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

NCT03870607 | Unknown Phase 2

• 1 other identifier: 2625-18
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Anal Cancer Squamous Cell

Keywords

probiotics; prebiotics; microbiome

Outcome Measures

Primary Outcomes (1)

• Response rate (clinical and radiological)

  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.

  Six to eight weeks from the end of Ch-RT

Secondary Outcomes (7)

• Metabolic response by 18-FDG PET-CT

  Six to eight weeks from the end of Ch-RT

• Complete clinical and radiological response rate

  Six months

• Progression / disease free survival

  through study completion, an average of 5 years

• Proportion of patients without colostomy

  Twelve months

• Incidence of Adverse Events Treatment-related

  through study completion, an average of 5 years

Study Arms (2)

Prebiotics and probiotics group

EXPERIMENTAL

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

Control group

NO INTERVENTION

This group will lead nutritionally based just before starting Ch-RT.

Interventions

prebiotics in combination with probiotics DIETARY_SUPPLEMENT

Administration of prebiotics in combination with probiotics before the start of Ch-RT

Also known as: Symbioflor

Prebiotics and probiotics group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

AC Camargo Cancer Center

São Paulo, São Paulo, 01525000, Brazil

RECRUITING

Related Publications (11)

• Niederreiter L, Adolph TE, Tilg H. Food, microbiome and colorectal cancer. Dig Liver Dis. 2018 Jul;50(7):647-652. doi: 10.1016/j.dld.2018.03.030. Epub 2018 Apr 3.

  PMID: 29705028 BACKGROUND

• Scott TA, Quintaneiro LM, Norvaisas P, Lui PP, Wilson MP, Leung KY, Herrera-Dominguez L, Sudiwala S, Pessia A, Clayton PT, Bryson K, Velagapudi V, Mills PB, Typas A, Greene NDE, Cabreiro F. Host-Microbe Co-metabolism Dictates Cancer Drug Efficacy in C. elegans. Cell. 2017 Apr 20;169(3):442-456.e18. doi: 10.1016/j.cell.2017.03.040.

  PMID: 28431245 BACKGROUND

• Alexander JL, Wilson ID, Teare J, Marchesi JR, Nicholson JK, Kinross JM. Gut microbiota modulation of chemotherapy efficacy and toxicity. Nat Rev Gastroenterol Hepatol. 2017 Jun;14(6):356-365. doi: 10.1038/nrgastro.2017.20. Epub 2017 Mar 8.

  PMID: 28270698 BACKGROUND

• Zou S, Fang L, Lee MH. Dysbiosis of gut microbiota in promoting the development of colorectal cancer. Gastroenterol Rep (Oxf). 2018 Feb;6(1):1-12. doi: 10.1093/gastro/gox031. Epub 2017 Oct 11.

  PMID: 29479437 BACKGROUND

• Gopalakrishnan V, Helmink BA, Spencer CN, Reuben A, Wargo JA. The Influence of the Gut Microbiome on Cancer, Immunity, and Cancer Immunotherapy. Cancer Cell. 2018 Apr 9;33(4):570-580. doi: 10.1016/j.ccell.2018.03.015.

  PMID: 29634945 BACKGROUND

• Ferreira MR, Muls A, Dearnaley DP, Andreyev HJ. Microbiota and radiation-induced bowel toxicity: lessons from inflammatory bowel disease for the radiation oncologist. Lancet Oncol. 2014 Mar;15(3):e139-47. doi: 10.1016/S1470-2045(13)70504-7.

  PMID: 24599929 BACKGROUND

• de Souza DL, Curado MP, Bernal MM, Jerez-Roig J, Boffetta P. Mortality trends and prediction of HPV-related cancers in Brazil. Eur J Cancer Prev. 2013 Jul;22(4):380-7. doi: 10.1097/CEJ.0b013e32835b6a43.

  PMID: 23238584 RESULT

• Morris VK, Salem ME, Nimeiri H, Iqbal S, Singh P, Ciombor K, Polite B, Deming D, Chan E, Wade JL, Xiao L, Bekaii-Saab T, Vence L, Blando J, Mahvash A, Foo WC, Ohaji C, Pasia M, Bland G, Ohinata A, Rogers J, Mehdizadeh A, Banks K, Lanman R, Wolff RA, Streicher H, Allison J, Sharma P, Eng C. Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Apr;18(4):446-453. doi: 10.1016/S1470-2045(17)30104-3. Epub 2017 Feb 18.

  PMID: 28223062 RESULT

• James RD, Glynne-Jones R, Meadows HM, Cunningham D, Myint AS, Saunders MP, Maughan T, McDonald A, Essapen S, Leslie M, Falk S, Wilson C, Gollins S, Begum R, Ledermann J, Kadalayil L, Sebag-Montefiore D. Mitomycin or cisplatin chemoradiation with or without maintenance chemotherapy for treatment of squamous-cell carcinoma of the anus (ACT II): a randomised, phase 3, open-label, 2 x 2 factorial trial. Lancet Oncol. 2013 May;14(6):516-24. doi: 10.1016/S1470-2045(13)70086-X. Epub 2013 Apr 9.

  PMID: 23578724 RESULT

• Ambalam P, Raman M, Purama RK, Doble M. Probiotics, prebiotics and colorectal cancer prevention. Best Pract Res Clin Gastroenterol. 2016 Feb;30(1):119-31. doi: 10.1016/j.bpg.2016.02.009. Epub 2016 Feb 19.

  PMID: 27048903 RESULT

• Braghiroli MI, Mota JM, Duarte PS, Morita TO, Bariani GM, Nebuloni D, Buchpiguel CA, Hoff PM, Riechelmann RP. Evaluation of 18F-FDG PET-CT as a prognostic marker in advanced biliary tract cancer. Nucl Med Commun. 2018 Mar;39(3):252-259. doi: 10.1097/MNM.0000000000000810.

  PMID: 29381586 RESULT

MeSH Terms

Conditions

Anus Neoplasms

Interventions

Prebiotics; Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• Rachel SP Riechelmann, MD

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel SP Riechelmann, MD

CONTACT

+55 (11) 2189-5000; rachel.riechelmann@accamargo.org.br

Mauro DS Donadio, MD

CONTACT

+55 (11) 2189-5000; maurodsd@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Departament of Clinical Oncology

Model Details: 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

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 12, 2019
• Study Start: March 13, 2019
• Primary Completion: August 13, 2023
• Study Completion: February 11, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)