A Pilot Study of Efficacy of Lactobacillus CD2 Lozenges in Preventing High-dose Chemotherapy Induced Oral Mucositis in Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT ID: NCT01480011

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2012-12-31

Brief 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%). 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.

Conditions

Oral Mucositis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

lactobacillus lozenges

The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient

Group Type: EXPERIMENTAL

lactobacillus CD2 lozenges

Intervention Type: DRUG

The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient

Interventions

lactobacillus CD2 lozenges

The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient

Intervention Type: DRUG

Other Intervention Names

CD#2

Eligibility Criteria

Inclusion Criteria

1. Age between 10 and 70 years.

2. Karnofsky Performance Score ≥ 70%.

3. Confirmed histological diagnosis of cancer/leukaemia for which haematopoietic stem cell transplantation is an approved modality of therapy.

4. Patients eligible to receive high-dose chemotherapy as part of conditioning regime.

5. Concomitant co morbid condition if present, controlled by medicines.

6. Serum creatinine 1.8mg/dl.

7. Total bilirubin 2mg/dl.

8. Liver enzymes within three times of normal limit.

9. Expected survival > 6 months.

Exclusion Criteria

1. Pregnant women and lactating mothers.

2. Patients with history of AIDS

3. Patients who have taken any other investigational product in last 4 weeks.

4. Patients having untreated symptomatic dental infection.

5. Patients with WHO Grade 3 or 4 oral Mucositis.

6. Other serious concurrent illness.

7. Inconclusive histological diagnosis.

8. Patients on anticancer antibiotics.

9. Patients with signs and symptoms of systemic infections.

10. Patient's/guardian's refusal to sign informed consent.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr Atul Sharma

Additional Professor Medical Oncology, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atul Sharma, MD,DM

Role: PRINCIPAL_INVESTIGATOR

Dr BRA Institute Rotary Cancer Hospital ,All India Institute of Medical Sciences,New Delhi ,India.

Locations

All India institute of Medical sciences

New Delhi, National Capital Territory of Delhi, India

Countries

India

References

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.

Reference Type: RESULT

PMID: 21741230 (View on PubMed)

Sharma 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.

Reference Type: DERIVED

PMID: 28848667 (View on PubMed)

Other Identifiers

P1101

Identifier Type: -

Identifier Source: org_study_id