Clinical trial NCT03778281: Treatment of Chemotherapy-related Hiccups With Baclofen
Official title: Open-label Randomized Controlled Prospective Study of Baclofen in the Treatment of Chemotherapy-related Hiccups
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hiccup
Keywords: Baclofen
Chemotheropy
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effective rate
timeFrame: 3 days
Secondary outcomes:
measure: Adverse reactions
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital of Nanchang University
name: long Huang, Phd
role: STUDY_DIRECTOR
References: