Lifestyles Implemented-Survivorship Care Plan in Lymphoma Survivors

Launched by FONDAZIONE ITALIANA LINFOMI - ETS · Jun 28, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a healthy lifestyle can improve the quality of life for people who have survived certain types of lymphoma—specifically, classical Hodgkin lymphoma and two forms of large B-cell lymphoma. The study involves lymphoma survivors who have been in remission for at least three years but no more than ten years since their last treatment. To be eligible, participants should be between 18 and 50 years old, have been diagnosed with one of the targeted lymphomas, and have completed their first-line treatment successfully.

Participants in the trial will follow a survivorship care plan that promotes healthy living. This plan may include advice on diet, exercise, and other lifestyle changes to enhance well-being. The study is currently recruiting participants and involves visits to healthcare facilities for assessments and follow-ups. It’s important to note that those with certain health conditions, like severe heart issues or recent serious medical events, may not be eligible. Overall, this trial aims to help lymphoma survivors lead healthier, happier lives after their treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18-50 at initial treatment;
• • Diagnosis of classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL) or Primary mediastinal large B-cell lymphoma (PMBCL);
• • Patients in Complete Remission (CR) after first-line therapy \[ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) or BEACOPP (bleomycin, etoposide, doxorubicin , cyclophosphamide, vincristine, procarbazine and prednisone) or ABVD-BEACOPP Pet-2 guided treatment for cHL; R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine and prednisone) for DLBCL; R-CHOP or R-DA-EPOCH (rituximab- Dose Adapted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) for PMBCL);
• • Patients in remission for a minimum 3 years since the last treatment and a maximum of 10 years;
• • Cumulative doxorubicin/ adriamycin dose received of at least 200 mg/mq (4 cycles of chemotherapy);
• • Availability echocardiogram (ECG) and 2D-STE-echocardiography (Two-dimensional speckle strain echocardiography) performed no later than three months prior to enrollment;
• • Signature of a written informed consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate voluntarily in the study.
• Exclusion Criteria:
• • Diagnosis of secondary cancer at baseline, except non-melanoma skin cancers and adequately treated cone-biopsied in situ carcinoma of the cervix;
• • Second line chemotherapy of stem cell transplant;
• • Not able to perform physical activity;
• • Grade \>/=3 neuropathy;
• • Vertebral fractures or stenosis of the vertebral canal; other bone fracture;
• • Cardiovascular disease: arrhythmia \>/= grade 2, hypertension \>/ grade 2, left ventricular dysfunction \>/= grade 2 pericardial disease/effusion any grade, myocarditis any grade, pulmonary hypertension any grade, restrictive cardiomyopathy any grade valvular hearth disease \>/= grade 2, right ventricular dysfunction \>/= grade 2;
• • Venous thromboembolism or arterial thrombosis during last 6 months;
• • Hemorrhage/ bleeding \>/= grade 2 during last 6 months;
• • Chronic lymphedema (arms and/ or limbs);
• • Rheumatic disease or inflammatory bowel disease in systemic treatment;
• • Any pleural effusion;
• • If female, the patient is pregnant;
• • Unwilling to comply to all required visits and procedures for the duration of study participation