Cognitive/Functional EffectsPhase 3NCT01473290
Probiotic Therapy in Preventing Gastrointestinal Complications in Patients Undergoing Chemotherapy and Pelvic Radiation Therapy
A Phase 3 study testing live freeze-dried lactic acid bacteria probiotic in people with Cognitive/Functional Effects and Constipation, Impaction, and Bowel Obstruction, run by Alliance for Clinical Trials in Oncology.
Trial summary
RATIONALE: Probiotic therapy may reduce or prevent gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy. PURPOSE: This randomized phase III trial is studying how well probiotic therapy works in preventing gastrointestinal complications in patients undergoing chemotherapy and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive/Functional Effects, Constipation, Impaction, and Bowel Obstruction, Diarrhea
- What is being tested?
- live freeze-dried lactic acid bacteria probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Current diagnosis of cancer that supports the use of continuous definitive or adjuvant external-beam radiotherapy (RT) to the pelvis to a minimum dose of 4,500 cGy with the following parameters:
- The pelvis must be encompassed by the planned RT fields
- The superior border may not lie inferior to the most inferior aspect of the sacroiliac joints
- Portions of the rectum may have special blocking, depending upon disease site
- The total prescription dose must lie between 4,500-5,350 cGy (inclusive)
- A boost to primary tumor or tumor bed may be planned
- Planned treatment is to be given 4-5 times per week on a one- treatment-per-day basis
- The daily prescribed dose must lie between 170-210 cGy (inclusive) per day
- No planned split-course RT
- No proton RT
- Will receive concurrent administration of chemotherapy (fluorouracil, capecitabine, cisplatin, oxaliplatin, carboplatin, and/or mitomycin C) during pelvic RT
- No current or prior metastases beyond regional lymph nodes
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) of 0, 1, or 2
- Life expectancy ≥ 6 months
- Able to complete questionnaire(s) by themselves or with assistance
- Not pregnant or nursing
- Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only
- Fertile patients must use effective contraception
- Hemoglobin > 10.0 g/dL
- White blood cells (WBC) > 3,500/mm³
- Absolute neutrophil count (ANC) > 1,500/mm³
- Platelet count > 100,000/mm³
- Willing to abstain from ingestion of yogurt products and/or any product containing probiotics during study drug treatment
- No known allergy to a probiotic preparation
- No history of inflammatory bowel disease
- No ≥ grade 3 diarrhea, ≥ grade 3 rectal bleeding, abdominal cramping, or incontinence of stool ≤ 7 days prior to registration
- No medical condition that may interfere with ability to receive protocol treatment
- No history of gastrointestinal or genitourinary obstruction or porphyria
- No history of irritable bowel syndrome (IBS)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior abdominal-perineal resection, Hartmann procedure, or other surgical procedure leaving the patient without a functioning rectum
- No planned use of leucovorin
- No prior pelvic RT
- No use of probiotics ≤ 2 weeks prior to registration
- No use of antibiotics ≤ 3 days prior to registration
- No planned continuous antibiotic treatment during RT
About this study
Official title: A Phase III, Randomized, Double-Blind Placebo Controlled Study of the Probiotic Preparation VSL#3® Versus Placebo in the Prevention of Acute Enteritis in Patients Receiving Concurrent Chemotherapy and Pelvic Radiation Therapy
RATIONALE: Probiotic therapy may reduce or prevent gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy.
PURPOSE: This randomized phase III trial is studying how well probiotic therapy works in preventing gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy.
Read the detailed description
OBJECTIVES:
Primary
- To determine whether live freeze-dried lactic acid bacteria probiotic (VSL#3®) is effective in reducing the acute treatment-related bowel function disturbances, as measured by the FACIT-D diarrhea subscale score in patients receiving concurrent chemotherapy and pelvic RT as adjuvant or primary treatment for malignancy.
Secondary
- To determine whether VSL#3® can reduce chronic treatment-related bowel dysfunction following completion of therapy.
- To examine whether VSL#3® appears to have an impact on disease-free survival.
- To bank blood products for future studies. (exploratory)
- To characterize changes in the fecal microbiota and examine for correlation with treatment assignment and symptom scores. (exploratory)
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to site of primary tumor (rectum/anus vs other), history of anterior resection of the rectum (yes vs no), total planned cumulative dose (including boost of external-beam radiotherapy [RT] or brachytherapy) (4,500-5,350 cGy vs > 5,350 cGy), and use of intensity-modulated RT [IMRT] for pelvic RT (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive live freeze-dried lactic acid bacteria probiotic (VSL#3®) orally (PO) 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
- Arm II: Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
Patients self-report symptoms using the FACIT-D, PBFQ, PRO-CTCAE, and Uniscale/fatigue weekly during RT, for 2 weeks after completion of RT, and at 12 months following the completion of RT.
Blood and stool samples may be collected from some patients for correlative studies.
- Conditions
- Cognitive/Functional Effects, Constipation, Impaction, and Bowel Obstruction, Diarrhea, Fatigue, Gastrointestinal Complications, Psychosocial Effects of Cancer and Its Treatment
- Being tested
- live freeze-dried lactic acid bacteria probiotic, placebo
- Keywords
- diarrhea, constipation, impaction, and bowel obstruction, gastrointestinal complications, fatigue, psychosocial effects of cancer and its treatment, cognitive/functional effects, unspecified adult solid tumor, protocol specific
- Medical subject headings
- Constipation, Intestinal Obstruction, Diarrhea, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
live freeze-dried lactic acid bacteria probioticDietary supplement
Given orally (PO)
placeboOther
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive live freeze-dried lactic acid bacteria probiotic (VSL#3®) orally (PO) 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT. Receives: Dietary Supplement: live freeze-dried lactic acid bacteria probiotic |
| Arm II | Placebo comparator | Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average area under the curve (AUC) of the FACIT-D diarrhea subscale score assessed weekly during treatment and for two weeks following the completion of RT
Measured: Up to 12 months
Secondary outcomes (3)
Bowel function measures as assessed by the clinician using the CTCAE version 4 and as assessed by the PBFQ and the PRO-CTCAE
Measured: Up to 12 months
Psychometric evaluation of the reliability and validity of the FACIT-D diarrhea subscale, PBFQ, and PRO-CTCAE
Measured: Up to 12 months
Disease-free survival
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
Why it stopped: The study was not activated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive/Functional EffectsStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Robert C. Miller, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473290
- Sponsor's protocol ID
- NCCTG-N10CB
- Other IDs
- NCI-2011-03636, CDR0000716291
- Status last verified
- Jul 2016
- First submitted
- 15 Nov 2011
- Last updated
- 6 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind Placebo Controlled Study of the Probiotic Preparation VSL#3® Versus Placebo in the Prevention of Acute Enteritis in Patients Receiving Concurrent Chemotherapy and Pelvic Radiation Therapy
- ClinicalTrials.gov ID
- NCT01473290
- Acronym / sponsor ID
- NCCTG-N10CB
- Conditions
- Cognitive/Functional Effects, Constipation, Impaction, and Bowel Obstruction, Diarrhea, Fatigue, Gastrointestinal Complications, Psychosocial Effects of Cancer and Its Treatment
- Keywords
- diarrhea, constipation, impaction, and bowel obstruction, gastrointestinal complications, fatigue, psychosocial effects of cancer and its treatment, cognitive/functional effects, unspecified adult solid tumor, protocol specific
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not activated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- First posted
- 17 Nov 2011 (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.
RATIONALE: Probiotic therapy may reduce or prevent gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy.
PURPOSE: This randomized phase III trial is studying how well probiotic therapy works in preventing gastrointestinal complications in patients undergoing chemotherapy and pelvic radiation therapy.
Detailed description
OBJECTIVES:
Primary
- To determine whether live freeze-dried lactic acid bacteria probiotic (VSL#3®) is effective in reducing the acute treatment-related bowel function disturbances, as measured by the FACIT-D diarrhea subscale score in patients receiving concurrent chemotherapy and pelvic RT as adjuvant or primary treatment for malignancy.
Secondary
- To determine whether VSL#3® can reduce chronic treatment-related bowel dysfunction following completion of therapy.
- To examine whether VSL#3® appears to have an impact on disease-free survival.
- To bank blood products for future studies. (exploratory)
- To characterize changes in the fecal microbiota and examine for correlation with treatment assignment and symptom scores. (exploratory)
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to site of primary tumor (rectum/anus vs other), history of anterior resection of the rectum (yes vs no), total planned cumulative dose (including boost of external-beam radiotherapy [RT] or brachytherapy) (4,500-5,350 cGy vs > 5,350 cGy), and use of intensity-modulated RT [IMRT] for pelvic RT (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive live freeze-dried lactic acid bacteria probiotic (VSL#3®) orally (PO) 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
- Arm II: Patients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT.
Patients self-report symptoms using the FACIT-D, PBFQ, PRO-CTCAE, and Uniscale/fatigue weekly during RT, for 2 weeks after completion of RT, and at 12 months following the completion of RT.
Blood and stool samples may be collected from some patients for correlative studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Dietary Supplement: live freeze-dried lactic acid bacteria probioticPatients receive live freeze-dried lactic acid bacteria probiotic (VSL#3®) orally (PO) 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT. |
| Arm II | Placebo comparator | Other: placeboPatients receive placebo PO 3 times a day during RT (5-8 weeks) and for 2 weeks after completion of RT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| live freeze-dried lactic acid bacteria probioticGiven orally (PO) | Dietary supplement | Arm I |
| placeboGiven PO | Other | Arm II |
Primary outcome
Average area under the curve (AUC) of the FACIT-D diarrhea subscale score assessed weekly during treatment and for two weeks following the completion of RT
Time frame: Up to 12 months
3 secondary outcomes
Bowel function measures as assessed by the clinician using the CTCAE version 4 and as assessed by the PBFQ and the PRO-CTCAE
Time frame: Up to 12 months
Psychometric evaluation of the reliability and validity of the FACIT-D diarrhea subscale, PBFQ, and PRO-CTCAE
Time frame: Up to 12 months
Disease-free survival
Time frame: Up to 12 months
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 6 Jul 2016.
Related trials for Cognitive/Functional Effects
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Not yet recruiting
The Effects of Ischemic Conditioning in Individuals With Parkinson's Disease
Parkinson Disease
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Active, not recruiting
Effects of Individualized Preferred and Higher Treadmill Walking Speeds Followed by Cognitive Training on Heart Rate Variability, Gait Performance, and Motor-Cognitive Function in Older Adults With Type 2 Diabetes: A Randomized Controlled Trial With 4-Week Retention Follow-up
Diabetes Mellitus, Type 2
Enrolling by invitation
Effect of Hand Rehabilitation on Cognitive Function in Patients With PD
PARKINSON DISEASE (Disorder)
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.
Robert C. Miller, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing live freeze-dried lactic acid bacteria probiotic in people with Cognitive/Functional Effects and Constipation, Impaction, and Bowel Obstruction, run by Alliance for Clinical Trials in Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Average area under the curve (AUC) of the FACIT-D diarrhea subscale score assessed weekly during treatment and for two weeks following the completion of RT (time frame: Up to 12 months). 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 6 Jul 2016.