Chemotherapy-Induced Nausea and Vomiting (CINV)NCT07292831
Geranium Inhalation Aromatherapy for Reducing Nausea and Vomiting in Cancer Patients Undergoing Chemotherapy
A study testing Geranium Inhalation Aromatherapy in people with Chemotherapy-Induced Nausea and Vomiting (CINV) and Cancer, run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.
Trial summary
Chemotherapy-induced nausea and vomiting (CINV) remain among the most distressing side effects experienced by cancer patients and can significantly affect treatment tolerance and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chemotherapy-Induced Nausea and Vomiting (CINV), Cancer
- What is being tested?
- Geranium Inhalation Aromatherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 1 Dec 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cancer.
- Currently undergoing intravenous chemotherapy regimen 1.
- Aged under 65 years.
- Body Mass Index (BMI) between 18.5 and 22.9 kg/m².
- Able and willing to provide informed consent.
- Able to communicate and follow study instructions.
Who cannot join
- Known allergy or sensitivity to essential oils or fragrances
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Geranium Inhalation Aromatherapy: An Alternative Therapy to Alleviate Nausea & Vomiting in Cancer Patients Undergoing Chemotherapy
Chemotherapy-induced nausea and vomiting (CINV) remain among the most distressing side effects experienced by cancer patients and can significantly affect treatment tolerance and quality of life. Geranium essential oil has been proposed as a complementary, non-pharmacological therapy that may help reduce nausea and vomiting through its calming and antiemetic properties.
This randomized controlled trial aims to evaluate the potential effectiveness of geranium inhalation aromatherapy in reducing nausea and vomiting among cancer patients undergoing chemotherapy. Ninety participants undergoing intravenous chemotherapy will be enrolled and randomly assigned to either the geranium aromatherapy group or the control group. The intervention group will receive inhalation of geranium essential oil, while the control group will receive no aromatherapy.Nausea and vomiting will be measured using the validated Index of Nausea, Vomiting, and Retching (INVR) before chemotherapy and 12 hours afterward. This study is designed to explore whether geranium inhalation aromatherapy may serve as a supportive complementary therapy to enhance comfort and overall quality of life for patients undergoing chemotherapy.
Read the detailed description
Chemotherapy is a primary treatment modality for many types of cancer but is frequently accompanied by adverse effects, particularly nausea and vomiting. These symptoms are triggered by complex interactions between neurotransmitters and receptors in both the gastrointestinal and central nervous systems. Although antiemetic medications have improved over the years, many patients continue to experience discomfort that negatively affects their quality of life. Complementary therapies such as aromatherapy are increasingly explored as supportive approaches to help alleviate these symptoms. Geranium essential oil (Pelargonium graveolens) possesses calming, anti-inflammatory, and potential antiemetic properties. Inhalation aromatherapy is thought to reduce nausea by stimulating olfactory pathways associated with relaxation and autonomic regulation. This study aims to investigate the potential benefit of geranium inhalation aromatherapy as an adjunct to standard chemotherapy care. This randomized controlled trial (RCT) involves 90 cancer patients undergoing intravenous chemotherapy at a public hospital in Surakarta, Indonesia. Participants are selected through simple random sampling. Inclusion criteria include patients aged under 65 years, with a BMI of 18.5-22.9 kg/m², receiving chemotherapy regimen 1, and willing to provide informed consent. Participants will be randomized into two groups: a treatment group receiving geranium inhalation aromatherapy and a control group receiving no aromatherapy. Baseline demographic and clinical characteristics-including age, gender, education level, occupation, body mass index, duration of illness, cancer stage, hemoglobin levels, leukocyte and platelet counts, kidney function, liver function, and chemotherapy status-will be recorded to ensure comparability between groups. Geranium aromatherapy will be administered through inhalation, a method known to deliver rapid olfactory stimulation and promote relaxation. Nausea and vomiting will be assessed using the Index of Nausea, Vomiting, and Retching (INVR), a reliable and widely used instrument for evaluating chemotherapy-related gastrointestinal symptoms. Measurements will be collected at baseline and 12 hours after chemotherapy. This study is expected to provide additional insight into the feasibility, safety, and potential role of aromatherapy-specifically geranium essential oil-in supporting the management of chemotherapy-induced nausea and vomiting as part of a holistic approach to cancer care.
- Being tested
- Geranium Inhalation Aromatherapy
- Keywords
- Cancer, Chemotherapy, Geranium Aromatherapy, Nausea, Vomiting
- Medical subject headings
- Vomiting, Neoplasms, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geranium Inhalation AromatherapyOther
Also called Geranium Essential Oil, Aromatherapy with Geranium Oil
Participants received inhalation aromatherapy using geranium essential oil (Pelargonium graveolens). The essential oil was administered through controlled inhalation during the chemotherapy session. Patients inhaled the aroma directly, allowing olfactory stimulation intended to reduce nausea and vomiting. The intervention was applied according to a standardized protocol, and nausea/vomiting were assessed before and 12 hours after chemotherapy using the Index of Nausea, Vomiting, and Retching (INVR).
| Study group | Role | What they receive |
|---|---|---|
| Geranium Aromatherapy | Experimental | Participants in this arm received geranium essential oil inhalation aromatherapy during chemotherapy. The aromatherapy was administered by allowing patients to inhale geranium essential oil through a controlled inhalation method. This intervention was provided during the chemotherapy session, and nausea/vomiting levels were assessed before and 12 hours after chemotherapy using the Index of Nausea, Vomiting, and Retching (INVR). Receives: Other: Geranium Inhalation Aromatherapy |
| Control (No Aromatherapy) | No intervention | Participants in this arm did not receive any aromatherapy or additional supportive intervention. They underwent chemotherapy according to the standard hospital protocol. Nausea and vomiting were assessed at baseline and 12 hours after chemotherapy using the Index of Nausea, Vomiting, and Retching (INVR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nausea and Vomiting Score (INVR)
The primary outcome is the change in nausea, vomiting, and retching severity measured using the Index of Nausea, Vomiting, and Retching (INVR). INVR scores are collected before chemotherapy (baseline) and 12 hours after chemotherapy. The measure evaluates the effectiveness of geranium inhalation aromatherapy in reducing chemotherapy-induced nausea and vomiting.
Measured: Baseline to 12 hours after chemotherapy
Secondary outcomes (1)
Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV)
The secondary outcome is the proportion of participants experiencing nausea and vomiting after chemotherapy, assessed using INVR categorical scores. This measure compares differences in symptom incidence between the geranium aromatherapy group and the control group
Measured: 12 hours after chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start1 Jan 2024
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Nausea and Vomiting (CINV)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: a geranium aromatherapy group and a control group without aromatherapy.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Surakarta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahrun Nur Rosyid, Universitas Muhammadiyah Surakarta
- Investigators
- Faculty of Health Sciences FIK UMS, Principal investigator, Universitas Muhammadiyah Surakarta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07292831
- Sponsor's protocol ID
- UMS-GERANIUM-RCT2025
- Status last verified
- Dec 2025
- First submitted
- 23 Nov 2025
- Last updated
- 18 Dec 2025
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geranium Inhalation Aromatherapy: An Alternative Therapy to Alleviate Nausea & Vomiting in Cancer Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT07292831
- Acronym / sponsor ID
- UMS-GERANIUM-RCT2025
- Keywords
- Cancer, Chemotherapy, Geranium Aromatherapy, Nausea, Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah SurakartaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 18 Dec 2025 (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.
Chemotherapy-induced nausea and vomiting (CINV) remain among the most distressing side effects experienced by cancer patients and can significantly affect treatment tolerance and quality of life. Geranium essential oil has been proposed as a complementary, non-pharmacological therapy that may help reduce nausea and vomiting through its calming and antiemetic properties.
This randomized controlled trial aims to evaluate the potential effectiveness of geranium inhalation aromatherapy in reducing nausea and vomiting among cancer patients undergoing chemotherapy. Ninety participants undergoing intravenous chemotherapy will be enrolled and randomly assigned to either the geranium aromatherapy group or the control group. The intervention group will receive inhalation of geranium essential oil, while the control group will receive no aromatherapy.Nausea and vomiting will be measured using the validated Index of Nausea, Vomiting, and Retching (INVR) before chemotherapy and 12 hours afterward. This study is designed to explore whether geranium inhalation aromatherapy may serve as a supportive complementary therapy to enhance comfort and overall quality of life for patients undergoing chemotherapy.
Detailed description
Chemotherapy is a primary treatment modality for many types of cancer but is frequently accompanied by adverse effects, particularly nausea and vomiting. These symptoms are triggered by complex interactions between neurotransmitters and receptors in both the gastrointestinal and central nervous systems. Although antiemetic medications have improved over the years, many patients continue to experience discomfort that negatively affects their quality of life. Complementary therapies such as aromatherapy are increasingly explored as supportive approaches to help alleviate these symptoms. Geranium essential oil (Pelargonium graveolens) possesses calming, anti-inflammatory, and potential antiemetic properties. Inhalation aromatherapy is thought to reduce nausea by stimulating olfactory pathways associated with relaxation and autonomic regulation. This study aims to investigate the potential benefit of geranium inhalation aromatherapy as an adjunct to standard chemotherapy care. This randomized controlled trial (RCT) involves 90 cancer patients undergoing intravenous chemotherapy at a public hospital in Surakarta, Indonesia. Participants are selected through simple random sampling. Inclusion criteria include patients aged under 65 years, with a BMI of 18.5-22.9 kg/m², receiving chemotherapy regimen 1, and willing to provide informed consent. Participants will be randomized into two groups: a treatment group receiving geranium inhalation aromatherapy and a control group receiving no aromatherapy. Baseline demographic and clinical characteristics-including age, gender, education level, occupation, body mass index, duration of illness, cancer stage, hemoglobin levels, leukocyte and platelet counts, kidney function, liver function, and chemotherapy status-will be recorded to ensure comparability between groups. Geranium aromatherapy will be administered through inhalation, a method known to deliver rapid olfactory stimulation and promote relaxation. Nausea and vomiting will be assessed using the Index of Nausea, Vomiting, and Retching (INVR), a reliable and widely used instrument for evaluating chemotherapy-related gastrointestinal symptoms. Measurements will be collected at baseline and 12 hours after chemotherapy. This study is expected to provide additional insight into the feasibility, safety, and potential role of aromatherapy-specifically geranium essential oil-in supporting the management of chemotherapy-induced nausea and vomiting as part of a holistic approach to cancer care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: a geranium aromatherapy group and a control group without aromatherapy.
| Arm | Type | Receives |
|---|---|---|
| Geranium Aromatherapy | Experimental | Other: Geranium Inhalation AromatherapyParticipants in this arm received geranium essential oil inhalation aromatherapy during chemotherapy. The aromatherapy was administered by allowing patients to inhale geranium essential oil through a controlled inhalation method. This intervention was provided during the chemotherapy session, and nausea/vomiting levels were assessed before and 12 hours after chemotherapy using the Index of Nausea, Vomiting, and Retching (INVR). |
| Control (No Aromatherapy) | No intervention | –Participants in this arm did not receive any aromatherapy or additional supportive intervention. They underwent chemotherapy according to the standard hospital protocol. Nausea and vomiting were assessed at baseline and 12 hours after chemotherapy using the Index of Nausea, Vomiting, and Retching (INVR). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with cancer.
- Currently undergoing intravenous chemotherapy regimen 1.
- Aged under 65 years.
- Body Mass Index (BMI) between 18.5 and 22.9 kg/m².
- Able and willing to provide informed consent.
Key exclusion criteria (1 listed)
- Known allergy or sensitivity to essential oils or fragrances
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 |
|---|---|---|
| Geranium Inhalation AromatherapyAlso: Geranium Essential Oil, Aromatherapy with Geranium OilParticipants received inhalation aromatherapy using geranium essential oil (Pelargonium graveolens). The essential oil was administered through controlled inhalation during the chemotherapy session. Patients inhaled the aroma directly, allowing olfactory stimulation intended to reduce nausea and vomiting. The intervention was applied according to a standardized protocol, and nausea/vomiting were assessed before and 12 hours after chemotherapy using the Index of Nausea, Vomiting, and Retching (INVR). | Other | Geranium Aromatherapy |
Primary outcome
Change in Nausea and Vomiting Score (INVR)
Time frame: Baseline to 12 hours after chemotherapy
The primary outcome is the change in nausea, vomiting, and retching severity measured using the Index of Nausea, Vomiting, and Retching (INVR). INVR scores are collected before chemotherapy (baseline) and 12 hours after chemotherapy. The measure evaluates the effectiveness of geranium inhalation aromatherapy in reducing chemotherapy-induced nausea and vomiting.
1 secondary outcome
Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV)
Time frame: 12 hours after chemotherapy
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 18 Dec 2025.
- 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. This study is not recruiting at the moment.
Faculty of Health Sciences FIK UMS principal investigator
Universitas Muhammadiyah Surakarta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geranium Inhalation Aromatherapy in people with Chemotherapy-Induced Nausea and Vomiting (CINV) and Cancer, run by Universitas Muhammadiyah Surakarta at 1 site in Indonesia.
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 6 inclusion and 1 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 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. 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. 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?
Change in Nausea and Vomiting Score (INVR) (time frame: Baseline to 12 hours after chemotherapy). 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 18 Dec 2025.