Chemotherapy-induced Nausea and VomitingNCT05311371
The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients
A study testing Breathing exercise group in people with Chemotherapy-induced Nausea and Vomiting, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Nausea and vomiting are serious problems in patients undergoing autologous stem cell transplantation. It is stated that the incidence of acute and delayed nausea and vomiting is more than 50%, even if the patient has been given antiemetic prophylaxis during the treatment process. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Breathing exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Mar 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Least 18-years-old,
- Autologous hematopoietic stem cell transplantation and take high-dose chemotherapy,
- not have any communicative problems,
- not have Coronavirus disease (COVID-19) disease or respiratory disease,
- Hb value of 10 and above and
- knowing how to read, write, and speak Turkish
Who cannot join
- have respiratory disease and Coronavirus disease (COVID-19),
- having any communication and psychiatric problem,
- not knowing how to read, write, and speak Turkish,
- not wanting to participate in the study and have anemia.
Trial locations and contacts
1 site in 1 country.
About this study
Nausea and vomiting are serious problems in patients undergoing autologous stem cell transplantation. It is stated that the incidence of acute and delayed nausea and vomiting is more than 50%, even if the patient has been given antiemetic prophylaxis during the treatment process.
Breathing is the easiest relaxation exercise applied during the flow in everyday life and also one of the most important and essential parts of other relaxation exercise. The handbooks prepared for the patients undergoing chemotherapy recommend deep breathing exercises in order to prevent their nausea and vomiting.
Read more
The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.
Research Hypotheses Ho: Respiratory exercise is not effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.
H1: Respiratory exercise is effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.
In the literature, no study has been found investigating the effect of breathing exercises on chemotherapy-induced nausea and vomiting for autologous hematopoietic stem cell transplantation patients.
The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Breathing exercise group, Control group
- Keywords
- Nausea, Vomiting, Breathing exercise, Autologous Hematopoietic Stem Cell Transplantation, Chemotherapy
- Medical subject headings
- Vomiting, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exercise groupOther
The exercise was applied in accordance with the "Guideline on Breathing Exercise for Reducing Nausea and Vomiting" prepared by the researcher in accordance with the literature. In addition, the researcher has a breath coaching certificate. The guideline include the application steps of breathing exercise. First, the researcher will demonstrate to the patients the practice of breathing exercise in accordance with the guideline. In the next step, patients they will be asked to do this application on themselves. The training is planned to take about 15-20 minutes for each patient. This guide will be given to patients after the training. They will be asked to do this breathing exercise correctly and effectively in accordance with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days. The researcher will follow up the patients for 14 days by visiting room them every day.
Control groupOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Breathing exercise group | Experimental | The researcher will collect the data using Patient Information Form, Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form through face-to-face interview technique on the first day and for 14 days.
During chemotherapy and stem cell transplantation, antiemetic treatment included in the treatment protocol will be applied to the patients.
The patients will train about the application of breathing exercise by the researcher. They will be asked to do this breathing exercise with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days. Receives: Other: Breathing exercise group |
| Control group | Other | The researcher will collect the data using Patient Information Form, Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form through face-to-face interview technique on the first day. The researcher will continue to fill out Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form for 14 days.
During chemotherapy and stem cell transplantation, antiemetic treatment included in the treatment protocol will be applied to the patients. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Information Form
Patient Information Form is a form prepared to determine the sociodemographic and disease-related characteristics of the patients. Sociodemographic characteristics of patient are composed of height, age, weight, educational status, social security, occupation, marital status, nutritional habits, smoking and alcohol use. Patient Information Form have general information about the patients such as diagnosis, duration, stage, and metastasis status of the disease, antiemetic drugs and treatment history. Disease history of cancer is , nausea-vomiting complaints before chemotherapy, the presence of any non-pharmacological method used to reduce nausea and vomiting induced by chemotherapy drugs.
Measured: Baseline
Secondary outcomes (1)
Rhodes Index of Nausea, Vomiting ve Retching
Responses to each item are classified by using expressions appropriate to the item and scoring the severity of the nausea-vomiting-retching experience from 0 to 4. There are eight items in this scale that evaluate the experience, frequency and distress of nausea-vomiting and retching. The increase in score reflects worsening of the complaint experienced.
Measured: Baseline and 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Feb 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Koc University Hospital
- Responsible party
- Principal investigator, ZELİHA GENÇ, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05311371
- Sponsor's protocol ID
- 2022.065.IRB1.034
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H. Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer. 2007 May;15(5):497-503. doi: 10.1007/s00520-006-0173-z. Epub 2006 Nov 14.
PubMed 17103197Haiderali A, Menditto L, Good M, Teitelbaum A, Wegner J. Impact on daily functioning and indirect/direct costs associated with chemotherapy-induced nausea and vomiting (CINV) in a U.S. population. Support Care Cancer. 2011 Jun;19(6):843-51. doi: 10.1007/s00520-010-0915-9. Epub 2010 Jun 9.
PubMed 20532923Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, Clark-Snow RA, Dupuis LL, Einhorn LH, Feyer P, Hesketh PJ, Jordan K, Olver I, Rapoport BL, Roscoe J, Ruhlmann CH, Walsh D, Warr D, van der Wetering M; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. doi: 10.1093/annonc/mdw270. No abstract available.
PubMed 27664248Rapoport BL. Delayed Chemotherapy-Induced Nausea and Vomiting: Pathogenesis, Incidence, and Current Management. Front Pharmacol. 2017 Jan 30;8:19. doi: 10.3389/fphar.2017.00019. eCollection 2017.
PubMed 28194109Aybar DO, Kilic SP, Cinkir HY. The effect of breathing exercise on nausea, vomiting and functional status in breast cancer patients undergoing chemotherapy. Complement Ther Clin Pract. 2020 Aug;40:101213. doi: 10.1016/j.ctcp.2020.101213. Epub 2020 Jun 14.
PubMed 32891289Suryono A., Akbar F., Nugraha F.S., Armiyati Y. Combination of of deep breathing relaxation and murottal reducing post chemotherapy nausea intensity in nasopharyngeal cancer (NPC) patients, Media Keperawatan Indonesia. 2020; 3: 24-31.
Yoo HJ, Ahn SH, Kim SB, Kim WK, Han OS. Efficacy of progressive muscle relaxation training and guided imagery in reducing chemotherapy side effects in patients with breast cancer and in improving their quality of life. Support Care Cancer. 2005 Oct;13(10):826-33. doi: 10.1007/s00520-005-0806-7. Epub 2005 Apr 23.
PubMed 15856335
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients
- ClinicalTrials.gov ID
- NCT05311371
- Acronym / sponsor ID
- 2022.065.IRB1.034
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Keywords
- Nausea, Vomiting, Breathing exercise, Autologous Hematopoietic Stem Cell Transplantation, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Koc University Hospital
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 5 Apr 2022 (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.
Nausea and vomiting are serious problems in patients undergoing autologous stem cell transplantation. It is stated that the incidence of acute and delayed nausea and vomiting is more than 50%, even if the patient has been given antiemetic prophylaxis during the treatment process.
Breathing is the easiest relaxation exercise applied during the flow in everyday life and also one of the most important and essential parts of other relaxation exercise. The handbooks prepared for the patients undergoing chemotherapy recommend deep breathing exercises in order to prevent their nausea and vomiting.
The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.
Research Hypotheses Ho: Respiratory exercise is not effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.
H1: Respiratory exercise is effective in preventing chemotherapy-associated nausea and vomiting in autologous hematopoietic stem cell transplant patients.
In the literature, no study has been found investigating the effect of breathing exercises on chemotherapy-induced nausea and vomiting for autologous hematopoietic stem cell transplantation patients.
The aim of this study is to determine the effect of respiratory exercise on chemotherapy-induced nausea and vomiting in patients with autologous hematopoietic stem cell transplantation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Breathing exercise group | Experimental | Other: Breathing exercise groupThe researcher will collect the data using Patient Information Form, Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form through face-to-face interview technique on the first day and for 14 days. During chemotherapy and stem cell transplantation, antiemetic treatment included in the treatment protocol will be applied to the patients. The patients will train about the application of breathing exercise by the researcher. They will be asked to do this breathing exercise with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days. |
| Control group | Other | Other: Control groupThe researcher will collect the data using Patient Information Form, Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form through face-to-face interview technique on the first day. The researcher will continue to fill out Rhodes Index of Nausea, Vomiting and Retching Scale, Patient Diary for determining the number of nausea, vomiting, and retching episodes and the hours of breathing exercise of the patient, and Daily Nutritional Consumption Amount Form for 14 days. During chemotherapy and stem cell transplantation, antiemetic treatment included in the treatment protocol will be applied to the patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Least 18-years-old,
- Autologous hematopoietic stem cell transplantation and take high-dose chemotherapy,
- not have any communicative problems,
- not have Coronavirus disease (COVID-19) disease or respiratory disease,
- Hb value of 10 and above and
Key exclusion criteria (4 listed)
- have respiratory disease and Coronavirus disease (COVID-19),
- having any communication and psychiatric problem,
- not knowing how to read, write, and speak Turkish,
- not wanting to participate in the study and have anemia.
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 |
|---|---|---|
| Breathing exercise groupThe exercise was applied in accordance with the "Guideline on Breathing Exercise for Reducing Nausea and Vomiting" prepared by the researcher in accordance with the literature. In addition, the researcher has a breath coaching certificate. The guideline include the application steps of breathing exercise. First, the researcher will demonstrate to the patients the practice of breathing exercise in accordance with the guideline. In the next step, patients they will be asked to do this application on themselves. The training is planned to take about 15-20 minutes for each patient. This guide will be given to patients after the training. They will be asked to do this breathing exercise correctly and effectively in accordance with the guideline for at least 5 min in case of sensation of nausea and vomiting for 14 days. The researcher will follow up the patients for 14 days by visiting room them every day. | Other | Breathing exercise group |
| Control groupNo intervention | Other | Control group |
Primary outcome
Patient Information Form
Time frame: Baseline
Patient Information Form is a form prepared to determine the sociodemographic and disease-related characteristics of the patients. Sociodemographic characteristics of patient are composed of height, age, weight, educational status, social security, occupation, marital status, nutritional habits, smoking and alcohol use. Patient Information Form have general information about the patients such as diagnosis, duration, stage, and metastasis status of the disease, antiemetic drugs and treatment history. Disease history of cancer is , nausea-vomiting complaints before chemotherapy, the presence of any non-pharmacological method used to reduce nausea and vomiting induced by chemotherapy drugs.
1 secondary outcome
Rhodes Index of Nausea, Vomiting ve Retching
Time frame: Baseline and 14 days
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 6 Mar 2024.
- Results publication: PubMed 17103197Cohen L, de Moor CA, Eisenberg P, Ming EE, Hu H. Chemotherapy-induced nausea and vomiting: incidence and impact on patient quality of life at community oncology settings. Support Care Cancer. 2007 May;15(5):497-503. doi: 10.1007/s00520-006-0173-z. Epub 2006 Nov 14.
- Results publication: PubMed 20532923Haiderali A, Menditto L, Good M, Teitelbaum A, Wegner J. Impact on daily functioning and indirect/direct costs associated with chemotherapy-induced nausea and vomiting (CINV) in a U.S. population. Support Care Cancer. 2011 Jun;19(6):843-51. doi: 10.1007/s00520-010-0915-9. Epub 2010 Jun 9.
- Results publication: PubMed 27664248Roila F, Molassiotis A, Herrstedt J, Aapro M, Gralla RJ, Bruera E, Clark-Snow RA, Dupuis LL, Einhorn LH, Feyer P, Hesketh PJ, Jordan K, Olver I, Rapoport BL, Roscoe J, Ruhlmann CH, Walsh D, Warr D, van der Wetering M; participants of the MASCC/ESMO Consensus Conference Copenhagen 2015. 2016 MASCC and ESMO guideline update for the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting and of nausea and vomiting in advanced cancer patients. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. doi: 10.1093/annonc/mdw270. No abstract available.
- Results publication: PubMed 28194109Rapoport BL. Delayed Chemotherapy-Induced Nausea and Vomiting: Pathogenesis, Incidence, and Current Management. Front Pharmacol. 2017 Jan 30;8:19. doi: 10.3389/fphar.2017.00019. eCollection 2017.
- Results publication: PubMed 32891289Aybar DO, Kilic SP, Cinkir HY. The effect of breathing exercise on nausea, vomiting and functional status in breast cancer patients undergoing chemotherapy. Complement Ther Clin Pract. 2020 Aug;40:101213. doi: 10.1016/j.ctcp.2020.101213. Epub 2020 Jun 14.
- Results publicationSuryono A., Akbar F., Nugraha F.S., Armiyati Y. Combination of of deep breathing relaxation and murottal reducing post chemotherapy nausea intensity in nasopharyngeal cancer (NPC) patients, Media Keperawatan Indonesia. 2020; 3: 24-31.
- Results publication: PubMed 15856335Yoo HJ, Ahn SH, Kim SB, Kim WK, Han OS. Efficacy of progressive muscle relaxation training and guided imagery in reducing chemotherapy side effects in patients with breast cancer and in improving their quality of life. Support Care Cancer. 2005 Oct;13(10):826-33. doi: 10.1007/s00520-005-0806-7. Epub 2005 Apr 23.
- 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.
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 Breathing exercise group in people with Chemotherapy-induced Nausea and Vomiting, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 4 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 6 Mar 2024. 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 Turkey (Türkiye). 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?
Patient Information Form (time frame: Baseline). 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 NCT05311371, which also lists 7 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 6 Mar 2024.