- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07322393
Effect of Foot Reflexology On Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients
Effect of Foot Reflexology On Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted to assess the effectiveness of foot reflexology in reducing chemotherapy-induced nausea and vomiting among breast cancer patients receiving chemotherapy. Eligible participants will be adult breast cancer patients undergoing scheduled chemotherapy treatment.
After enrollment, participants will be randomly assigned into two groups: an experimental group and a control group. The experimental group will receive foot reflexology in addition to standard chemotherapy care, while the control group will receive standard care only.
Foot reflexology will be administered by the researcher using a standardized technique. Each session will last approximately 20-30 minutes and will be provided during chemotherapy sessions across multiple chemotherapy cycles with an interval of 21 days. Reflex points associated with nausea, vomiting, relaxation, and digestion will be stimulated using appropriate pressure techniques.
Nausea and vomiting will be assessed using a standardized assessment tool before and after the intervention during each chemotherapy cycle. The collected data will be analyzed to compare the severity of nausea and vomiting between the experimental and control groups to determine the effectiveness of foot reflexology as a supportive therapy for managing chemotherapy-induced nausea and vomiting.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dania A Khan, MSN
- Phone Number: +923408380021
- Email: asadamzhr93@gmail.com
Study Contact Backup
- Name: Nusrat Hussain, MSN
- Phone Number: +9203085182487
- Email: hussainnusrat640@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Breast Cancer patients aged >18 Patients receiving chemotherapy in curative setting
Exclusion Criteria:
Patients with paraplegia. Patients with skin ulcers or wounds. Patients with psychiatric conditions. Patients with foot fractures and varicose veins. Patients with GIT and Liver Cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Foot Reflexology plus Standard Care
Participants in this arm will receive foot reflexology in addition to standard chemotherapy care.
Foot reflexology will be administered by the researcher using a standardized technique during chemotherapy sessions.
Each session will last approximately 20-30 minutes and will be provided during each chemotherapy cycle with a 21-day interval.
Standard care will be provided as per hospital protocol.
|
Foot reflexology is a complementary therapy involving the application of pressure to specific reflex points on the feet associated with nausea, vomiting, relaxation, and digestion.
The intervention will be administered by the researcher for 20-30 minutes during chemotherapy sessions using a standardized technique.
|
|
No Intervention: Standard Care
Participants in this arm will receive standard chemotherapy care as per hospital protocol.
No foot reflexology intervention will be provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of Chemotherapy-Induced Nausea and Vomiting
Time Frame: From baseline to end of each chemotherapy cycle (up to four cycles, 21 days apart)
|
The severity of chemotherapy-induced nausea and vomiting will be assessed using the Rhodes Index of Nausea, Vomiting and Retching (RINVR), a validated scale measuring the frequency, severity, and distress of nausea and vomiting.
Scores range from low to high, with higher scores indicating more severe symptoms.
Measurements will be recorded before and after the intervention during each chemotherapy cycle.
|
From baseline to end of each chemotherapy cycle (up to four cycles, 21 days apart)
|
Collaborators and Investigators
Investigators
- Study Chair: DR. Kausar Bano, MBBS, FCPS, Jinnah Hospital Lahore
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAKhan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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