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Treatment of Chemotherapy-related Hiccups With Baclofen

NCT ID: NCT03778281

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2019-12-20

Brief Summary

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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

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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.

Conditions

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Hiccup

Keywords

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Baclofen Chemotheropy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Patient privacy needs to be protected

Study Groups

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Baclofen group

Treatment of Chemotherapy-related Hiccups With Baclofen

Group Type EXPERIMENTAL

Baclofen

Intervention Type DRUG

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

Methoxyclopramide group

Treatment of Chemotherapy-related Hiccups With Methoxyclopramide

Group Type OTHER

Methoxyclopramide

Intervention Type DRUG

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

Baclofen group 2

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

Group Type EXPERIMENTAL

Baclofen

Intervention Type DRUG

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

Methoxyclopramide group 2

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

Group Type OTHER

Methoxyclopramide

Intervention Type DRUG

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

Interventions

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Baclofen

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

Intervention Type DRUG

Methoxyclopramide

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

Intervention Type DRUG

Other Intervention Names

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Baclofenum、Gabalon、Lioresal Detoxification

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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long Huang, Phd

Role: STUDY_DIRECTOR

Second Affiliated Hospital of Nanchang University

Central Contacts

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long Huang, Phd

Role: CONTACT

Phone: 13699549060

Email: [email protected]

Other Identifiers

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HL002

Identifier Type: -

Identifier Source: org_study_id