TRANSCUTANEOUS ELECTRICAL ACUPOINT STIMULATION FOR CISPLATIN- CHEMOTHERAPY INDUCED NAUSEA AND VOMITING

The purpose of this study is to evaluate the therapeutic efficacy of transcutaneous electrical acupoint stimulation for cisplatin- chemotherapy induced nausea and vomiting.

Study Overview

• Status: Completed
• Conditions: Vomiting; Acupuncture; Transcutaneous Electrical Acupoint Stimulation; Nausea Post Chemotherapy
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation; Drug: Antiemetic

Detailed Description

Chemotherapy-induced nausea and vomiting significantly impacts the quality of life for 70%-80% of cancer patients receiving chemotherapy. The P6 acupressure point is traditionally used to relieve these symptoms and has shown benefits in pain relief and other conditions. If studies on Transcutaneous electrical acupoint stimulation yield positive results, it could be integrated as an effective method to manage chemotherapy-induced nausea and vomiting, enhancing patient comfort and treatment outcomes while potentially reducing the need for dosage adjustments. This study aims to address gaps in current treatments, improving management and quality of life for affected cancer patients.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Damietta, Egypt
    • National Cancer Institute in Damietta.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male and female patients who their ages between 40 and 60.
• All patients diagnosed with cancer and planned to receive TACE treatment with cisplatin (60 mg) as the main drug. The chemotherapy regimen will not include steroids.
• Karnofsky's score ≥60.
• All patients will receive the same antiemetic drug.
• None of them receiving other physical therapy modalities to treat nausea and vomiting.
• The skin of acupoint site receiving electrical acupoint stimulation must be intact and without visible evidence of injury
• All patient can tolerate mild discomfort following electrical stimulation.
• All patients enrolled in the study will have their informed consent.

Exclusion Criteria:

• Combined use of other venous chemotherapy within 5 days after Transarterial Chemoembolization
• Other confounding factors that may cause nausea and vomiting (such as intestinal obstruction, anorexia, and so on)
• Having vomited or used 5 HT3 receptor antagonists or other antiemetics within 24 hours before Transarterial Chemoembolization .
• Receiving concurrent radiotherapy
• Severe uncontrolled complications and unstable metastases
• Installing pacemaker, Pregnancy.
• History of convulsions or seizure disorder.
• Cognitive dysfunction, unable to finish Scale
• Transcutaneous electrical acupoint stimulation treatment within the past year regardless of indication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous electrical nerve stimulation group; this group is going to take Transcutaneous electrical nerve stimulation at acupoint P6 and IL4 in additional to traditional anti-emetic drugs	Device: Transcutaneous electrical nerve stimulation; The acupoints were wiped with a moist cotton swab and then connected to the anode and cathode of the electrical stimulation generator through an electrode patch placed on the skin surface. Continuous wave form mode was selected, and then the electric current produced continuous stimulation on the acupoints. Stimulation frequency was set at 4 Hz, and the default value was set as 10 mA, which was twice the sensory threshold (5 mA). The intensity was adjusted every 10 min to keep the patients comfortable, and its actual value ranged from 7 to 15 mA.; Drug: Antiemetic; the drug is being taken once a day for 72 hours after introducing chemotherapy
Active Comparator: Traditional Group; this group is going to receive traditional anti-emetic drug	Drug: Antiemetic; the drug is being taken once a day for 72 hours after introducing chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of nausea	The M. D. Anderson Symptom Inventory MD Anderson Symptom Inventory is a multi-symptom patient-reported outcome measure for clinical and research use. The MD Anderson Symptom Inventory 's thirteen core items include symptoms found to have the highest frequency and/or severity in patients with various cancers and treatment types. Each symptom is being scored between 0 and 10, were 0 means no effect and 10 means greatest severity.	At the day of chemotherapy administration and the following 5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of vomiting	Visual analog scale for anorexia is a widely used tool for assessing subjective symptoms, including anorexia. It consists of a horizontal or vertical line, typically 100 mm long, where patients mark their perceived intensity of a symptom-ranging from "no anorexia" to "worst possible anorexia"	At the day of chemotherapy administration and the following 5 days

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Actual): January 20, 2026
• Study Completion (Actual): February 18, 2026

Study Registration Dates

• First Submitted: March 28, 2026
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vomiting; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Therapeutics; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Physical Therapy Modalities; Rehabilitation; Anesthesia and Analgesia; Electric Stimulation Therapy; Central Nervous System Agents; Analgesia; Antiemetics; Transcutaneous Electric Nerve Stimulation
• Other Study ID Numbers: Nourhan-M.Sc

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No