Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 3:53 AM
Study NCT ID:
NCT07322393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Foot Reflexology On Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study as blinding of participants and the researcher is not feasible due to the nature of the intervention.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-12-22', 'studyFirstSubmitQcDate': '2025-12-22', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Chemotherapy-Induced Nausea and Vomiting', 'timeFrame': 'From baseline to end of each chemotherapy cycle (up to four cycles, 21 days apart)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Nausea and Vomiting']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://journals.ekb.eg/article_293709_2ae2feb1a5ac3b48491377622893f2e3.pdf', 'label': 'Article:Effect of Foot Reflexology on Chemotherapy Induced Nausea and Vomiting among Cancer Patients'}, {'url': 'https://cyprusjmedsci.com/articles/the-impact-of-foot-reflexology-on-nausea-vomiting-and-sleep-quality-for-lung-cancer-patients-receiving-chemotherapy-in-turkey/doi/cjms.2022.2021-227', 'label': 'Article: The Impact of Foot Reflexology on Nausea-Vomiting and Sleep Quality for Lung Cancer Patients Receiving Chemotherapy in Turkey'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nAfter 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.\n\nFoot 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.\n\nNausea 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBreast Cancer patients aged \\>18 Patients receiving chemotherapy in curative setting\n\nExclusion Criteria:\n\nPatients 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'}, 'identificationModule': {'nctId': 'NCT07322393', 'briefTitle': 'Effect of Foot Reflexology On Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Health Sciences Lahore'}, 'officialTitle': 'Effect of Foot Reflexology On Chemotherapy Induced Nausea and Vomiting in Breast Cancer Patients: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DAKhan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Foot Reflexology plus Standard Care', 'description': '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.', 'interventionNames': ['Other: Foot Reflexology']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Participants in this arm will receive standard chemotherapy care as per hospital protocol. No foot reflexology intervention will be provided.'}], 'interventions': [{'name': 'Foot Reflexology', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Foot Reflexology plus Standard Care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dania A Khan, MSN', 'role': 'CONTACT', 'email': 'asadamzhr93@gmail.com', 'phone': '+923408380021'}, {'name': 'Nusrat Hussain, MSN', 'role': 'CONTACT', 'email': 'hussainnusrat640@gmail.com', 'phone': '+9203085182487'}], 'overallOfficials': [{'name': 'DR. Kausar Bano, MBBS, FCPS', 'role': 'STUDY_CHAIR', 'affiliation': 'Jinnah Hospital Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Health Sciences Lahore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSN Student', 'investigatorFullName': 'Dania Azher Khan', 'investigatorAffiliation': 'University of Health Sciences Lahore'}}}}