Oral MucositisPhase 2NCT01480011
A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation
A Phase 2 study testing lactobacillus CD2 lozenges in people with Oral Mucositis, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (between 95-100%). Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- lactobacillus CD2 lozenges
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2011to Dec 2012
- 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 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 an 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 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.
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- 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
All India institute of Medical sciences
New Delhi, National Capital Territory of Delhi, 110029
About this study
Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (between 95-100%). This mucositis not only causes significant morbidity but also hampers quality of life so much so that patients at times feel difficult to continue treatment.
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 the 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). No significant toxicity has been reported with its use.
Read more
Now, the investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be supplied by CD Pharma India Private Limited.
The investigators further give undertaking that study will be carried as per good clinical practices (GCP) and declaration of Helsinki.
- Conditions
- Oral Mucositis
- Being tested
- lactobacillus CD2 lozenges
- Keywords
- Lactobacillus CD2 lozenges, high-dose chemotherapy induced, 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 CD2 lozengesDrug
Also called CD#2
The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient
| Study group | Role | What they receive |
|---|---|---|
| lactobacillus lozenges | Experimental | The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient Receives: Drug: lactobacillus CD2 lozenges |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of grade III and grade IV mucositis
Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation .
Measured: Day 24 of stem cell infusion or complete healing of mucositis
Secondary outcomes (1)
grade I and grade II mucositis
- Determine the incidence of Grade I and II mucositis in patients undergoing allogenic or autologous haematopoietic stem cell transplantation.
- Duration of and time period for healing of chemotherapy induced oral mucositis.
- Determine incidence and severity of dysphagia
Measured: Day 24 of stem cell infusion or complete healing of mucositis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 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, Dr BRA Institute Rotary Cancer Hospital ,All India Institute of Medical Sciences,New Delhi ,India.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480011
- Sponsor's protocol ID
- P1101
- Status last verified
- Feb 2013
- First submitted
- 4 Nov 2011
- Last updated
- 20 Feb 2013
- 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 21741230Sharma A, Tilak T, Bakhshi S, Raina V, Kumar L, Chaudhary S, Sahoo R, Gupta R, Thulkar S. Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation. ESMO Open. 2017 Feb 13;1(6):e000138. doi: 10.1136/esmoopen-2016-000138. eCollection 2016.
PubMed 28848667
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01480011
- Acronym / sponsor ID
- P1101
- Conditions
- Oral Mucositis
- Keywords
- Lactobacillus CD2 lozenges, high-dose chemotherapy induced, hematopoietic stem cell transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Nov 2011 (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.
Patients with various malignancies who are taken up for high dose chemotherapy followed by stem cell transplant (blood and marrow transplant) have very high chances of developing severe oral mucositis (between 95-100%). This mucositis not only causes significant morbidity but also hampers quality of life so much so that patients at times feel difficult to continue treatment.
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 the 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). No significant toxicity has been reported with its use.
Now, the investigators want to study the efficacy of this drug to reduce severity of mucositis in patients undergoing hematopoietic stem cell transplantation. The drug will be supplied by CD Pharma India Private Limited.
The investigators further give undertaking that study will be carried as per good clinical practices (GCP) and declaration of Helsinki.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lactobacillus lozenges | Experimental | Drug: lactobacillus CD2 lozengesThe study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient |
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 an 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 CD2 lozengesAlso: CD#2The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient | Drug | lactobacillus lozenges |
Primary outcome
incidence of grade III and grade IV mucositis
Time frame: Day 24 of stem cell infusion or complete healing of mucositis
Determine the incidence of grade III and IV mucositis in patients undergoing allogeneic or autologous haematopoietic stem cell transplantation .
1 secondary outcome
grade I and grade II mucositis
Time frame: Day 24 of stem cell infusion or complete healing of mucositis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- 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.
- Derived from this study: PubMed 28848667Sharma A, Tilak T, Bakhshi S, Raina V, Kumar L, Chaudhary S, Sahoo R, Gupta R, Thulkar S. Lactobacillus brevis CD2 lozenges prevent oral mucositis in patients undergoing high dose chemotherapy followed by haematopoietic stem cell transplantation. ESMO Open. 2017 Feb 13;1(6):e000138. doi: 10.1136/esmoopen-2016-000138. eCollection 2016.
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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
Dr BRA Institute Rotary Cancer Hospital ,All India Institute of Medical Sciences,New Delhi ,India.
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 lactobacillus CD2 lozenges in people with Oral Mucositis, 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: finished, as of the sponsor's last update on 20 Feb 2013. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 grade III and grade IV mucositis (time frame: Day 24 of stem cell infusion or complete healing of mucositis). 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 NCT01480011, which also lists 2 linked publications.
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 20 Feb 2013.