HiccupPhase 4NCT03778281
Treatment of Chemotherapy-related Hiccups With Baclofen
A Phase 4 study testing Baclofen and Methoxyclopramide in people with Hiccup, run by Second Affiliated Hospital of Nanchang University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hiccup
- What is being tested?
- Baclofen and Methoxyclopramide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2018to 20 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of malignant tumors;PS score 0 ~ 3 points;
- Hiccups occurred within 48 h after chemotherapy, lasting longer than 2 h.
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Open-label Randomized Controlled Prospective Study of Baclofen in the Treatment of Chemotherapy-related Hiccups
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.
Read the 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.
- Conditions
- Hiccup
- Being tested
- Baclofen, Methoxyclopramide
- Keywords
- Baclofen, Chemotheropy
- Medical subject headings
- Hiccup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaclofenDrug
Also called Baclofenum、Gabalon、Lioresal
Oral baclofen 10mg, 3 times a day for three days, then evaluate the efficacy and side effects
MethoxyclopramideDrug
Also called Detoxification
Intramuscular injection of metoclopramide 10mg, 3 times a day for three days, then evaluate the efficacy and side effects
| Study group | Role | What they receive |
|---|---|---|
| Baclofen group | Experimental | Treatment of Chemotherapy-related Hiccups With Baclofen Receives: Drug: Baclofen |
| Methoxyclopramide group | Other | Treatment of Chemotherapy-related Hiccups With Methoxyclopramide Receives: Drug: Methoxyclopramide |
| Baclofen group 2 | Experimental | After 3 days, if the metoclopramide treatment is ineffective, it will cross into the baclofen group 2. Receives: Drug: Baclofen |
| Methoxyclopramide group 2 | Other | After 3 days, if the baclofen treatment is ineffective, it will cross into the metoclopramide group 2. Receives: Drug: Methoxyclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective rate
Effective rate includes complete response rate and partial response rate
Measured: 3 days
Secondary outcomes (1)
Adverse reactions
Adverse reactions include drowsiness, dizziness, sedation, tremors, etc.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start12 Dec 2018 (estimated)
- Primary completion11 Dec 2019 (estimated)
- Study completion20 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HiccupStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- long Huang, Phd, Study director, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778281
- Sponsor's protocol ID
- HL002
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Randomized Controlled Prospective Study of Baclofen in the Treatment of Chemotherapy-related Hiccups
- ClinicalTrials.gov ID
- NCT03778281
- Acronym / sponsor ID
- HL002
- Conditions
- Hiccup
- Keywords
- Baclofen, Chemotheropy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 12 Dec 2018 (estimated)
- Primary completion
- 11 Dec 2019 (estimated)
- Study completion
- 20 Dec 2019 (estimated)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Baclofen group | Experimental | Drug: BaclofenTreatment of Chemotherapy-related Hiccups With Baclofen |
| Methoxyclopramide group | Other | Drug: MethoxyclopramideTreatment of Chemotherapy-related Hiccups With Methoxyclopramide |
| Baclofen group 2 | Experimental | Drug: BaclofenAfter 3 days, if the metoclopramide treatment is ineffective, it will cross into the baclofen group 2. |
| Methoxyclopramide group 2 | Other | Drug: MethoxyclopramideAfter 3 days, if the baclofen treatment is ineffective, it will cross into the metoclopramide group 2. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pathological diagnosis of malignant tumors;PS score 0 ~ 3 points;
- Hiccups occurred within 48 h after chemotherapy, lasting longer than 2 h.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaclofenAlso: Baclofenum、Gabalon、LioresalOral baclofen 10mg, 3 times a day for three days, then evaluate the efficacy and side effects | Drug | Baclofen group, Baclofen group 2 |
| MethoxyclopramideAlso: DetoxificationIntramuscular injection of metoclopramide 10mg, 3 times a day for three days, then evaluate the efficacy and side effects | Drug | Methoxyclopramide group, Methoxyclopramide group 2 |
Primary outcome
Effective rate
Time frame: 3 days
Effective rate includes complete response rate and partial response rate
1 secondary outcome
Adverse reactions
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
long Huang, Phd study director
Second Affiliated Hospital of Nanchang University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baclofen and Methoxyclopramide in people with Hiccup, run by Second Affiliated Hospital of Nanchang University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact long Huang, Phd (13699549060, ndefy13211@ncu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective rate (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.