Clinical trial NCT05311371: The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients
Official title: The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy-induced Nausea and Vomiting
Keywords: Nausea
Vomiting
Breathing exercise
Autologous Hematopoietic Stem Cell Transplantation
Chemotherapy
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
Collaborators: name: Koc University Hospital
First posted: 2022-04-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Patient Information Form
timeFrame: Baseline
Secondary outcomes:
measure: Rhodes Index of Nausea, Vomiting ve Retching
timeFrame: Baseline and 14 days
Other outcomes:
measure: Daily Nutritional Consumption Amount Form
timeFrame: Baseline and 14 days
measure: Patient Nausea And Vomiting Episode Follow-Up Form
timeFrame: Baseline and 14 days
Locations:
city: Istanbul
country: Turkey
facility: Koç University Hospital
Study officials:
References:
citation: 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.
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citation: Roila 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.
citation: Rapoport 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.
citation: Aybar 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.
citation: Suryono 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.
citation: 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.