The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

The Effect of Breathing Exercise on Chemotherapy-induced Nausea and Vomiting in With Autologous Hematopoietic Stem Cell Transplantation Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05311371
• Other study ID #: 2022.065.IRB1.034
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: March 1, 2023

Study information

• Verified date: March 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Other:
• Breathing exercise group
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 group
No intervention

Locations

Country	Name	City	State
Turkey	Koç University Hospital	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)	Koc University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. — View 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 20 — View Citation

Haiderali 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/s — View 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. — View 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 Consen — View 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.

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Daily Nutritional Consumption Amount Form	The amount of consumption of the patient in the morning, lunch, evening and snacks will be recorded before the treatment and throughout the study. The patient's antiemetic treatment, enteral and parenteral nutrition will be recorded daily in the follow-up form.	Baseline and 14 days
Other	Patient Nausea And Vomiting Episode Follow-Up Form	This follow-up chart was created by the researcher in order to evaluate the severity and episode of nausea and vomiting symptom during chemotherapy treatment and post-transplantation in patients with autologous hematopoietic stem cell transplantation. The scale consists of a 100 mm/10 cm long horizontal line. On the left end of the line, there is 0 "No nausea" statement, while on the right end there is 10 "Nausea is very severe" statement.; The patient will be asked to mark the point on the line that will accurately reflect his or her nausea state. In addition, the patient will be asked to write down the number of nausea and vomiting numerically.	Baseline and 14 days
Primary	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.	Baseline
Secondary	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.	Baseline and 14 days