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Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy SCC of the Anal Canal (BISQUIT) (BISQUIT)

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ClinicalTrials.gov Identifier: NCT03870607
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Rachel Riechelmann, AC Camargo Cancer Center

Brief Summary:
Phase II randomized study of the use of pre-and probiotics during the definitive treatment of chemotherapy-radiotherapy (Ch-RT) for patients with localized anal canal squamous cell cancer (ACSCC) with the objective of increasing the effectiveness of conventional treatment based on the assumptions of that there is a need for research that increases the cure rates of the definitive treatment of Ch-RT in the ACSCC; ACSCC is a virus-associated tumor in many cases and therefore potentially immunogenic; immunotherapy is a promising strategy in ACSCC; and that pre- and probiotics can stimulate the immune system through modulation of the intestinal microbiota, and improve oncological outcomes.

Condition or disease Intervention/treatment Phase
Anal Cancer Squamous Cell Dietary Supplement: prebiotics in combination with probiotics Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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;

  3. 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.

  4. Proportion of patients without colostomy [ Time Frame: Twelve months ]
    Proportion of patients without colostomy 12 months after Ch-RT termination.

  5. 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.

  6. 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

  7. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 18 years;
  • Confirmed histological diagnosis of squamous cell carcinoma / squamous cell carcinoma of the anal canal (ACSCC);
  • Patients with localized ACSCC (≥ T2N0M0, according to American Joint Committee on Cancer (AJCC) 8th edition) staged by conventional imaging methods according to institutional routine;
  • Indication of starting definitive treatment with Ch-RT in the institution. HIV-positive patients may be included;
  • Free and informed consent signed by the patient or legal representative

Exclusion Criteria:

  • Diagnosis of perianal squamous cell carcinomas;
  • Clinical condition leading to difficulty in swallowing;
  • Patients with a contraindication to receiving Ch-RT, ie receiving only radiotherapy or not receiving polychemotherapy;
  • Clinical condition that, due to the investigator's judgment, prevents adherence to the study
  • Active infection requiring antibiotic therapy

Information from the National Library of Medicine

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


Contacts
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Contact: Rachel SP Riechelmann, MD +55 (11) 2189-5000 ext 2779 rachel.riechelmann@accamargo.org.br
Contact: Mauro DS Donadio, MD +55 (11) 2189-5000 ext 2779 maurodsd@gmail.com

Locations
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Brazil
AC Camargo Cancer Center Recruiting
São Paulo, SP, Brazil, 01525000
Contact: Rachel SP Riechelmann, Phd    +5511 21895000 ext 2779    rachelri2005@gmail.com   
Contact: Mauro DS Donadio, Dr    +5511 21895000 ext 2779    maurodsd@gmail.com   
Sponsors and Collaborators
AC Camargo Cancer Center
Investigators
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Principal Investigator: Rachel SP Riechelmann, MD AC Camargo Cancer Center
  Study Documents (Full-Text)

Documents provided by Rachel Riechelmann, AC Camargo Cancer Center:

Publications of Results:

Other Publications:
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Responsible Party: Rachel Riechelmann, Head of Departament of Clinical Oncology, AC Camargo Cancer Center
ClinicalTrials.gov Identifier: NCT03870607     History of Changes
Other Study ID Numbers: 2625-18
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rachel Riechelmann, AC Camargo Cancer Center:
probiotics
prebiotics
microbiome

Additional relevant MeSH terms:
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Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases