DiarrheaPhase 2NCT01644097
Probiotic Supplementation in Preventing Treatment-Related Diarrhea in Patients With Cancer Undergoing Chemotherapy
A Phase 2 study testing Lactobacillus plantarum strain 299v, Lactobacillus acidophilus probiotic and laboratory biomarker analysis in people with Diarrhea and Unspecified Adult Solid Tumor, Protocol Specific, run by Stanford University at 1 site in United States.
Trial summary
This randomized phase II clinical trial studies probiotic supplementation in preventing treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may help prevent diarrhea caused by treatment with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- Lactobacillus plantarum strain 299v, Lactobacillus acidophilus probiotic and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Sep 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient with a documented malignancy initiating treatment including (as a single agent or in combination with other drugs) any one of the following cancer therapeutics:
- o Fluorouracil (5FU), capecitabine, irinotecan, paclitaxel, docetaxel, cabazitaxel, crizotinib, sorafenib, sunitinib, erlotinib, or lapatinib
- Any pathologically confirmed malignancy for which the patient would receive any of the listed cancer therapeutics
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
- Patient must have an estimated life expectancy of at least 6 months
- Absolute neutrophil count (ANC) > 1500
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- Platelets > 100K
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x ULN (upper limit normal)
- Serum bilirubin < 1.5 x ULN
- Serum creatinine < 1.5 x ULN
- Ability to understand and the willingness to sign a written informed consent document and comply with the treatment protocol
Who cannot join
- Patients currently undergoing treatment with the above listed therapeutics at time of initiation of trial; patients can have had prior treatment(s) with one or more of the agents if they are initiating a new treatment with another agent on the list, provided they have had at least a 2 week "washout" period
- Patients currently taking anti-diarrheal medications or therapy
- Patients undergoing hemodialysis
- Patients with known allergic or hypersensitivity reaction to probiotics, yoghurt, or similar diet or supplemental products
- Acute or chronic diarrhea, including lactose intolerance, gluten or other dietary sensitivity resulting in gastrointestinal symptoms
- Pregnant or nursing patients
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- Known human immunodeficiency virus (HIV) positive
- Prior abdominal surgery resulting in a stoma, ostomy, fistula, or other anatomic defect
- Concurrent or near future radiotherapy; prior, completed radiotherapy allowed; any radiotherapy within the vicinity of the GI tract must have been completed at least 4 weeks prior to start of trial
- Treatment with any investigational drug within 4 weeks prior to enrollment
- Current treatment with antibiotics or other gut motility agents within 2 weeks of starting study medication
- Abnormal thyroid function that is not controlled with medication
- Patients taking other dietary supplements within 2 weeks of starting study medication
- Any other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Feasibility and Correlative Study of Probiotic Supplementation in Cancer Patients Receiving Chemotherapy or Tyrosine Kinase Inhibitors (TKIs)
This randomized phase II clinical trial studies probiotic supplementation in preventing treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may help prevent diarrhea caused by treatment with chemotherapy.
Read the detailed description
PRIMARY OBJECTIVES:
- Incidence of moderate/severe (grade 2-4) diarrhea graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
II. Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Trial Outcome Index.
SECONDARY OBJECTIVES:
- To evaluate the effects of probiotic supplementation on dose delays or reductions due to gastrointestinal (GI) toxicity.
II. To evaluate the effects of probiotic supplementation on anti-diarrheal medication use.
III. To evaluate the effects of probiotic supplementation on overall health-related quality of life (HR-QOL).
IV. To evaluate the effects of probiotic supplementation on febrile neutropenia.
- To evaluate the effects of probiotic supplementation on adverse GI effects. VI. To evaluate the effects of probiotic supplementation on overall survival. VII. To evaluate the effects of probiotic supplementation on progression free survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a mixture of Lactobacillus plantarum strain 299v, Bifidobacterium lactis probiotic supplement, and Lactobacillus acidophilus probiotic orally (PO) twice daily (BID) for 9 weeks. Treatment continues in the absence of unacceptable toxicity.
ARM II: Patients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.
- Being tested
- Lactobacillus plantarum strain 299v, Lactobacillus acidophilus probiotic, placebo, laboratory biomarker analysis, questionnaire administration
- Keywords
- Quality of Life
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus plantarum strain 299vDietary supplement
Also called DSM 9843, Lp 299v
Given PO
Lactobacillus acidophilus probioticDietary supplement
Given PO
placeboDietary supplement
Also called PLCB
Given PO
laboratory biomarker analysisOther
Correlative studies
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
Bifidobacterium lactis probiotic supplementDietary supplement
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (probiotic mix) | Experimental | Patients receive a mixture of Lactobacillus plantarum strain 299v, Bifidobacterium lactis probiotic supplement, and Lactobacillus acidophilus probiotic PO BID for 9 weeks. Treatment continues in the absence of unacceptable toxicity. Receives: Dietary Supplement: Lactobacillus plantarum strain 299v; Dietary Supplement: Lactobacillus acidophilus probiotic; Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: quality-of-life assessment; Dietary Supplement: Bifidobacterium lactis probiotic supplement |
| Arm II (placebo) | Placebo comparator | Patients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity. Receives: Dietary Supplement: placebo; Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0
Will be calculated by the percentage of patients experiencing grade 2-4 diarrhea as documented by patient diary and primary oncologist's documentation. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.
Measured: Up to 9 weeks
FACIT-D Trial Outcome Index (TOI)
The FACIT-D TOI has a range of scores from 0-100 which are a combination of physical well being, functional well being, and diarrhea subscale. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.
Measured: Up to 4 weeks post treatment
Secondary outcomes (7)
Dose delays or reductions due to GI toxicity
Measured: Up to 9 weeks
Anti-diarrheal use
Measured: Up to 9 weeks
Overall HR-QOL
Measured: Up to 4 weeks post treatment
Febrile neutropenia
Measured: Up to 4 weeks post treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Up to 4 weeks post treatment
Overall survival
Measured: Up to 2 years
Progression free survival
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startNov 2012
- Primary completionSep 2014 (estimated)
Why it stopped: issues with obtaining study product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Russell Pachynski, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644097
- Sponsor's protocol ID
- VAR0084
- Other IDs
- NCI-2012-01127
- Status last verified
- Feb 2014
- First submitted
- 12 Jul 2012
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Feasibility and Correlative Study of Probiotic Supplementation in Cancer Patients Receiving Chemotherapy or Tyrosine Kinase Inhibitors (TKIs)
- ClinicalTrials.gov ID
- NCT01644097
- Acronym / sponsor ID
- VAR0084
- Keywords
- Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: issues with obtaining study product
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2012
- Primary completion
- Sep 2014 (estimated)
- First posted
- 18 Jul 2012 (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.
This randomized phase II clinical trial studies probiotic supplementation in preventing treatment-related diarrhea in patients with cancer undergoing chemotherapy. Probiotics may help prevent diarrhea caused by treatment with chemotherapy.
Detailed description
PRIMARY OBJECTIVES:
- Incidence of moderate/severe (grade 2-4) diarrhea graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
II. Functional Assessment of Chronic Illness Therapy - Diarrhea (FACIT-D) Trial Outcome Index.
SECONDARY OBJECTIVES:
- To evaluate the effects of probiotic supplementation on dose delays or reductions due to gastrointestinal (GI) toxicity.
II. To evaluate the effects of probiotic supplementation on anti-diarrheal medication use.
III. To evaluate the effects of probiotic supplementation on overall health-related quality of life (HR-QOL).
IV. To evaluate the effects of probiotic supplementation on febrile neutropenia.
- To evaluate the effects of probiotic supplementation on adverse GI effects. VI. To evaluate the effects of probiotic supplementation on overall survival. VII. To evaluate the effects of probiotic supplementation on progression free survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive a mixture of Lactobacillus plantarum strain 299v, Bifidobacterium lactis probiotic supplement, and Lactobacillus acidophilus probiotic orally (PO) twice daily (BID) for 9 weeks. Treatment continues in the absence of unacceptable toxicity.
ARM II: Patients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity.
After completion of study treatment, patients are followed up at 4 weeks and then every 3 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (probiotic mix) | Experimental | Dietary Supplement: Lactobacillus plantarum strain 299v, Dietary Supplement: Lactobacillus acidophilus probiotic, Other: laboratory biomarker analysis, Other: questionnaire administration, Procedure: quality-of-life assessment, Dietary Supplement: Bifidobacterium lactis probiotic supplementPatients receive a mixture of Lactobacillus plantarum strain 299v, Bifidobacterium lactis probiotic supplement, and Lactobacillus acidophilus probiotic PO BID for 9 weeks. Treatment continues in the absence of unacceptable toxicity. |
| Arm II (placebo) | Placebo comparator | Dietary Supplement: placebo, Other: laboratory biomarker analysis, Other: questionnaire administration, Procedure: quality-of-life assessmentPatients receive placebo PO BID 9 weeks. Treatment continues in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Any patient with a documented malignancy initiating treatment including (as a single agent or in combination with other drugs) any one of the following cancer therapeutics:
- o Fluorouracil (5FU), capecitabine, irinotecan, paclitaxel, docetaxel, cabazitaxel, crizotinib, sorafenib, sunitinib, erlotinib, or lapatinib
- Any pathologically confirmed malignancy for which the patient would receive any of the listed cancer therapeutics
- Performance status of Eastern Cooperative Oncology Group (ECOG) 0-2
- Patient must have an estimated life expectancy of at least 6 months
Key exclusion criteria (14 listed)
- Patients currently undergoing treatment with the above listed therapeutics at time of initiation of trial; patients can have had prior treatment(s) with one or more of the agents if they are initiating a new treatment with another agent on the list, provided they have had at least a 2 week "washout" period
- Patients currently taking anti-diarrheal medications or therapy
- Patients undergoing hemodialysis
- Patients with known allergic or hypersensitivity reaction to probiotics, yoghurt, or similar diet or supplemental products
- Acute or chronic diarrhea, including lactose intolerance, gluten or other dietary sensitivity resulting in gastrointestinal symptoms
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 plantarum strain 299vAlso: DSM 9843, Lp 299vGiven PO | Dietary supplement | Arm I (probiotic mix) |
| Lactobacillus acidophilus probioticGiven PO | Dietary supplement | Arm I (probiotic mix) |
| placeboAlso: PLCBGiven PO | Dietary supplement | Arm II (placebo) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (probiotic mix), Arm II (placebo) |
| questionnaire administrationAncillary studies | Other | Arm I (probiotic mix), Arm II (placebo) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (probiotic mix), Arm II (placebo) |
| Bifidobacterium lactis probiotic supplementGiven PO | Dietary supplement | Arm I (probiotic mix) |
Primary outcome
Incidence of grade 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0
Time frame: Up to 9 weeks
Will be calculated by the percentage of patients experiencing grade 2-4 diarrhea as documented by patient diary and primary oncologist's documentation. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.
FACIT-D Trial Outcome Index (TOI)
Time frame: Up to 4 weeks post treatment
The FACIT-D TOI has a range of scores from 0-100 which are a combination of physical well being, functional well being, and diarrhea subscale. The data for patients on tyrosine kinase inhibitors and conventional cytotoxic chemotherapy will be analyzed both combined and separately.
7 secondary outcomes
Dose delays or reductions due to GI toxicity
Time frame: Up to 9 weeks
Anti-diarrheal use
Time frame: Up to 9 weeks
Overall HR-QOL
Time frame: Up to 4 weeks post treatment
Febrile neutropenia
Time frame: Up to 4 weeks post treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 4 weeks post treatment
Overall survival
Time frame: Up to 2 years
Progression free survival
Time frame: Up to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
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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.
Russell Pachynski principal investigator
Stanford University
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 plantarum strain 299v, Lactobacillus acidophilus probiotic and laboratory biomarker analysis in people with Diarrhea and Unspecified Adult Solid Tumor, Protocol Specific, run by Stanford University at 1 site in United States.
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 11 inclusion and 14 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: withdrawn, as of the sponsor's last update on 14 Feb 2014. 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 United States. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 2-4 diarrhea over the 9-week study period, assessed by CTCAE version 4.0 (time frame: Up to 9 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2014.