Treatment of Chemotherapy-related Hiccups With Baclofen

Brief Title

Treatment of Chemotherapy-related Hiccups With Baclofen

Official Title

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

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Effective rate

Secondary Outcome

 Adverse reactions

Condition

Hiccup

Intervention

Baclofen

Study Arms / Comparison Groups

 Baclofen group
Description:  Treatment of Chemotherapy-related Hiccups With Baclofen

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

December 12, 2018

Completion Date

December 20, 2019

Primary Completion Date

December 11, 2019

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.
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

long Huang, Phd, 13699549060, [email protected]



Administrative Informations


NCT ID

NCT03778281

Organization ID

HL002


Responsible Party

Sponsor

Study Sponsor

Second Affiliated Hospital of Nanchang University


Study Sponsor

long Huang, Phd, Study Director, Second Affiliated Hospital of Nanchang University


Verification Date

December 2018