Complementary Effect of Reflexology on Chemotherapy-Induc... | NCT02653820

Studies
Complementary Effect of Reflexology on Chemotherapy-Induced Nausea and Vomiting

NCT02653820

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jan 12, 2016Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Reflexology

Interventions

Reflexology

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2016

Primary Completion Date

Feb 2018Estimated

Completion Date

Feb 2018Estimated

First Submitted Date

Jan 6, 2016

First Submission Date that Met QC Criteria

Jan 10, 2016

First Posted Date

Jan 12, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2016

Last Update Posted Date

Jan 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chemotherapy patients	Experimental	Chemotherapy patients will receive reflexology treatment	Other: Reflexology

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Reflexology	Other		Chemotherapy patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Severity of Nausea	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	Vomiting will be assessed both before after three weeks of reflexology treatment by Common Toxicity Criteria Adverse Events Tool	Three weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chemotherapy patients

Exclusion Criteria:

Myocardial Infarction in previous 6 months
Mechanical colonic obstruction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katerina Shulman, MD	Contact	972-4-6188280		katerinas@hy.health.gov.il

Overall Officials

Name	Affiliation	Role
Katerina Shulman, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera		38100	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026201	Musculoskeletal Manipulations

Ancestor Terms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided