MucositisPhase 3NCT04988971
The Efficacy and Safety of a Compound Glutamine Capsule in the Prevention of Chemotherapy-induced Mucositis
A Phase 3 study testing a compound glutamine capsule in people with Mucositis and Chemotherapeutic Toxicity, run by Meng Qiu at 1 site in China.
Trial summary
Chemotherapy regimens not only improve the survival of patients with gastric cancer and colorectal cancer, but also cause obvious adverse reactions of digestive tract, such as chemotherapy-induced oral mucositis, abdominal pain, diarrhea, constipation and so on. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mucositis, Chemotherapeutic Toxicity
- What is being tested?
- a compound glutamine capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2021to 31 Dec 2022
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old; Sex: Male or female;
- Pathologically confirmed gastric adenocarcinoma or colorectal adenocarcinoma;
- Patients who had received standard chemotherapy containing platinum or irinotecan developed grade 1-3 (NCI-CTCAE, version4.0) diarrhea in the previous cycle and recovered to grade 0 after symptomatic treatment;
- Patients are planned to receive the same chemotherapy regimen and dose as the previous cycle;
- A baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Adequate haematopoietic function of bone marrow: neutrophils≥1.5x109 / L, platelets≥75x109 / L; normal liver and kidney function: TBIL≤ 1 upper limit of normal (ULN); ALT and AST ≤2.5 ULN; creatinine≤1.5 ULN;
- Estimated life expectancy ≥ 3 months;
- Be willing and able to provide written informed consent for the trial.
Who cannot join
- (Patient-Generated Subjective Global Assessment, PG-SGA)>9 or severe malnutrition (weight loss > 10% or serum albumin < 30 g/L or body mass index < 18.5 kg/m2);
- Patients with severe heart, lung and brain diseases; chronic hepatitis infection, liver cirrhosis, chronic nephritis, kidney dysfunction, etc;
- Patients with infection-related fever;
- Patients who are known to be allergic or intolerant to any of the ingredients used in the study;
- Patients with long-term chronic diarrhea, abdominal pain, constipation or other digestive tract diseases; patients with gastrointestinal symptoms before chemotherapy (≥grade 2 NCI-CTCAE, version 4.0);
- Synchronously receive other treatments that may cause diarrhea, such as radiotherapy;
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- Patients who take drugs for microecological regulation of digestive tract such as Combined Bifidobacterium, ChangTai oral liquid, etc;
- Patients take traditional Chinese medicine or antibiotics;
- Unable to understand and sign the informed consent form;
- participants in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Meng Qiu
Sichuan
meng qiu, 18980601776, qiumeng@wchscu.cn
About this study
Official title: The Efficacy and Safety of a Compound Glutamine Capsule in the Prevention of Chemotherapy-induced Mucositis in Patients With Gastrointestinal Tumors: a Prospective, Randomized, Controlled, Double-blind, Phase III Clinical Study
Chemotherapy regimens not only improve the survival of patients with gastric cancer and colorectal cancer, but also cause obvious adverse reactions of digestive tract, such as chemotherapy-induced oral mucositis, abdominal pain, diarrhea, constipation and so on. These adverse reactions seriously affect the patients' quality of life and the efficacy of chemotherapy. Glutamine is a conditionally essential amino acid in the human body. Previous studies have shown that oral glutamine can help to keep the integrity of mucosal epithelium during chemotherapy and reduce the gastrointestinal side effects caused by chemotherapy. The addition of glutamine to parenteral nutrition can better maintain nitrogen balance and reduce the incidence of infection-related complications. A compound glutamine capsule, composed of L-glutamine and the traditional Chinese herbal formula Si-Jun-Zi-Tang which composed of ginseng, Atractylodes macrocephala, Poria cocos and licorice, has been widely used in China for 23 years to treat many types of gastrointestinal diseases, including gastrointestinal reactions induced by radiotherapy and chemotherapy, ulcerative colitis, irritable bowel syndrome. However, so far, only a small sample of clinical trials have explored the role of glutamine in chemical mucositis, and there is a lack of prospective randomized controlled clinical trials to further verify its value in the prevention and treatment of chemical mucositis. The purpose of this study is to observe the efficacy and safety between a compound glutamine capsule and placebo in the prevention of chemotherapy-induced mucositis in patients with gastric cancer and colorectal cancer in a prospective, randomized, double-blind clinical trial.
- Conditions
- Mucositis, Chemotherapeutic Toxicity
- Being tested
- a compound glutamine capsule, a compound glutamine capsule simulated placebo
- Medical subject headings
- Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a compound glutamine capsuleDrug
A compound glutamine capsule was taken orally from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
a compound glutamine capsule simulated placeboDrug
a compound glutamine capsule simulated placebo was taken orally from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Experimental | during the current cycle of chemotherapy (need to be the same regimens as the previous cycle of chemotherapy, the same dose), patients take a compound glutamine capsules, from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks. Receives: Drug: a compound glutamine capsule |
| Group D | Placebo comparator | during the current cycle of chemotherapy (need to be the same regimens as the previous cycle of chemotherapy, the same dose), patients take a compound glutamine capsule simulated placebo, from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks. Receives: Drug: a compound glutamine capsule simulated placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1 (according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0)
Measured: At the end of Cycle 1(each cycle is 14/21 days)
Secondary outcomes (2)
Overall incidence of gastrointestinal adverse events except diarrhea ≥ grade 1
Overall incidence of gastrointestinal adverse events except diarrhea ≥ grade 1 (including oral mucositis, nausea, vomiting, abdominal pain, stomachache, and other types, according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0)
Measured: At the end of Cycle 1(each cycle is 14/21 days)
Overall incidence of grade 3/4 gastrointestinal adverse events
Overall incidence of grade 3/4 gastrointestinal adverse events according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0
Measured: At the end of Cycle 1(each cycle is 14/21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start30 Jun 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meng Qiu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Meng Qiu, West China Hospital
- Investigators
- meng qiu, Doctor, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988971
- Sponsor's protocol ID
- 2021615
- Status last verified
- Oct 2021
- First submitted
- 12 Jul 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of a Compound Glutamine Capsule in the Prevention of Chemotherapy-induced Mucositis in Patients With Gastrointestinal Tumors: a Prospective, Randomized, Controlled, Double-blind, Phase III Clinical Study
- ClinicalTrials.gov ID
- NCT04988971
- Acronym / sponsor ID
- 2021615
- Conditions
- Mucositis, Chemotherapeutic Toxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Meng QiuUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 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.
Chemotherapy regimens not only improve the survival of patients with gastric cancer and colorectal cancer, but also cause obvious adverse reactions of digestive tract, such as chemotherapy-induced oral mucositis, abdominal pain, diarrhea, constipation and so on. These adverse reactions seriously affect the patients' quality of life and the efficacy of chemotherapy. Glutamine is a conditionally essential amino acid in the human body. Previous studies have shown that oral glutamine can help to keep the integrity of mucosal epithelium during chemotherapy and reduce the gastrointestinal side effects caused by chemotherapy. The addition of glutamine to parenteral nutrition can better maintain nitrogen balance and reduce the incidence of infection-related complications. A compound glutamine capsule, composed of L-glutamine and the traditional Chinese herbal formula Si-Jun-Zi-Tang which composed of ginseng, Atractylodes macrocephala, Poria cocos and licorice, has been widely used in China for 23 years to treat many types of gastrointestinal diseases, including gastrointestinal reactions induced by radiotherapy and chemotherapy, ulcerative colitis, irritable bowel syndrome. However, so far, only a small sample of clinical trials have explored the role of glutamine in chemical mucositis, and there is a lack of prospective randomized controlled clinical trials to further verify its value in the prevention and treatment of chemical mucositis. The purpose of this study is to observe the efficacy and safety between a compound glutamine capsule and placebo in the prevention of chemotherapy-induced mucositis in patients with gastric cancer and colorectal cancer in a prospective, randomized, double-blind clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Experimental | Drug: a compound glutamine capsuleduring the current cycle of chemotherapy (need to be the same regimens as the previous cycle of chemotherapy, the same dose), patients take a compound glutamine capsules, from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks. |
| Group D | Placebo comparator | Drug: a compound glutamine capsule simulated placeboduring the current cycle of chemotherapy (need to be the same regimens as the previous cycle of chemotherapy, the same dose), patients take a compound glutamine capsule simulated placebo, from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18-75 years old; Sex: Male or female;
- Pathologically confirmed gastric adenocarcinoma or colorectal adenocarcinoma;
- Patients who had received standard chemotherapy containing platinum or irinotecan developed grade 1-3 (NCI-CTCAE, version4.0) diarrhea in the previous cycle and recovered to grade 0 after symptomatic treatment;
- Patients are planned to receive the same chemotherapy regimen and dose as the previous cycle;
- A baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Key exclusion criteria (10 listed)
- (Patient-Generated Subjective Global Assessment, PG-SGA)>9 or severe malnutrition (weight loss > 10% or serum albumin < 30 g/L or body mass index < 18.5 kg/m2);
- Patients with severe heart, lung and brain diseases; chronic hepatitis infection, liver cirrhosis, chronic nephritis, kidney dysfunction, etc;
- Patients with infection-related fever;
- Patients who are known to be allergic or intolerant to any of the ingredients used in the study;
- Patients with long-term chronic diarrhea, abdominal pain, constipation or other digestive tract diseases; patients with gastrointestinal symptoms before chemotherapy (≥grade 2 NCI-CTCAE, version 4.0);
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 |
|---|---|---|
| a compound glutamine capsuleA compound glutamine capsule was taken orally from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks. | Drug | Group C |
| a compound glutamine capsule simulated placeboa compound glutamine capsule simulated placebo was taken orally from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks. | Drug | Group D |
Primary outcome
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1
Time frame: At the end of Cycle 1(each cycle is 14/21 days)
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1 (according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0)
2 secondary outcomes
Overall incidence of gastrointestinal adverse events except diarrhea ≥ grade 1
Time frame: At the end of Cycle 1(each cycle is 14/21 days)
Overall incidence of grade 3/4 gastrointestinal adverse events
Time frame: At the end of Cycle 1(each cycle is 14/21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
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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.
meng qiu, Doctor study chair
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing a compound glutamine capsule in people with Mucositis and Chemotherapeutic Toxicity, run by Meng Qiu 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 8 inclusion and 10 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 15 Oct 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 meng qiu, Doctor (18980601776, qiumeng@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall incidence of chemotherapy-induced diarrhea ≥ grade 1 (time frame: At the end of Cycle 1(each cycle is 14/21 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 15 Oct 2021.