- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02653820
Complementary Effect of Reflexology on Chemotherapy-Induced Nausea and Vomiting
January 10, 2016 updated by: Hillel Yaffe Medical Center
Reflexology treatment may influence the severity of chemotherapy-induced nausea and vomiting.
This study aims to investigate the clinical effect of reflexology on chemotherapy-induced nausea and vomiting.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Katerina Shulman, MD
- Phone Number: 972-4-6188280
- Email: katerinas@hy.health.gov.il
Study Locations
-
-
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Hadera, Israel, 38100
- Hillel Yaffe Medical Center
-
Contact:
- Katerina Shulman, MD
- Phone Number: 972-4-6188280
- Email: katerinas@hy.health.gov.il
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chemotherapy patients
Exclusion Criteria:
- Myocardial Infarction in previous 6 months
- Mechanical colonic obstruction
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chemotherapy patients
Chemotherapy patients will receive reflexology treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Severity of Nausea
Time Frame: Three weeks
|
Nausea will be assessed both before after three weeks of reflexology treatment by Common Toxicity Criteria Adverse Events Tool
|
Three weeks
|
Change in Severity of Vomiting
Time Frame: Three weeks
|
Vomiting will be assessed both before after three weeks of reflexology treatment by Common Toxicity Criteria Adverse Events Tool
|
Three weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Katerina Shulman, MD, Hillel Yaffe Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Anticipated)
February 1, 2018
Study Completion (Anticipated)
February 1, 2018
Study Registration Dates
First Submitted
January 6, 2016
First Submitted That Met QC Criteria
January 10, 2016
First Posted (Estimate)
January 12, 2016
Study Record Updates
Last Update Posted (Estimate)
January 12, 2016
Last Update Submitted That Met QC Criteria
January 10, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 102-15 HYMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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