Patients who receive the first cycle of intravenous chemotherapy in hospitals will be randomly assigned in two groups and followed in two courses. In the first course of chemotherapy the patients in group one, receive oxygen therapy during chemotherapy and patients in group two receive the routine care. In the second course of chemotherapy with the same drugs, the patients in group one receive routine care and the patients in group two receive oxygen therapy during chemotherapy. The severity of nausea and vomiting will be assessed for all of patients and compared with each others.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305226481N4
Registration date:2013-06-02, 1392/03/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-02, 1392/03/12
Registrant information
Name
Mohsen Soleimani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
soli257@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oxygen therapy during chemotherapy on severity of chemotherapy-induced nausea and vomiting.
Public title
The effect of oxygen therapy during chemotherapy on nausea and vomiting.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria:
1- First cycle of chemotherapy
2- Use of intravenous chemotherapeutic agents with moderate and severe effect of nausea and vomiting
3- Administration to hospital for chemotherapy
4- Ability to communication
5- Literate
Exclusion Criteria:
1- Psychiatric disorders
2- Gastrointestinal and brain malignancy
3- Electrolyte imbalance
4- Metabolic disorders that caused nausea and vomiting
5- Drug abuse and Alcohol
6- Use of opioid drugs with self-control pump
7- Simultaneous radiotherapy
8- Disorders in inner ear
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Semnan, Iran.
City
Semnan,
Postal code
3513138111
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
17m15-32-92
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C00-C97
ICD-10 code description
Malignant neoplasms
Primary outcomes
1
Description
Nausea and Vomiting
Timepoint
pre and post intervention in two groups
Method of measurement
The Index of Nausea, Vomiting and Retching (INVR)
Secondary outcomes
1
Description
Quality of life related to nausea and vomiting
Timepoint
Pre and post intervention in two groups
Method of measurement
The Osoba’ Nausea and Emesis Module
Intervention groups
1
Description
Oxygen therapy 5 lit/min with simple face mask during chemotherapy.