Mitochondrial dysfUnction: a Key Player in Doxorubicin-induced Skeletal and Cardiac muscLE Damage

Launched by UMC UTRECHT · Feb 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a special imaging technique called Phosphorus-31 Magnetic Resonance Spectroscopy (31P-MRS) can help doctors see changes in the function of tiny structures in our cells called mitochondria. Mitochondria play a key role in providing energy to our muscles, including the heart and those in our legs. The trial focuses on patients who have large B-cell or T-cell lymphoma and are receiving a specific chemotherapy treatment known as (R-)CHOP. The main question the researchers want to answer is whether 31P-MRS can effectively monitor mitochondrial function in these patients during their treatment.

To participate in this study, patients need to be at least 18 years old and scheduled to receive six cycles of the (R-)CHOP chemotherapy. They should also be able to read and write in Dutch and have a good performance score, which means they are relatively healthy and able to carry out daily activities. Participants will undergo 31P-MRS imaging three times throughout the study, where they will be scanned while lying inside an MRI machine. It's important to note that certain medical conditions or devices, such as pacemakers or severe obesity, may prevent someone from joining the study. Overall, the trial aims to provide valuable insights that could help improve the understanding of treatment effects on muscle health in lymphoma patients.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Age ≥ 18 years
• • Patients with large B-cell lymphoma or T-cell lymphoma scheduled for 6 full-dose cycles of 1st line immunochemotherapy with cyclophosphamide, doxorubicin, vincristine and prednisone with or without rituximab ((reversed) (R-)CHOP).
• • WHO-performance score 0-2.
• • Patients with sufficient Dutch writing and reading skills.
• • Written informed consent.
• Exclusion Criteria:
• • Contra-indications for 7T MR scanning, including patients with a non-MRI compatible pacemaker, cochlear implant or neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; patients with a non-MR compatible aneurysm clip in their brain; patients with claustrophobia, and/or severe obesity.
• • Any circumstances that would impede adherence to study requirements or ability to give informed consent.
• • Medical disorders affecting mitochondrial function; e.g., spinal muscular atrophy.
• • (Other) relevant medical disorders; e.g., comorbidities affecting exercise tolerance.
• • Being under examination for non-diagnosed disease at the time of investigation.