Treatment of Chemotherapy-related Hiccups With Baclofen

Hiccup Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03778281
• Other study ID #: HL002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 12, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: December 2018
• Source: Second Affiliated Hospital of Nanchang University
• Contact: long Huang, Phd
• Phone: 13699549060
• Email: ndefy13211[@]ncu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 20, 2019
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hiccup

Intervention

Drug:
• Baclofen
Oral baclofen 10mg, 3 times a day for three days, then evaluate the efficacy and side effects
• Methoxyclopramide
Intramuscular injection of metoclopramide 10mg, 3 times a day for three days, then evaluate the efficacy and side effects

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effective rate	Effective rate includes complete response rate and partial response rate	3 days
Secondary	Adverse reactions	Adverse reactions include drowsiness, dizziness, sedation, tremors, etc.	3 days