NCT00197873

Brief Summary

Chemotherapy may cause diarrhoea, which may be associated with treatment delay and infections. The purpose of the study is to investigate whether oral supplementation with lactobacilli will alleviate chemotherapy related diarrhoea. Patients diagnosed with advanced colorectal cancer and who will receive chemotherapy will be randomly assigned to receive either lactobacilli or placebo during chemotherapy. The study is a prospective, multicenter, randomized, double-blind, placebo-controlled study. The primary outcome measure is frequency of moderate/severe diarrhoea. The study will also address safety and tolerability of chemotherapy, response to chemotherapy, and serum growth factor levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

November 24, 2021

Status Verified

November 1, 2021

Enrollment Period

15.3 years

First QC Date

September 12, 2005

Last Update Submit

November 22, 2021

Conditions

Colorectal Cancer

Keywords

colorectal cancerprobioticschemotherapypreventionadverse effectsdiarrhoea

Outcome Measures

Primary Outcomes (1)

  • Effect on the treatment-related grade 2 to 4 diarrhoea

    Numbers of bowel movements per day.

    18 weeks

Secondary Outcomes (3)

  • Effect on treatment related toxicity other than diarrhea

    18 weeks

  • Association between supplementation and response

    18 weeks

  • Effect on resectability of liver metastases

    1 year

Study Arms (2)

Lactophilus

ACTIVE COMPARATOR

Lactophilus supplementation

Dietary Supplement: Lactobacillus Rhamnosus supplementation

Placebo

PLACEBO COMPARATOR

Placebo is administered during chemotherapy.

Dietary Supplement: Lactobacillus Rhamnosus supplementationOther: Placebo administration.

Interventions

Lactobacillus Rhamnosus supplementationDIETARY_SUPPLEMENT

Lactophilus supplementation is administered during chemotherapy.

Also known as: Probiotics
LactophilusPlacebo
Placebo administration.OTHER

Placebo is administered during chemotherapy.

Also known as: Placebo.
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed diagnosis of CRC, chemotherapy naïve for metastatic disease (prior adjuvant chemotherapy for CRC allowed), who are scheduled to start capecitabine treatment as first line chemotherapy for metastatic disease
  • Age 18 or older
  • Measurable or non-measurable metastatic disease
  • Performance status ECOG performance status 0-2
  • Life expectancy greater than 3 months
  • Thrombocytes 100,000/µL or greater, neutrophils 1.500/µl or greater, Aspartate amino transferase/Alanine amino transferase \<= 2.5 x Upper limit of normal (ULN) (\< 5 x ULN if liver metastases present), Alkaline phosphatase \<=2.5 x ULN (\< 5 x ULN if liver metastases present), Serum bilirubin \<= 1.5 x ULN, Serum Creatinine \<= 1.5 x ULN, Urine dipstick of proteinuria \<2+ (or U-Prot \<100mg/dl). Patients discovered to have 2+ or greater proteinuria on dipstick urinalysis at baseline, must undergo a 24-hour urine collection and must have \<= 1 g of protein/24 hr
  • Women of childbearing potential must have a negative serum pregnancy test done prior to the administration of bevacizumab. Patient and their partner should prevent pregnancy (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile) up to at least 6 months after last treatment completion or the last drug dose, whatever happens first
  • Signed written informed consent according to ICH/GCP and the local regulations (approved by the Independent Ethics Committee \[IEC\]) will be obtained prior to any study specific screening procedures
  • Patient must be able to comply with the protocol

You may not qualify if:

  • Prior treatment with first-line chemotherapy for metastatic CRC
  • Adjuvant treatment with bevacizumab within 12 months
  • Acute or chronic diarrhea or colostomy
  • Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to Day 0 (Patients must have recovered from any major surgery)
  • Near future planned radiotherapy for underlying disease (prior completed radiotherapy treatment allowed)
  • Clinical or radiological evidence of CNS metastases
  • Past or current history within the last 5 years of malignancies except for the indication under this study and curatively treated Basal and squamous cell carcinoma of the skin or In-situ carcinoma of the cervix
  • Serious non-healing wound or ulcer
  • Evidence of bleeding diathesis or coagulopathy
  • Uncontrolled hypertension
  • Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication
  • Treatment with any investigational drug (including IMMP, EGFR inhibitors) or participation in another investigational study within 30 days prior to enrolment
  • Evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the treatment or patient at high risk from treatment complications
  • Ongoing treatment with aspirin (\> 325 mg/day), continuous high dose NSAIDS or other medications known to predispose to gastrointestinal ulceration
  • Pregnancy (positive serum pregnancy test) and lactation
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology

Helsinki, FIN-00029, Finland

Location

MeSH Terms

Conditions

Colorectal NeoplasmsDiarrhea

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Heikki Joensuu, M.D.

    Department of Oncology, Helsinki University Central Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2005

Primary Completion

November 30, 2020

Study Completion

December 31, 2020

Last Updated

November 24, 2021

Record last verified: 2021-11

Locations

FI(1)