LeukemiaNCT06095726
Peppermint Inhalation Versus Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia
A study testing Peppermint Inhalation and Swedish Massage in people with Leukemia, run by Alexandria University at 1 site in Egypt.
Trial summary
Clinical trials was used to compare the effect of peppermint inhalation and Swedish massage on chemotherapy induced-nausea and vomiting in children with leukemia. the main research hypotheses are: Children with leukemia who receive peppermint inhalation exhibit less chemotherapy induced- nausea and vomiting than those… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Peppermint Inhalation and Swedish Massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 31 Dec 2022
- 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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Received first chemotherapy session
- Intact skin in the massage
Who cannot join
- Chronic and acute disorders such as respiratory, cardiovascular diseases...etc.
- Allergy from any essential oils.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of Peppermint Inhalation and Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia.
Clinical trials was used to compare the effect of peppermint inhalation and Swedish massage on chemotherapy induced-nausea and vomiting in children with leukemia. the main research hypotheses are:
- Children with leukemia who receive peppermint inhalation exhibit less chemotherapy induced- nausea and vomiting than those who don't receive.
- Children with leukemia who receive Swedish massage exhibit less chemotherapy induced-nausea and vomiting than those who don't receive.
- Children with leukemia who receive Swedish massage exhibit less chemotherapy induced- nausea and vomiting than those who receive peppermint inhalation. children divided into three groups of study ( control group, peppermint inhalation group and Swedish massage group) to identify its effect on chemotherapy induced nausea and vomiting.
- Conditions
- Leukemia
- Being tested
- Peppermint Inhalation, Swedish Massage
- Keywords
- leukemia, Swedish Massage, Peppermint Inhalation, Nausea, Vomiting, Chemotherapy, Children
- Medical subject headings
- Leukemia, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint InhalationBehavioural
The researcher applied two drops (0,2ml) of 2% essential oil of peppermint on a piece of cotton. Then, each child was instructed to take three breaths of the essence that had been put on a piece of cotton before starting chemotherapy session with three minutes. In addition, the piece of cotton with peppermint essence was kept at bed side table to use by child as needed throughout the chemotherapy session. Inhalation of peppermint essence was applied for three consecutive chemotherapy sessions.
Swedish MassageBehavioural
Children were received Swedish massage therapy for twenty minutes prior to chemotherapy session in a private and special room with effleurage, petrissage, friction, and tapotement and vibration movements for three consecutive chemotherapy sessions. The researcher applied facilitating olive oil in hands and pre warmed before applying massage. The massage technique was applied in prone position with mild to moderate pressure with guidance by the child's feedback and tolerance by using non-scented olive oil. Children's privacy was considered.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Children with leukemia received routine nursing and hospital care for management of chemotherapy induced nausea and vomiting (antiemetic medications only). |
| Peppermint Inhalation Group | Experimental | Children with leukemia received the inhalation of essential oil of peppermint 2% in addition to routine nursing and hospital care for management of chemotherapy induced nausea and vomiting. Receives: Behavioral: Peppermint Inhalation |
| Swedish Massage Group: | Experimental | Children with leukemia received the Swedish massage therapy in addition to routine nursing and hospital care for management of chemotherapy induced nausea and vomiting. Receives: Behavioral: Swedish Massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of anticipatory nausea
Yes/No
Measured: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Worst of anticipatory nausea
No/Mild/Moderate/severe/intolerable
Measured: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Duration of anticipatory nausea
/Minutes
Measured: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Frequency of anticipatory nausea
once/twice/ three times and more
Measured: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Experience of anticipatory vomiting
Yes/No
Measured: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Worst of anticipatory vomiting
No/Mild/Moderate/severe/intolerable
Measured: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Amount of anticipatory vomiting
Small/ Moderate/ Large
Measured: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Frequency of anticipatory vomiting
once/ twice/ three times and more.
Measured: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Experience of acute nausea .
Yes/no.
Measured: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Worst of acute nausea .
No/Mild/Moderate/severe/intolerable
Measured: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Duration of acute nausea .
/hours.
Measured: Frst 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Frequency of acute nausea .
once/ twice/ three times and more.
Measured: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Experience of acute vomiting.
Yes/No.
Measured: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Worst of acute vomiting.
No/Mild/Moderate/severe/intolerable
Measured: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Amount of acute vomiting.
Small/ Moderate/ large
Measured: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Frequency of acute vomiting.
once/ twice/ three times and more.
Measured: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Experience of delayed nausea.
Yes/ No.
Measured: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Worst of delayed nausea.
No/Mild/Moderate/severe/intolerable
Measured: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Duration of delayed nausea.
/hours.
Measured: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Frequency of delayed nausea.
once/ twice/ three times and more.
Measured: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Experience of delayed vomiting.
Yes/ No.
Measured: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Worst of delayed vomiting.
No/Mild/Moderate/severe/intolerable
Measured: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Amount of delayed vomiting.
Small/ Moderate/ large
Measured: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Frequency of delayed vomiting.
once/ twice/ three times and more.
Measured: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095726
- Sponsor's protocol ID
- CINV
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sowmiya Rajendran, Ruthrani Princely J, Kanchana S, Celina D., Effectiveness of Swedish Massage on the Level of Chemotherapy Induced Nausea and Vomiting (CINV) Among Children with Cancer at a Selected Hospital in North India, ICCRJNR, Jul - Dec 2016, 1(2): 20-38.
Evans A, Malvar J, Garretson C, Pedroja Kolovos E, Baron Nelson M. The Use of Aromatherapy to Reduce Chemotherapy-Induced Nausea in Children With Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):392-398. doi: 10.1177/1043454218782133. Epub 2018 Jun 27.
PubMed 29947285El-SayedYousef, Y., Zaki, N. A., AsmaaAbd-Alasis, Abdel-RazikSayed, H., & Elsayed, F. (2018). Effect of Therapeutic Massage on nausea and vomitingamong Children with Leukemia following Chemotherapy.
Ahmad, M. (2016). Tool Development to Assess Nausea and Vomiting Among Patients Receiving Chemotherapy. International Journal of Cancer and Oncology, 3(1), 1-5. https://doi.org/10.15436/2377-0902.16.031
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of Peppermint Inhalation and Swedish Massage on Chemotherapy Induced-Nausea and Vomiting in Children With Leukemia.
- ClinicalTrials.gov ID
- NCT06095726
- Acronym / sponsor ID
- CINV
- Conditions
- Leukemia
- Keywords
- leukemia, Swedish Massage, Peppermint Inhalation, Nausea, Vomiting, Chemotherapy, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 23 Oct 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.
Clinical trials was used to compare the effect of peppermint inhalation and Swedish massage on chemotherapy induced-nausea and vomiting in children with leukemia. the main research hypotheses are:
- Children with leukemia who receive peppermint inhalation exhibit less chemotherapy induced- nausea and vomiting than those who don't receive.
- Children with leukemia who receive Swedish massage exhibit less chemotherapy induced-nausea and vomiting than those who don't receive.
- Children with leukemia who receive Swedish massage exhibit less chemotherapy induced- nausea and vomiting than those who receive peppermint inhalation. children divided into three groups of study ( control group, peppermint inhalation group and Swedish massage group) to identify its effect on chemotherapy induced nausea and vomiting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Children with leukemia received routine nursing and hospital care for management of chemotherapy induced nausea and vomiting (antiemetic medications only). |
| Peppermint Inhalation Group | Experimental | Behavioral: Peppermint InhalationChildren with leukemia received the inhalation of essential oil of peppermint 2% in addition to routine nursing and hospital care for management of chemotherapy induced nausea and vomiting. |
| Swedish Massage Group: | Experimental | Behavioral: Swedish MassageChildren with leukemia received the Swedish massage therapy in addition to routine nursing and hospital care for management of chemotherapy induced nausea and vomiting. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Received first chemotherapy session
- Intact skin in the massage
Key exclusion criteria (2 listed)
- Chronic and acute disorders such as respiratory, cardiovascular diseases...etc.
- Allergy from any essential oils.
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 |
|---|---|---|
| Peppermint InhalationThe researcher applied two drops (0,2ml) of 2% essential oil of peppermint on a piece of cotton. Then, each child was instructed to take three breaths of the essence that had been put on a piece of cotton before starting chemotherapy session with three minutes. In addition, the piece of cotton with peppermint essence was kept at bed side table to use by child as needed throughout the chemotherapy session. Inhalation of peppermint essence was applied for three consecutive chemotherapy sessions. | Behavioural | Peppermint Inhalation Group |
| Swedish MassageChildren were received Swedish massage therapy for twenty minutes prior to chemotherapy session in a private and special room with effleurage, petrissage, friction, and tapotement and vibration movements for three consecutive chemotherapy sessions. The researcher applied facilitating olive oil in hands and pre warmed before applying massage. The massage technique was applied in prone position with mild to moderate pressure with guidance by the child's feedback and tolerance by using non-scented olive oil. Children's privacy was considered. | Behavioural | Swedish Massage Group: |
Primary outcome
Experience of anticipatory nausea
Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Yes/No
Worst of anticipatory nausea
Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
No/Mild/Moderate/severe/intolerable
Duration of anticipatory nausea
Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
/Minutes
Frequency of anticipatory nausea
Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
once/twice/ three times and more
Experience of anticipatory vomiting
Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Yes/No
Worst of anticipatory vomiting
Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
No/Mild/Moderate/severe/intolerable
Amount of anticipatory vomiting
Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
Small/ Moderate/ Large
Frequency of anticipatory vomiting
Time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions
once/ twice/ three times and more.
Experience of acute nausea .
Time frame: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Yes/no.
Worst of acute nausea .
Time frame: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
No/Mild/Moderate/severe/intolerable
Duration of acute nausea .
Time frame: Frst 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
/hours.
Frequency of acute nausea .
Time frame: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
once/ twice/ three times and more.
Experience of acute vomiting.
Time frame: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Yes/No.
Worst of acute vomiting.
Time frame: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
No/Mild/Moderate/severe/intolerable
Amount of acute vomiting.
Time frame: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
Small/ Moderate/ large
Frequency of acute vomiting.
Time frame: First 24 hours after first chemotherapy administration of study. Assessed within the first 24 hours after second chemotherapy administration of study. Assessed within the first 24 hours after third chemotherapy administration of study.
once/ twice/ three times and more.
Experience of delayed nausea.
Time frame: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Yes/ No.
Worst of delayed nausea.
Time frame: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
No/Mild/Moderate/severe/intolerable
Duration of delayed nausea.
Time frame: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
/hours.
Frequency of delayed nausea.
Time frame: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
once/ twice/ three times and more.
Experience of delayed vomiting.
Time frame: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Yes/ No.
Worst of delayed vomiting.
Time frame: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
No/Mild/Moderate/severe/intolerable
Amount of delayed vomiting.
Time frame: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
Small/ Moderate/ large
Frequency of delayed vomiting.
Time frame: On second and third days after first chemotherapy administration.On second and third days after second chemotherapy administration. On second and third days after third chemotherapy administration.
once/ twice/ three times and more.
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 23 Oct 2023.
- BackgroundSowmiya Rajendran, Ruthrani Princely J, Kanchana S, Celina D., Effectiveness of Swedish Massage on the Level of Chemotherapy Induced Nausea and Vomiting (CINV) Among Children with Cancer at a Selected Hospital in North India, ICCRJNR, Jul - Dec 2016, 1(2): 20-38.
- Background: PubMed 29947285Evans A, Malvar J, Garretson C, Pedroja Kolovos E, Baron Nelson M. The Use of Aromatherapy to Reduce Chemotherapy-Induced Nausea in Children With Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):392-398. doi: 10.1177/1043454218782133. Epub 2018 Jun 27.
- BackgroundEl-SayedYousef, Y., Zaki, N. A., AsmaaAbd-Alasis, Abdel-RazikSayed, H., & Elsayed, F. (2018). Effect of Therapeutic Massage on nausea and vomitingamong Children with Leukemia following Chemotherapy.
- Results publicationAhmad, M. (2016). Tool Development to Assess Nausea and Vomiting Among Patients Receiving Chemotherapy. International Journal of Cancer and Oncology, 3(1), 1-5. https://doi.org/10.15436/2377-0902.16.031
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peppermint Inhalation and Swedish Massage in people with Leukemia, run by Alexandria University at 1 site in Egypt.
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 2 inclusion and 2 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 23 Oct 2023. 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 Egypt. 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?
Experience of anticipatory nausea (time frame: assessed immediately before chemotherapy administration for three consecutive chemotherapy sessions). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06095726, which also lists 4 linked publications.
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 23 Oct 2023.