Complementary Effect of Reflexology on Chemotherapy-Induced Nausea and Vomiting

• Sponsor: Hillel Yaffe Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02653820
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Reflexology	Other: Reflexology	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Study Start Date: Feb 1, 2016
• Anticipated Primary Completion Date: Feb 1, 2018
• Anticipated Study Completion Date: Feb 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Chemotherapy patients Chemotherapy patients will receive reflexology treatment	Other: Reflexology

Outcome Measures

Primary Outcome Measures

1. Change in Severity of Nausea [Three weeks]

   Nausea will be assessed both before after three weeks of reflexology treatment by Common Toxicity Criteria Adverse Events Tool

2. Change in Severity of Vomiting [Three weeks]

   Vomiting will be assessed both before after three weeks of reflexology treatment by Common Toxicity Criteria Adverse Events Tool

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chemotherapy patients

Exclusion Criteria:

• Myocardial Infarction in previous 6 months

• Mechanical colonic obstruction

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hillel Yaffe Medical Center	Hadera		Israel	38100

Sponsors and Collaborators

• Hillel Yaffe Medical Center

Investigators

• Principal Investigator: Katerina Shulman, MD, Hillel Yaffe Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hillel Yaffe Medical Center
• ClinicalTrials.gov Identifier: NCT02653820
• Other Study ID Numbers: 102-15 HYMC
• First Posted: Jan 12, 2016
• Last Update Posted: Jan 12, 2016
• Last Verified: Jan 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

No Results Posted as of Jan 12, 2016