Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy SCC of the Anal Canal (BISQUIT) (BISQUIT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03870607|
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : March 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anal Cancer Squamous Cell||Dietary Supplement: prebiotics in combination with probiotics||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible patients who consent to participate in this study will be randomized 1: 1 in two groups: Group A or experimental and Group B or control|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The researchers will identify the patients through a unique number and through the initials of the name. Randomization will be simple and conducted independently by clinical trial support staff who are not participating in the study. The random sequence will be generated by computer program.|
|Official Title:||A Randomized Phase II Study of the Administration of Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy for Patients With Squamous Cell Carcinoma of the Anal Canal (BISQUIT)|
|Actual Study Start Date :||March 13, 2019|
|Estimated Primary Completion Date :||August 13, 2022|
|Estimated Study Completion Date :||February 11, 2024|
Experimental: Prebiotics and probiotics group
This group will receive standard nutritional guidance from the institutional routine and prebiotics in combination with probiotics, starting one week before the start of Ch-RT and daily throughout the treatment up to 6 to 8 weeks post Ch-RT at the time of evaluation response (primary outcome).
Dietary Supplement: prebiotics in combination with probiotics
Administration of prebiotics in combination with probiotics before the start of Ch-RT
Other Name: Symbioflor
No Intervention: Control group
This group will lead nutritionally based just before starting Ch-RT.
- Response rate (clinical and radiological) [ Time Frame: Six to eight weeks from the end of Ch-RT ]absence of visible disease at the clinical examination and magnetic resonance imaging (MRI) of the pelvis (or pelvic tomography, if contraindicated to MRI) and without disease at a distance, through tomography of the chest and abdomen.
- Metabolic response by 18-FDG PET-CT [ Time Frame: Six to eight weeks from the end of Ch-RT ]Comparing the mean pre-and post-Ch-RT volume-capture measurements of each patient at 6-8 weeks post Ch-RT
- Complete clinical and radiological response rate [ Time Frame: Six months ]defined as absence of disease visible to clinical and pelvic MRI (or pelvic tomography) exams and without disease at a distance, through tomography of the chest and abdomen;
- Progression / disease free survival [ Time Frame: through study completion, an average of 5 years ]defined as the time from day1 cycle 1 of Ch-RT treatment to local or remote relapse, or death from any cause, whichever occurs first.
- Proportion of patients without colostomy [ Time Frame: Twelve months ]Proportion of patients without colostomy 12 months after Ch-RT termination.
- Incidence of Adverse Events Treatment-related [ Time Frame: through study completion, an average of 5 years ]Adverse events of grade 2 or higher by the Common Adverse Event Toxicity Criteria (CTCAE) version 4.0.
- Incidence of HPV in tumor tissue [ Time Frame: through study completion, an average of 3 years ]Incidence of positivity for HPV screening in tumor tissue through genotyping
- Variation of systemic immune parameters [ Time Frame: through study completion, an average of 3 years ]Defined by variation in total number of lymphocytes, neutrophil / lymphocyte ratio (NLR) and lymphocyte / monocyte ratio (LMR)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870607
|Contact: Rachel SP Riechelmann, MD||+55 (11) 2189-5000 ext firstname.lastname@example.org|
|Contact: Mauro DS Donadio, MD||+55 (11) 2189-5000 ext email@example.com|
|AC Camargo Cancer Center||Recruiting|
|São Paulo, SP, Brazil, 01525000|
|Contact: Rachel SP Riechelmann, Phd +5511 21895000 ext 2779 firstname.lastname@example.org|
|Contact: Mauro DS Donadio, Dr +5511 21895000 ext 2779 email@example.com|
|Principal Investigator:||Rachel SP Riechelmann, MD||AC Camargo Cancer Center|