Clinical trial · Interventional
Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy SCC of the Anal Canal (BISQUIT)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer Squamous Cell | Anal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prebiotics in combination with probiotics | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Prebiotics and probiotics group
- description
- 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).
- interventionNames
- Dietary Supplement: prebiotics in combination with probiotics
- type
- NO_INTERVENTION
- label
- Control group
- description
- This group will lead nutritionally based just before starting Ch-RT.
Primary outcomes (1)
- measure
- Response rate (clinical and radiological)
- timeFrame
- Six to eight weeks from the end of Ch-RT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDNiederreiter 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
- BACKGROUNDScott 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
- BACKGROUNDAlexander 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
- BACKGROUNDZou 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
- BACKGROUNDGopalakrishnan 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
- BACKGROUNDFerreira 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
- RESULTde 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.