NCT02653820

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

January 6, 2016

Last Update Submit

January 10, 2016

Conditions

Reflexology

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Chemotherapy patients

EXPERIMENTAL

Chemotherapy patients will receive reflexology treatment

Other: Reflexology

Interventions

ReflexologyOTHER
Chemotherapy patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chemotherapy patients

You may not qualify if:

  • Myocardial Infarction in previous 6 months
  • Mechanical colonic obstruction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Katerina Shulman, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katerina Shulman, MD

CONTACT

972-4-6188280katerinas@hy.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 12, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

January 12, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)