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Proffered paper session - Supportive and palliative care

2767 - Final results of a phase II/III, randomized, double blind, placebo-controlled study to investigate the efficacy of a high potency multistrain probiotic, on chemotherapy induced diarrhea in cancer patients receiving fluropyrimidines and/or irinotecan based therapy

Date

21 Oct 2018

Session

Proffered paper session - Supportive and palliative care

Topics

Cytotoxic Therapy;  Supportive Care and Symptom Management

Tumour Site

Presenters

Atul Sharma

Authors

A. Sharma1, S.P. Chaudhary1, V. Raina1, N.K. Shukla2, V. Sreenivas3, S. Prakash4, P. Priyatma4, S. Bharti4

Author affiliations

  • 1 Medical Oncology, B.R. Ambedkar Institute Rotary Cancer Hospital (AIMS), 110029 - New Delhi/IN
  • 2 Surgical oncology, B.R. Ambedkar Institute Rotary Cancer Hospital (AIMS), 110029 - New Delhi/IN
  • 3 Biostatistics, All India Institute of Medical Sciences, 110029 - New Delhi/IN
  • 4 Lab Medicine, All India Institute of Medical Sciences, 110029 - New Delhi/IN
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Abstract 2767

Background

Chemotherapy-induced diarrhea (CID) is a common side-effect, associated with weight-loss, malnutrition, and treatment breaks. Chemotherapy changes the composition of the native gut microflora. We hypothesized that a high-concentration multi-strain probiotic product might improve the balance of intestinal flora and thus reduce the incidence of severe diarrheal grades.

Methods

Randomized, double-blind, placebo-controlled single center study. Total sample size calculated was 242, however, protocol was amended to enrol 291 patients, accounting for loss to follow up or protocol deviations. Primary end-point was incidence of grade 3 and grade 4 diarrhea. Analysis of serum VEGF & clusterin and fecal calprotectin was also planned. Regulatory approvals and trial registration were done before study initiation.

Enrolled patients were randomized to receive 1 sachet bid of study drug (900 billion CFU/sachet of 4 strains of Lactobacillus, 3 strains of Bifidobacteria and 1 strain of Streptococcus thermophilus) or placebo (corn starch), starting 14 days before chemotherapy and continued till two weeks after end of chemotherapy cycle 3.

Results

Between July 2010 to November 2014, 291 patients were enrolled at AIIMS, New Delhi. Type and site of cancer (p=0.882) and chemotherapy regimen (p=0.492) were similar in both groups. Body weight between the two arms was found to be comparable at all study visits. Results are shown in Table-1.

Table -1

Variables

Drug

Placebo

P value

DEMOGRAPHY

Total (N)

145

146

NS

Male [N(%)]

113 (77.9)

123 (84.2)

0.160*

Age in years (Mean ± SD)

46.4 ± 11.8

45.6 ± 12.1

0.615^

ENDPOINTS ASSESSMENTS

Incidence of all diarrheal grades (N)

199

220

0.019*

Grade III [N(%)]

16 (8.0)

9 (4.1)

0.088*

Grade IV [N(%)]

4 (2)

0 (0)

0.050#

Rescue medication [N(%)]

15 (5.5)

20 (6.2)

0.440*

INFLAMMATORY AND OTHER MARKERS ASSESSMENTS@ at study end

VEGF

829.5 ± 345.0

1416.91 ± 379.9

< 0.001**

Calprotectin

485.1 ± 117.2

617.40 ± 140.1

< 0.001**

Clusterin

102.4 ± 38.0

145.86 ± 31.5

< 0.001**

* Pearson chi-square test

^ T-test

# Fisher’s Exact test

** Mann-Whitney Test

@ Comparable at baseline

Conclusions

Results indicate a limited role of the probiotic in reducing incidence of severe CID. However, it was able to significantly reduce all grades of diarrheal episodes (taken together), levels of VEGF, fecal calprotectin and clusterin.

Clinical trial identification

Clinical Trial Registry India Identifier : CTRI/2009/091/001042

Editorial Acknowledgement

Not Applicable

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