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Study on the Effects of Imipramine in Patients with Colon, Rectal, or Breast Cancer Over-Expressing Fascin1

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying certain types of cancer, specifically colon cancer at stages II-III, rectal cancer, and breast cancer, which show high levels of a protein called Fascin1. The treatment being tested is a medication called Tofranil, which contains the active ingredient imipramine hydrochloride. The purpose of the study is to see if Tofranil can cause significant changes in the cancer cells from the time they are diagnosed until they are surgically removed.

Participants in the study will receive either Tofranil or a placebo, which looks like the medication but does not contain the active ingredient. The study will observe the effects of Tofranil on the cancer cells, particularly focusing on changes in the way the cells look and behave under a microscope. This includes examining the tumor's structure and the presence of certain immune cells around the tumor. The study will also measure the levels of tumor DNA in the blood and the amount of Fascin1 protein in the tissue removed during surgery.

The trial will take place over a period of time, with some patients being observed for 2-6 weeks and others for 3-6 months, depending on their treatment plan. The goal is to understand if Tofranil can help change the characteristics of the cancer cells, potentially leading to better treatment outcomes for patients with these types of cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the clinical trial, ensure that a written informed consent is provided. This confirms understanding and agreement to participate in the study.

    Eligibility includes having a resectable tumor and a diagnosis of colon, rectal, or triple-negative breast cancer with overexpression of Fascin1.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm the diagnosis and the overexpression of Fascin1 in the primary tumor through a biopsy.

  3. Step 3

    Medication administration

    The medication Tofranil (imipramine hydrochloride) will be administered in the form of a coated tablet.

    The dosage is 50 mg, taken orally. The frequency and duration of administration will be determined based on the group assignment.

  4. Step 4

    Treatment period

    For group A, the treatment period is usually between 2-6 weeks.

    For neoadjuvant patients in group B, the treatment period is between 3-6 months.

  5. Step 5

    Surgical resection

    After the treatment period, a surgical resection of the tumor will be performed.

    The main objective is to assess changes in the tumor's histological and molecular characteristics.

  6. Step 6

    Evaluation of results

    The primary endpoint is to observe changes in the tumor's invasive front, including tumor budding and immune cell characteristics.

    Secondary endpoints include evaluating plasma tumor DNA and Fascin1 expression in the surgical specimen.

Who can join the trial?

5 criteria

  • The tumor must be resectable, which means it can be removed by surgery.
  • You must provide Written Informed Consent, which is a document you sign to show you understand the study and agree to participate.
  • You must have a diagnosis of colon cancer, rectal cancer, or triple negative breast cancer confirmed by a biopsy, which is a small sample of tissue taken from the body for testing.
  • The primary tumor must show overexpression of Fascin1, meaning the tumor has higher levels of a specific protein called Fascin1.
  • You must be over 18 years of age.

Who cannot join the trial?

7 criteria

  • Patients with any other type of cancer not specified in the study.
  • Patients who have not been diagnosed with cancer that over-expresses Fascin1. Fascin1 is a protein that can be found in higher amounts in some cancer cells.
  • Patients who are not within the age range specified for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
  • Patients who are not able to undergo the required surgical procedures as part of the study.
  • Patients who are unable to comply with the study requirements or follow-up visits.
  • Patients who have any medical condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Tofranil is a medication that is being studied for its potential effects on cancer cells, specifically those that have high levels of a protein called Fascin1. In this clinical trial, researchers are looking at how Tofranil might change the way cancer cells behave and grow. The goal is to see if Tofranil can alter certain features of the cancer cells, which might help in treating the cancer more effectively. This medication is being tested to see if it can make a difference in the cancer's characteristics from the time it is diagnosed until it is surgically removed.

What is already known about the treatment

Tofranil – Tofranil is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential effects on certain types of cancer, specifically colon cancer stage II-III, rectal cancer, and breast cancer that over-express Fascin1. The main therapeutic indication is to evaluate its impact on the epithelial-mesenchymal transition (EMT) in cancer cells, which is a process that can contribute to cancer progression. At the molecular level, Tofranil is believed to influence cellular changes that may affect cancer growth. It is pharmacologically classified as a tricyclic antidepressant, but in this context, it is being explored for its potential anti-cancer properties.

Investigated diseases

  • Colon Cancer Stage II-III

    Colon cancer is a type of cancer that begins in the large intestine. In stages II and III, the cancer has grown through the wall of the colon and may have spread to nearby lymph nodes but not to distant sites. The disease progresses as cancer cells continue to grow and invade surrounding tissues. As it advances, it can cause symptoms like changes in bowel habits, abdominal pain, and blood in the stool. The progression can lead to further complications if the cancer spreads to other parts of the body.

  • Rectal Cancer

    Rectal cancer originates in the rectum, the last several inches of the large intestine. It progresses as the cancer cells grow and invade the wall of the rectum and potentially nearby lymph nodes. Over time, the disease can cause symptoms such as rectal bleeding, changes in bowel habits, and discomfort. As it advances, it may spread to other organs, complicating the condition. The progression of rectal cancer can lead to significant changes in bowel function and overall health.

  • Breast Cancer

    Breast cancer is a disease where malignant cells form in the tissues of the breast. It progresses as these cells grow uncontrollably and can spread to nearby lymph nodes and other parts of the body. The disease may initially present as a lump in the breast or changes in breast shape or texture. As it advances, it can cause symptoms like pain, swelling, and skin changes. The progression of breast cancer can affect the lymphatic system and other organs if not managed.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504943-15-00Protocol codeIMIB-HTF-2021-01Estimated enrolment180 patientsSponsorFundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

sourced from the EU Clinical Trials Register and site verification

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