In recent years, the painkiller methadone has come to the attention of the public as a supposedly promising cancer drug. Experimental studies (by Dr rer. nat. Claudia Friesen) have shown that methadone could prove to be an effective substance. The so-called opioid receptors on the surface of cancer cells are decisive for its effect. Methadone can attach itself to these receptors and exert its effect on the cell. Once docked, it ensured that the chemotherapeutic agents were able to penetrate the cells better in cell culture - the drugs thus worked more effectively, but so far this has only been confirmed in cell culture under laboratory conditions.

It is currently unknown whether and to what extent this effect of methadone can be transferred to a highly complex organism such as a human cancer patient compared to a cell culture. However, there is still no reliable data available for use in clinical practice and everyday treatment. As a result, it is currently scientifically unclear whether the addition of methadone to cytostatic cancer therapy (chemotherapy) improves the therapeutic outcome or merely causes more side effects.

For further background information on this, please refer to the detailed statement by German Cancer Aid on methadone in cancer therapy.

In principle, which patients can participate in the MEFOX study?

A clinical study can only be evaluated from a scientific point of view and only provides a gain in reliable knowledge if the patients have a minimum of the same characteristics with regard to their disease (stage, previous therapy, type of tumour). Therefore, unfortunately, not all patients fit into the MEFOX study.

Please use the following table to check whether you are potentially eligible to take part in the MEFOX trial. However, the final decision as to whether you are suitable is based on other medical parameters (e.g. laboratory values) and is the responsibility of the investigator in charge of the MEFOX trial.

Conditions for participation in the MEFOX study

If you have to answer one or more of the following points with "No", treatment within the framework of the MEFOX study is unfortunately not possible. In this case, please contact your treating oncologist/GI oncologist, who will certainly be happy to provide you with competent advice regarding your treatment options.

Please understand that, due to the lack of clinical-scientific proof of efficacy to date, no patients are being treated with methadone in cancer therapy outside of the MEFOX study at Ulm University Hospital. We therefore ask you to refrain from making enquiries in this regard.

However, if you would like to receive a second opinion on your treatment options (without methadone) from us, you are welcome to contact our "Comprehensive Cancer Center Ulm (CCCU)- Tumour Centre Alb-Allgäu-Bodensee" as before: sekr.cccu@uniklinik-ulm.de

Recruitment for the MEFOX study started in March 2022.

In addition to Ulm University Hospital, the MEFOX study is being conducted at 9 other centres (hospitals and oncology practices) throughout Germany. Participation is only possible at these MEFOX study centres. As soon as these locations have been finalised, they will be announced immediately on this page with contact details.

1. Ulm University Hospital
   Department of Internal Medicine I
   Oncological Study Secretariat
   Albert-Einstein-Allee 23
   89081 Ulm
   mefox.im1@uniklinik-ulm.de
   
2. University Medical Centre Hamburg-Eppendorf
   Prof. Dr Marianne Sinn
   ma.sinn@uke.de

As soon as further locations have been finalised, they will be announced immediately on this page with contact details.

The MEFOX study consists of 2 parts (Phase I and Phase II):

Phase I:

In this early study phase, small groups of patients (3-9 patients each, maximum planned: 18 patients) are treated with chemotherapy (FOLFOX every 14 days) and methadone solution (taken daily as drops at home), with the dose of methadone administered varying from group to group. The aim is to find the most tolerable dose of methadone in terms of its tolerability (toxicity) in combination with chemotherapy (dose-finding phase). This determined methadone dose will then be used for phase II of the study. The success of the anti-tumour therapy will be assessed every 12 weeks by means of cross-sectional imaging (CT or MRI).

Phase II:

In the randomised phase II, the planned 66 patients will be treated with the chemotherapy (FOLFOX every 14 days) and 2/3 of the patients will additionally be treated with the determined methadone dose from the first study phase (arm A). 1/3 of the patients receive chemotherapy without additional methadone therapy and represent the comparison group (arm B). Randomisation means that all patients are randomly assigned to one treatment arm (A or B). Your investigator has no influence on the allocation. The success of the anti-tumour therapy will be assessed every 12 weeks by means of cross-sectional imaging (CT or MRI).

Patients allocated to treatment arm B (chemotherapy without additional methadone therapy) can, however, change study arm at a later date (so-called crossover) and receive the combination of chemotherapy and methadone.

The medical and scientific director of the MEFOX study and thus head of the clinical trial is Professor Thomas Seufferlein, MD, Director of the Department of Internal Medicine I at Ulm University Hospital. He is supported by the study coordinator Dr Thomas J. Ettrich and a team of consultant physicians and scientists

The MEFOX study is fully funded by the German Cancer Aid Foundation, independent of industry.

AIO-Studien gGmbH is legally responsible for the MEFOX study (sponsor of the study in accordance with the German Medicines Act) and is a non-profit subsidiary of the "Arbeitsgemeinschaft Internistische Onkologie (AIO)" of the German Cancer Society.