Treatment of Chemotherapy-related Hiccups With Baclofen

Open-label Randomized Controlled Prospective Study of Baclofen in the Treatment of Chemotherapy-related Hiccups

Hiccup is one of the common side effects of chemotherapy. Intractable hiccups seriously affect patients' rest and eating, reduce the quality of life, and increasingly attract the attention of oncologists. At present, drugs or methods for treating chemotherapy-related hiccups are generally ineffective, with short remission time, serious adverse reactions, and unsatisfactory clinical effects. Baclofen produces skeletal muscle relaxation and was originally used in patients with spinal cord injury, and has since been used to treat intractable hiccups caused by diaphragmatic spasm. This study was an open-label, randomized, prospective study comparing the efficacy and adverse effects of baclofen versus metoclopramide in the treatment of chemotherapy-related hiccups. Patients with hiccup after chemotherapy were randomly divided into two groups. One group was treated with baclofen and the other group was treated with metoclopramide. The efficacy and adverse reactions of the two groups were compared.Ineffective in the two groups will cross to another group and then observe the efficacy.

Study Overview

• Status: Unknown
• Conditions: Hiccup
• Intervention / Treatment: Drug: Baclofen; Drug: Methoxyclopramide

Detailed Description

Hiccup is due to paroxysmal paralysis of the diaphragm, sudden inhalation of gas accompanied by rapid glottis closure and a short high-pitched sound, commonly known as "snoring", is one of the common adverse reactions of chemotherapy. Intractable hiccups seriously affect the rest and eating of patients, reduce the quality of life, and increasingly attract the attention of oncologists. At present, the drugs or methods used in the treatment of chemotherapy-related hiccups mainly include chlorpromazine, Ritalin, diazepam, phenacetin, metoclopramide and traditional Chinese medicine, but these drugs or treatments usually have poor efficacy and short remission time. The adverse reactions were serious and the clinical use was not satisfactory. Baclofen is a gamma-aminobutyric acid (GABA) derivative that activates the GABA-β receptor, inhibits the release of excitatory neurotransmitters, and reduces monosynaptic or multisynaptic transmission in the spinal cord. Skeletal muscle relaxation, originally used in patients with spinal cord injury, is gradually used to treat intractable hiccups caused by diaphragmatic spasm.

This study was an open-label, randomized, prospective study comparing the efficacy and adverse effects of baclofen versus metoclopramide in the treatment of chemotherapy-related hiccups. Patients with hiccup after chemotherapy were randomly divided into two groups. One group was treated with baclofen and the other group was treated with metoclopramide. The efficacy and adverse reactions of the two groups were compared.Ineffective in the two groups will cross to another group and then observe the efficacy.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: long Huang, PhD; Phone Number: 13699549060; Email: ndefy13211@ncu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pathological diagnosis of malignant tumors;PS score 0 ~ 3 points;
• Hiccups occurred within 48 h after chemotherapy, lasting longer than 2 h.

Exclusion Criteria:

• No serious heart, brain, lung, kidney and other diseases, no gastrointestinal bleeding, no serious obstacles to blood clotting;
• Blood routine and normal electrolyte of liver and kidney function before chemotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baclofen group; Treatment of Chemotherapy-related Hiccups With Baclofen	Drug: Baclofen; Oral baclofen 10mg, 3 times a day for three days, then evaluate the efficacy and side effects; Other Names: Baclofenum、Gabalon、Lioresal
Other: Methoxyclopramide group; Treatment of Chemotherapy-related Hiccups With Methoxyclopramide	Drug: Methoxyclopramide; Intramuscular injection of metoclopramide 10mg, 3 times a day for three days, then evaluate the efficacy and side effects; Other Names: Detoxification
Experimental: Baclofen group 2; After 3 days, if the metoclopramide treatment is ineffective, it will cross into the baclofen group 2.	Drug: Baclofen; Oral baclofen 10mg, 3 times a day for three days, then evaluate the efficacy and side effects; Other Names: Baclofenum、Gabalon、Lioresal
Other: Methoxyclopramide group 2; After 3 days, if the baclofen treatment is ineffective, it will cross into the metoclopramide group 2.	Drug: Methoxyclopramide; Intramuscular injection of metoclopramide 10mg, 3 times a day for three days, then evaluate the efficacy and side effects; Other Names: Detoxification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effective rate	Effective rate includes complete response rate and partial response rate	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse reactions	Adverse reactions include drowsiness, dizziness, sedation, tremors, etc.	3 days

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Nanchang University
• Investigators: Study Director: long Huang, Phd, Second Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 12, 2018
• Primary Completion (Anticipated): December 11, 2019
• Study Completion (Anticipated): December 20, 2019

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: December 17, 2018
• First Posted (Actual): December 19, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Baclofen; Chemotheropy
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Hiccup; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; GABA Agents; Neuromuscular Agents; Muscle Relaxants, Central; GABA Agonists; GABA-B Receptor Agonists; Baclofen
• Other Study ID Numbers: HL002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No