RecruitingPhase 1ACTRN12624000455561

Safety and efficacy of faecal transplant and chemotherapy in the management of pancreatic cancer

Safety and efficacy of Faecal Microbiota Transplantation co-delivered with chemotherapy in improving pain, symptom management and treatment efficacy in patients with pancreatic cancer

Sponsor

Central Adelaide Local Health Network (CALHN)

Enrollment

60 participants

Start Date

Feb 28, 2025

Study Type

Interventional

Conditions

non-resectable pancreatic cancer

Summary

This study is investigating whether aiming to restore a healthy microbiota, gut barrier and digestion through faecal microbiota transplantation (FMT) alongside chemotherapy can effectively treat and relieve symptoms and pain in non-resectable pancreatic cancer. Who is it for? You may be eligible for this study if you are aged between 18 and 75 years of age, and have been diagnosed with non-resectable pancreatic cancer (i.e. pancreatic tumours that cannot be removed through surgery). Study details Participants will be randomly assigned to either receive FMT or placebo capsules in 2 separate treatment periods: one before chemotherapy and one 4 weeks after chemotherapy cessation. All participants will receive Folfirinox chemotherapy for either 3 or 6 months depending on the treating oncologist's review of their clinical response at 3 months. Safety, tolerability and efficacy data will be collected from participants over the course of their participation in this study. This study represents a unique opportunity to provide a novel and promising intervention for the management of pancreatic cancer and its symptoms to Australian patients to improve their health outcomes.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This Phase 1 study from Central Adelaide Local Health Network is investigating whether faecal microbiota transplantation (FMT) — transferring healthy gut bacteria from a donor — combined with standard chemotherapy can improve outcomes for people with pancreatic cancer that cannot be surgically removed. Pancreatic cancer has a poor prognosis, and researchers believe that improving the gut microbiome may help the body respond better to chemotherapy, reduce symptoms, and improve quality of life. Participants will receive either FMT capsules or placebo capsules at two time points — before chemotherapy and 4 weeks after it finishes. All participants will also receive Folfirinox chemotherapy. The study will assess safety, tolerability, and signs of whether FMT adds benefit to treatment. You may be eligible if you are aged 18–75, have non-resectable pancreatic cancer (meaning surgery is not an option), have a good functional status (ECOG 0–1), and are scheduled to receive Folfirinox chemotherapy. You would not be eligible if your tumour is operable, you have already started chemotherapy for this cancer, have significant bowel conditions, are immunocompromised, or are pregnant.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Faecal microbiota transplantation (FMT) as a co-treatment of chemotherapy with Folfirinox. FMT: Administered via oral capsules in two separate treatments. FMT will comprise whole stool anaerobicall

Faecal microbiota transplantation (FMT) as a co-treatment of chemotherapy with Folfirinox. FMT: Administered via oral capsules in two separate treatments. FMT will comprise whole stool anaerobically prepared and lyophilised from screened donors. Lyophilised, encapsulated FMT is supplied as 25g of lyophilised donor stool per 36 capsule dose (0.69g/capsule). FMT1: The first FMT treatment consists of a loading dose of 36 capsules taken over three days (12 capsules (0.69g/capsule)/day, total of 25g over three days). The patients will take 4 capsules with food at breakfast, lunch and dinner over the three days. This initial dose is provided before chemotherapy. FMT2: The second FMT treatment is done in two phases: - An initial loading phase: 36 capsules of FMT over three days (12 capsules/day). The patients will take 4 capsules with food at breakfast, lunch and dinner over the three days. - A consolidation phase: 3 capsules/day with food for 2 weeks. This second dose will be provided 4 weeks after chemotherapy cessation. Chemotherapy protocol: A script for Folfirinox will be provided with instructions on the day of FMT provision so that chemotherapy can commence two weeks after the first FMT treatment (week 0). A specific date of commencement will be marked on documentation to the patient and phone reminders will be provided by the trial team. The treating clinician will prescribe Creon (administered via oral tablets [2x25,000U] three times a day) to facilitate digestion during chemotherapy and afterwards. The participating oncologists will review the 3-month follow-up data to make a decision on the duration of chemotherapy. Depending on the patient’s response to chemotherapy (i.e., based on measurement of disease progression or regression that are part of the standard of care), Folfirinox will be prescribed for 3 or 6 months and taken every two weeks. The Folfirinox dosage will be as follow: • Oxaliplatin 85mg/m2 by intravenal infusion over 2 hours • Irinotecan 150mg/m2 by intravenal infusion over 90 minutes • Calcium folinate (Leucovorin) 50mg by intravenal bolus over 1 to 2 minutes • Fluorouracil 2,400mg/m2 delivered by intravenal infusion through a central line via pump over 46h

Locations(5)

The Queen Elizabeth Hospital - Woodville

SA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

SA,VIC, Australia

Epworth Richmond - Richmond

SA,VIC, Australia

Epworth Freemasons (Victoria Parade) - East Melbourne

SA,VIC, Australia

Epworth Eastern Hospital - Box Hill

SA,VIC, Australia

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ACTRN12624000455561