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Treatment of Chemotherapy-related Hiccups With Baclofen

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03778281
Enrollment
120
Registered
2018-12-19
Start date
2018-12-12
Completion date
2019-12-20
Last updated
2018-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiccup

Keywords

Baclofen, Chemotheropy

Brief 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.

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.

Interventions

DRUGBaclofen

Oral baclofen 10mg, 3 times a day for three days, then evaluate the efficacy and side effects

DRUGMethoxyclopramide

Intramuscular injection of metoclopramide 10mg, 3 times a day for three days, then evaluate the efficacy and side effects

Sponsors

Second Affiliated Hospital of Nanchang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Patient privacy needs to be protected

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Effective rate3 daysEffective rate includes complete response rate and partial response rate

Secondary

MeasureTime frameDescription
Adverse reactions3 daysAdverse reactions include drowsiness, dizziness, sedation, tremors, etc.

Contacts

Primary Contactlong Huang, Phd
ndefy13211@ncu.edu.cn13699549060

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026