NCT07322393

Brief Summary

This study aims to evaluate the effect of foot reflexology on chemotherapy-induced nausea and vomiting in breast cancer patients. Nausea and vomiting are common side effects of chemotherapy and can negatively affect patients' comfort and quality of life. Foot reflexology is a non-invasive complementary therapy that involves applying pressure to specific points on the feet. The study will compare patients who receive foot reflexology along with standard care to those who receive standard care alone, to determine whether foot reflexology helps reduce the severity of nausea and vomiting during chemotherapy.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

December 22, 2025

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Severity of Chemotherapy-Induced Nausea and Vomiting

    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)

Study Arms (2)

Foot Reflexology plus Standard Care

EXPERIMENTAL

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.

Other: Foot Reflexology

Standard Care

NO INTERVENTION

Participants in this arm will receive standard chemotherapy care as per hospital protocol. No foot reflexology intervention will be provided.

Interventions

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.

Foot Reflexology plus Standard Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast Cancer patients aged \>18 Patients receiving chemotherapy in curative setting

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • DR. Kausar Bano, MBBS, FCPS

    Jinnah Hospital Lahore

    STUDY CHAIR

Central Study Contacts

Dania A Khan, MSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study as blinding of participants and the researcher is not feasible due to the nature of the intervention.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an experimental group receiving foot reflexology in addition to standard care or a control group receiving standard care alone. Both groups will be followed in parallel throughout the study period.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSN Student

Study Record Dates

First Submitted

December 22, 2025

First Posted

January 7, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

August 2, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share