Treatment of Chemotherapy-related Hiccups With Baclofen

NCT03778281 | Unknown Phase 4

• 1 other identifier: HL002
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hiccup

Keywords

Baclofen; Chemotheropy

Outcome Measures

Primary Outcomes (1)

• Effective rate

  Effective rate includes complete response rate and partial response rate

  3 days

Secondary Outcomes (1)

• Adverse reactions

  3 days

Study Arms (4)

Baclofen group

EXPERIMENTAL

Treatment of Chemotherapy-related Hiccups With Baclofen

Drug: Baclofen

Methoxyclopramide group

OTHER

Treatment of Chemotherapy-related Hiccups With Methoxyclopramide

Drug: Methoxyclopramide

Baclofen group 2

EXPERIMENTAL

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

Drug: Baclofen

Methoxyclopramide group 2

OTHER

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

Drug: Methoxyclopramide

Interventions

Baclofen DRUG

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

Also known as: Baclofenum、Gabalon、Lioresal

Baclofen group; Baclofen group 2

Methoxyclopramide DRUG

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

Also known as: Detoxification

Methoxyclopramide group; Methoxyclopramide group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological diagnosis of malignant tumors;PS score 0 \~ 3 points;
• Hiccups occurred within 48 h after chemotherapy, lasting longer than 2 h.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Nanchang University: lead

MeSH Terms

Conditions

Hiccup

Interventions

Baclofen; Inactivation, Metabolic

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biotransformation; Metabolism; Pharmacokinetics; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• long Huang, Phd

  Second Affiliated Hospital of Nanchang University

  STUDY DIRECTOR

Central Study Contacts

long Huang, Phd

CONTACT

13699549060; ndefy13211@ncu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient privacy needs to be protected
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: December 19, 2018
• Study Start: December 12, 2018
• Primary Completion: December 11, 2019
• Study Completion: December 20, 2019
• Last Updated: December 19, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share