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

NCT01480011 | Completed Phase 2

• 1 other identifier: P1101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

Lactobacillus CD2 lozenges; high-dose chemotherapy induced; hematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

• 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 .

  Day 24 of stem cell infusion or complete healing of mucositis

Secondary Outcomes (1)

• grade I and grade II mucositis

  Day 24 of stem cell infusion or complete healing of mucositis

Study Arms (1)

lactobacillus lozenges

EXPERIMENTAL

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

Drug: lactobacillus CD2 lozenges

Interventions

lactobacillus CD2 lozenges DRUG

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

Also known as: CD#2

lactobacillus lozenges

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Total bilirubin 2mg/dl.
• Liver enzymes within three times of normal limit.
• Expected survival \> 6 months.

You may not qualify if:

• 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.
• Inconclusive histological diagnosis.
• Patients on anticancer antibiotics.
• Patients with signs and symptoms of systemic infections.
• Patient's/guardian's refusal to sign informed consent.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India institute of Medical sciences

New Delhi, National Capital Territory of Delhi, 110029, India

Location

Related Publications (2)

• 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.

  PMID: 21741230 RESULT

• 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.

  PMID: 28848667 DERIVED

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Atul Sharma, MD,DM

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Additional Professor Medical Oncology, Principal Investigator

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: November 28, 2011
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

IN (1)