Oral Mucositis in Patients Undergoing HSCTPhase 3mucositisNCT01797952
A Phase III Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantation
A Phase 3 study testing Lactobacillus CD 2 in people with Oral Mucositis in Patients Undergoing HSCT, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The study will be conducted at departments of Medical Oncology and Hematology, All India Institute of Medical Sciences (AIIMS). Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cells transplant (blood and marrow transplant) have very high chances of developing severe oral… Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Oral Mucositis in Patients Undergoing HSCT
- What is being tested?
- Lactobacillus CD 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2015to Dec 2016
- 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 10 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 10 and 70 years.
- Karnofsky Performance Score ≥ 70%.
- Confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is as approved modality of therapy.
- Patients eligible to receive high-dose chemotherapy as part of conditioning regime.
- Concomitant co morbid condition if present, controlled by medicines.
- Serum creatinine upto 1.8mg/dl.
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- Total bilirubin 2mg/dl.
- Liver enzymes within three times of normal limit.
- Expected survival > 6 months.
Who cannot join
- Pregnant women and lactating mothers.
- Patients with history of AIDS
- Patients who have taken any other investigational product in last 4 weeks.
- Patients having untreated symptomatic dental infection.
- Patients with WHO Grade 3 or 4 oral Mucositis.
- Other serious concurrent illness.
Show all 10Show fewer
- Inconclusive histological diagnosis.
- Patients on anticancer antibiotics.
- Patients with signs and symptoms of systemic infections.
- Patient's/guardian's refusal to sign informed consent.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute Rotary Cancer Hospital,All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Official title: A Randomized Double Blind Placebo Controlled Phase III Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantation
The study will be conducted at departments of Medical Oncology and Hematology, All India Institute of Medical Sciences (AIIMS).
Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cells transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (generally 60-80% in different studies and our own previous experiences). This not only causes significant morbidity but also hampers quality of life needing use of parenteral nutrition, analgesics, and antibiotics.
Read more
No definite treatment exists for prevention or treatment of oral mucositis in this group of patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth factor) will reduce duration and severity. Palifermin is very expensive and not available in country. Recently investigators have shown effectiveness of a probiotic Lactobacillus CD 2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck squamous cell cancer patients. (Published online in European Journal of Cancer: http://dx.doi.org/10.1016/j.ejca.2011.06.010)European Journal of Cancer 2012;4:875-881.No significant toxicity has been reported with its use.
A pilot study on similar aspect was completed recently at our center(Clinical trial.gov identifier:NCT 01480011) and in 31 patients who received this only 6 (20%) developed grade III or IV Mucositis. Now, investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing myeloablative hematopoietic stem cell transplantation. The study drug and placebo will be supplied by CD Pharma India Private Limited.
Investigators further give undertaking that study will be carried as per GCP and declaration of Helsinki.
Read the detailed description
Study Design Placebo controlled double blind randomized, multi center clinical trial.
Study Population and Number of Subjects Total of 108 patients undergoing myeloablative allogeneic or autologous hematopoietic stem cell transplantation and receiving high-dose chemotherapy as conditioning regimen at AIIMS (departments of Medical Oncology and Hematology) will be enrolled for the study and will be equally divided in two groups (drug and placebo).
Study Center The study will be carried at Departments of Medical Oncology and Hematology of All India Institute of Medical Sciences, New Delhi, India.
More centers are likely to be added.
Study Objectives To test whether the probiotic Lactobacillus CD2 (drug) lozenges can reduce the incidence and severity of conditioning therapy induced oral mucositis in patients undergoing haematopoietic stem cell transplantation.
Investigational Product Drug: The trial medication is in the form of lozenge, which is supposed to be dissolved by itself in mouth.
It contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient.
Placebo: The placebo is a mix of sugars and salts used as excipients in the active formulation.
Note: Placebo and drug lozenges will be similar in physical appearance and color.
Dose of Study drug The daily dose of trial medications will be 4-6 lozenges per day, one lozenge to be taken every 2-3 hours preferably not before the meal. The lozenge should be kept in mouth for it to dissolve by itself. A hot beverage (e.g. tea, coffee, milk etc.) should not be taken for at least half an hour before and after the medication since elevated temperature can inactivate the bacteria.
Duration of treatment The treatment will start 4-7 days before starting chemotherapy for conditioning regime of HSCT and will continue till resolution of mucositis or Day+24 post stem cell infusion which-ever is earlier.
Efficacy Assessments
Clinical activity will be defined as reduction in the incidence and severity of chemotherapy induced mucositis in HSCT patients. Most recent version of CTCAE; clinical score of CTC V4.03 ( as also outlined in CTCAE version 3.0) will be used for mucositis assessment. Also,WHO and Oral Mucositis assessment score will be recorded. The study will have the following primary and secondary endpoints:
Primary endpoint
- Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups.
Secondary endpoint
- Determine the incidence of all Grade of mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation in two groups.
- Duration of and time period for healing of chemotherapy induced oral mucositis.
- Determine incidence and severity of dysphagia and requirement of IV antibiotics in two groups
Safety Assessments
- Medical History
- Physical Examination
- Vital Signs (blood pressure, pulse rate and respiratory rate)
- Laboratory Examinations
- Adverse Events
- Being tested
- Lactobacillus CD 2, Placebo
- Keywords
- lactobacillus CD 2, oral mucositis, hematopoietic stem cell transplantation
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus CD 2Drug
2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient
PlaceboOther
The placebo is a mix of sugars and salts used as excipients in the active formulation
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus CD 2 lozenges | Active comparator | 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient Receives: Drug: Lactobacillus CD 2; Other: Placebo |
| Placebo lozenges | Placebo comparator | The placebo is a mix of sugars and salts used as excipients in the active formulation Receives: Drug: Lactobacillus CD 2; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of mucositis grade(Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO)
- Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups
Measured: Day 0-Days 24
Secondary outcomes (3)
Incidence,duration and time period of mucositis Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO)
- Determine the incidence of all Grade of mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation in two groups (Criteria for assessment is given in Appendix 1).
Measured: Day 0-Days 24
Incidence,duration and time period of mucositis Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO)
Duration of and time period for healing of chemotherapy induced oral mucositis.
Measured: Day0- days 24
Incidence,duration and time period of mucositis Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO)
Determine incidence and severity of dysphagia and requirement of IV antibiotics in two groups
Measured: day 0- days 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2013 (estimated)
- Study startNov 2015
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Why it stopped: PI was away on sabbatical for 2 years.Protocol is being revised before starting the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Mucositis in Patients Undergoing HSCTStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Atul Sharma, All India Institute of Medical Sciences
- Investigators
- Atul Sharma, MD,DM, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01797952
- Sponsor's protocol ID
- P 1201
- Acronym
- mucositis
- Status last verified
- Nov 2016
- First submitted
- 19 Feb 2013
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sharma A, Rath GK, Chaudhary SP, Thakar A, Mohanti BK, Bahadur S. Lactobacillus brevis CD2 lozenges reduce radiation- and chemotherapy-induced mucositis in patients with head and neck cancer: a randomized double-blind placebo-controlled study. Eur J Cancer. 2012 Apr;48(6):875-81. doi: 10.1016/j.ejca.2011.06.010. Epub 2011 Jul 6.
PubMed 21741230
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Placebo Controlled Phase III Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-Dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Myeloablative Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01797952
- Acronym / sponsor ID
- mucositis / P 1201
- Keywords
- lactobacillus CD 2, oral mucositis, hematopoietic stem cell transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI was away on sabbatical for 2 years.Protocol is being revised before starting the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Feb 2013 (estimated)
- 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.
The study will be conducted at departments of Medical Oncology and Hematology, All India Institute of Medical Sciences (AIIMS).
Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cells transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (generally 60-80% in different studies and our own previous experiences). This not only causes significant morbidity but also hampers quality of life needing use of parenteral nutrition, analgesics, and antibiotics.
No definite treatment exists for prevention or treatment of oral mucositis in this group of patients. Though one study has suggested that use of IV palifermin (a keratinocyte growth factor) will reduce duration and severity. Palifermin is very expensive and not available in country. Recently investigators have shown effectiveness of a probiotic Lactobacillus CD 2 in reducing incidence and severity of chemo-radiotherapy induced mucositis in head and neck squamous cell cancer patients. (Published online in European Journal of Cancer: http://dx.doi.org/10.1016/j.ejca.2011.06.010)European Journal of Cancer 2012;4:875-881.No significant toxicity has been reported with its use.
A pilot study on similar aspect was completed recently at our center(Clinical trial.gov identifier:NCT 01480011) and in 31 patients who received this only 6 (20%) developed grade III or IV Mucositis. Now, investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing myeloablative hematopoietic stem cell transplantation. The study drug and placebo will be supplied by CD Pharma India Private Limited.
Investigators further give undertaking that study will be carried as per GCP and declaration of Helsinki.
Detailed description
Study Design Placebo controlled double blind randomized, multi center clinical trial.
Study Population and Number of Subjects Total of 108 patients undergoing myeloablative allogeneic or autologous hematopoietic stem cell transplantation and receiving high-dose chemotherapy as conditioning regimen at AIIMS (departments of Medical Oncology and Hematology) will be enrolled for the study and will be equally divided in two groups (drug and placebo).
Study Center The study will be carried at Departments of Medical Oncology and Hematology of All India Institute of Medical Sciences, New Delhi, India.
More centers are likely to be added.
Study Objectives To test whether the probiotic Lactobacillus CD2 (drug) lozenges can reduce the incidence and severity of conditioning therapy induced oral mucositis in patients undergoing haematopoietic stem cell transplantation.
Investigational Product Drug: The trial medication is in the form of lozenge, which is supposed to be dissolved by itself in mouth.
It contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient.
Placebo: The placebo is a mix of sugars and salts used as excipients in the active formulation.
Note: Placebo and drug lozenges will be similar in physical appearance and color.
Dose of Study drug The daily dose of trial medications will be 4-6 lozenges per day, one lozenge to be taken every 2-3 hours preferably not before the meal. The lozenge should be kept in mouth for it to dissolve by itself. A hot beverage (e.g. tea, coffee, milk etc.) should not be taken for at least half an hour before and after the medication since elevated temperature can inactivate the bacteria.
Duration of treatment The treatment will start 4-7 days before starting chemotherapy for conditioning regime of HSCT and will continue till resolution of mucositis or Day+24 post stem cell infusion which-ever is earlier.
Efficacy Assessments
Clinical activity will be defined as reduction in the incidence and severity of chemotherapy induced mucositis in HSCT patients. Most recent version of CTCAE; clinical score of CTC V4.03 ( as also outlined in CTCAE version 3.0) will be used for mucositis assessment. Also,WHO and Oral Mucositis assessment score will be recorded. The study will have the following primary and secondary endpoints:
Primary endpoint
- Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups.
Secondary endpoint
- Determine the incidence of all Grade of mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation in two groups.
- Duration of and time period for healing of chemotherapy induced oral mucositis.
- Determine incidence and severity of dysphagia and requirement of IV antibiotics in two groups
Safety Assessments
- Medical History
- Physical Examination
- Vital Signs (blood pressure, pulse rate and respiratory rate)
- Laboratory Examinations
- Adverse Events
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus CD 2 lozenges | Active comparator | Drug: Lactobacillus CD 2, Other: Placebo2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient |
| Placebo lozenges | Placebo comparator | Drug: Lactobacillus CD 2, Other: PlaceboThe placebo is a mix of sugars and salts used as excipients in the active formulation |
Who may qualify
- Ages
- 10 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 10 and 70 years.
- Karnofsky Performance Score ≥ 70%.
- Confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is as approved modality of therapy.
- Patients eligible to receive high-dose chemotherapy as part of conditioning regime.
- Concomitant co morbid condition if present, controlled by medicines.
Key exclusion criteria (10 listed)
- Pregnant women and lactating mothers.
- Patients with history of AIDS
- Patients who have taken any other investigational product in last 4 weeks.
- Patients having untreated symptomatic dental infection.
- Patients with WHO Grade 3 or 4 oral Mucositis.
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 |
|---|---|---|
| Lactobacillus CD 22x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient | Drug | Lactobacillus CD 2 lozenges, Placebo lozenges |
| PlaceboThe placebo is a mix of sugars and salts used as excipients in the active formulation | Other | Lactobacillus CD 2 lozenges, Placebo lozenges |
Primary outcome
Incidence of mucositis grade(Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO)
Time frame: Day 0-Days 24
1. Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation in two groups
3 secondary outcomes
Incidence,duration and time period of mucositis Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO)
Time frame: Day 0-Days 24
Incidence,duration and time period of mucositis Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO)
Time frame: Day0- days 24
Incidence,duration and time period of mucositis Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO)
Time frame: day 0- days 24
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
- Results publication: PubMed 21741230Sharma A, Rath GK, Chaudhary SP, Thakar A, Mohanti BK, Bahadur S. Lactobacillus brevis CD2 lozenges reduce radiation- and chemotherapy-induced mucositis in patients with head and neck cancer: a randomized double-blind placebo-controlled study. Eur J Cancer. 2012 Apr;48(6):875-81. doi: 10.1016/j.ejca.2011.06.010. Epub 2011 Jul 6.
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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.
Atul Sharma, MD,DM principal investigator
All India Institute of Medical Sciences
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 Lactobacillus CD 2 in people with Oral Mucositis in Patients Undergoing HSCT, run by All India Institute of Medical Sciences at 1 site in India.
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 9 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: withdrawn, as of the sponsor's last update on 9 Nov 2016. 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 India. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of mucositis grade(Common Terminology Criteria of Adverse Events (CTCAE) and World health Organization (WHO) (time frame: Day 0-Days 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01797952, which also lists 1 linked publication.
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 9 Nov 2016.