Treatment of Chemotherapy-related Hiccups With Baclofen

Nanchang University

Status and phase: Unknown; Phase 4

Conditions: Hiccup

Treatments: Drug: Methoxyclopramide; Drug: Baclofen

Study type: Interventional

Funder types: Other

Identifiers

NCT03778281

HL002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 4 patient groups

Baclofen group

Experimental group

Description:

Treatment of Chemotherapy-related Hiccups With Baclofen

Treatment:

Drug: Baclofen

Methoxyclopramide group

Other group

Description:

Treatment of Chemotherapy-related Hiccups With Methoxyclopramide

Treatment:

Drug: Methoxyclopramide

Baclofen group 2

Experimental group

Description:

After 3 days, if the metoclopramide treatment is ineffective, it will cross into the baclofen group 2.

Treatment:

Drug: Baclofen

Methoxyclopramide group 2

Other group

Description:

After 3 days, if the baclofen treatment is ineffective, it will cross into the metoclopramide group 2.

Treatment:

Drug: Methoxyclopramide