo of aromastick containing a neutral, odourless oil, renewed with each course of chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged over 18 years,
- Chemo-naive patients at inclusion,
- Patients with haematological malignancies treated treated with chemotherapy,
- Patients physically and mentally able to use the aromastick,
- Patients who speak, read and write French,
Key exclusion criteria (9 listed)
- Asthmatic patients.
- Patients with anosmia.
- Patients allergic to EO, lemon or ginger.
- Patients who have already received aromatherapy to treat chemotherapy-induced nausea and vomiting,
- Patients practising herbal medicine or acupuncture,
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 |
|---|---|---|
| "Blend of ginger and lemon essential oils", "Neutral oil"Patients will be given aromasticks to inhale the blend of essential oils. | Combination product | Blend of ginger and lemon essential oils, Neutral oil |
Primary outcome
Efficacy of inhaled aromatherapy on acute nausea
Time frame: 1 month, 2 months and 3 months
To assess difference of nausea intensity score measured by MAT Tool between groups oils (EO) of ginger and lemon versus placebo in addition to addition to conventional antiemetic treatments on intensity of chemo-induced nausea during the acute phase D1 (H24) of onset in patients with haematological malignancies C1 haematological malignancies. MAT is used to self-assess the prevention and control of chemotherapy-induced nausea and vomiting. It comprises 2 evaluation parts: the first is a Likert scale assessing the intensity of chemotherapy-induced nausea (0-10), and the second is a record of the frequency of vomiting in the acute (H24) and delayed (H96) phases of chemo-induced nausea and vomiting onset.
10 secondary outcomes
Efficacy of inhaled aromatherapy on vomiting frequency
Time frame: 1 day, 1 month
Efficacy of inhaled aromatherapy on acute nausea between 4 days and 1 month
Time frame: 4 days, 1 month
Efficacy of inhaled aromatherapy on vomiting frequency between 4 days and 1 month
Time frame: 4 days, 1 month
Efficacy of inhaled aromatherapy
Time frame: 1 month, 2 months and 3 months
Anticipatory nausea
Time frame: 1 month, 2 months and 3 months
Compare the proportion of chemically-induced emesis
Time frame: 1 month, 2 months and 3 months
Independent determinants of the presence of nausea then vomiting
Time frame: 1 month, 2 months and 3 months
Compare and describe the use of antiemetics use of antiemetics
Time frame: 1 month, 2 months and 3 months
Impact of inhaled aromatherapy on quality of life
Time frame: 1 month, 2 months and 3 months
Efficacy of inhaled aromatherapy on dietary intake
Time frame: 1 month, 2 months and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Blend of ginger and lemon essential oils", "Neutral oil" in people with Hematological Malignancies, run by University Hospital, Limoges at 4 sites in France.
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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of inhaled aromatherapy on acute nausea (time frame: 1 month, 2 months and 3 months). 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 12 Dec 2024.