Chemotherapy-induced Nausea and VomitingNCT07322393
Effect of Foot Reflexology On Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients
A study testing Foot Reflexology in people with Chemotherapy-induced Nausea and Vomiting, run by University of Health Sciences Lahore.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chemotherapy-induced Nausea and Vomiting
- What is being tested?
- Foot Reflexology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast Cancer patients aged >18 Patients receiving chemotherapy in curative setting
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Foot Reflexology On Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Being tested
- Foot Reflexology
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot ReflexologyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to end of each chemotherapy cycle (up to four cycles, 21 days apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Jun 2026 (estimated)
- Primary completion2 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by University of Health Sciences LahoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Health Sciences Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dania Azher Khan, University of Health Sciences Lahore
- Investigators
- DR. Kausar Bano, MBBS, FCPS, Study chair, Jinnah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322393
- Sponsor's protocol ID
- DAKhan
- Status last verified
- Apr 2026
- First submitted
- 22 Dec 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Foot Reflexology On Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07322393
- Acronym / sponsor ID
- DAKhan
- Conditions
- Chemotherapy-induced Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Health Sciences LahoreUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 2 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Foot Reflexology plus Standard Care | Experimental | Other: Foot ReflexologyParticipants 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. |
| Standard Care | No intervention | –Participants in this arm will receive standard chemotherapy care as per hospital protocol. No foot reflexology intervention will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast Cancer patients aged >18 Patients receiving chemotherapy in curative setting
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foot ReflexologyFoot 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. | Other | Foot Reflexology plus Standard Care |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Article:Effect of Foot Reflexology on Chemotherapy Induced Nausea and Vomiting among Cancer PatientsLink provided by the sponsor.
- Article: The Impact of Foot Reflexology on Nausea-Vomiting and Sleep Quality for Lung Cancer Patients Receiving Chemotherapy in TurkeyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chemotherapy-induced Nausea and Vomiting
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RecruitingObservational study
HR20013 for the Prevention of Nausea and Vomiting in Patients With Cancer: A Real-World Study
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RecruitingPhase 1
A Study to Compare the Bioavailability of Ondansetron Following Nasal (NS003) and IV Administration in Healthy Adults
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DR. Kausar Bano, MBBS, FCPS study chair
Jinnah Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Foot Reflexology in people with Chemotherapy-induced Nausea and Vomiting, run by University of Health Sciences Lahore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dania A Khan, MSN (+923408380021, asadamzhr93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Chemotherapy-Induced Nausea and Vomiting (time frame: From baseline to end of each chemotherapy cycle (up to four cycles, 21 days apart)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.