Diarrhea Caused by Antitumor DrugsPhase 2NCT04988165
Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine
A Phase 2 study testing Traditional Chinese Medicine in people with Diarrhea Caused by Antitumor Drugs, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea Caused by Antitumor Drugs
- What is being tested?
- Traditional Chinese Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2021to 8 Oct 2022
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Meet the following two conditions:
- Planned administration of pyrotinib ≥ 21 days;
- Grade 1-3 diarrhea after taking pyrotinib, and it is planned to continue taking pyrotinib;
- 2. Age ≥ 18 years old;
- 3. ECOG PS 0-2；
- 4. Life expectancy ≥ 6 months;
- 5. Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up
Who cannot join
- <!-- -->
- Those who may be allergic to pyrotinib or excipients;
- It has many factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, etc;
- Patients with biliary obstruction;
- Participate in other diarrhea related clinical trials;
- Female patients during pregnancy and lactation, female patients with fertility and positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptives during the whole test period;
- according to the researchers' judgment, there are serious diseases that endanger the safety of patients, or affect the patients to complete the study (including, but not limited to, severe hypertension and severe diabetes, which can not be controlled by drugs).
- Any other circumstances in which the investigator believes that the patient is not suitable to participate in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Zhanyu Pan, Master, 86-13512035574 ext. 1392029, s0010027@163.com
About this study
Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.
Read the detailed description
Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.
- Conditions
- Diarrhea Caused by Antitumor Drugs
- Being tested
- Traditional Chinese Medicine
- Keywords
- Diarrhea, Pyrotinib, Traditional Chinese Medicine
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese MedicineDrug
It is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Drug: Traditional Chinese Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of grade 3-4 diarrhea
The number of stools per day increased by ≥ 7 compared with baseline; Incontinence, indication of hospitalization; Compared with baseline, the yield of stoma increased significantly; Daily activities are limited.Life threatening diarrhea
Measured: From the beginning of taking traditional Chinese medicine to the 21st day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start8 Oct 2021 (estimated)
- Primary completion8 Oct 2022 (estimated)
- Study completion8 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea Caused by Antitumor DrugsStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zhongsheng tong, doctor, Study director, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988165
- Sponsor's protocol ID
- TCM-padia001
- Status last verified
- Jul 2021
- First submitted
- 31 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD is under construction
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Prevention and Treatment of Pyrotinib Associated Diarrhea With Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT04988165
- Acronym / sponsor ID
- TCM-padia001
- Conditions
- Diarrhea Caused by Antitumor Drugs
- Keywords
- Diarrhea, Pyrotinib, Traditional Chinese Medicine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 8 Oct 2021 (estimated)
- Primary completion
- 8 Oct 2022 (estimated)
- Study completion
- 8 Oct 2022 (estimated)
- First posted
- 3 Aug 2021 (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.
Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.
Detailed description
Pyrotinib is an important drug for the treatment of breast cancer, but the incidence of diarrhea is very high. At present, there is no particularly effective drug for diarrhea induced by pyrotinib. Trying to intervene with traditional Chinese medicine may bring better results to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Traditional Chinese Medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Meet the following two conditions:
- 2. Age ≥ 18 years old;
- 3. ECOG PS 0-2；
- 4. Life expectancy ≥ 6 months;
- 5. Voluntarily join the study, sign informed consent, have good compliance and are willing to cooperate with follow-up
Key exclusion criteria (8 listed)
- <!-- -->
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 |
|---|---|---|
| Traditional Chinese MedicineIt is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy. | Drug | Treatment arm |
Primary outcome
incidence of grade 3-4 diarrhea
Time frame: From the beginning of taking traditional Chinese medicine to the 21st day
The number of stools per day increased by ≥ 7 compared with baseline; Incontinence, indication of hospitalization; Compared with baseline, the yield of stoma increased significantly; Daily activities are limited.Life threatening diarrhea
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: Undecided. IPD is under construction
Related trials for Diarrhea Caused by Antitumor Drugs
RecruitingPhase 1
KAN-004 for Immune-Related Diarrhea or Colitis
Colitis, Diarrhea Caused by Antitumor Drugs
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.
zhongsheng tong, doctor study director
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Traditional Chinese Medicine in people with Diarrhea Caused by Antitumor Drugs, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 7 inclusion and 8 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 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 zhansheng jiang, doctor (022-23340123-1101, zhjiang@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of grade 3-4 diarrhea (time frame: From the beginning of taking traditional Chinese medicine to the 21st day). 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 11 Aug 2021.