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Healthy Lifestyle Plan for Lymphoma Survivors

Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors: A Randomized Non-pharmacological Clinical Trial By The Fondazione Italiana Linfomi (FIL)

Not applicable Interventional Fondazione Italiana Linfomi - ETS · NCT05934084

This study is testing whether a special health plan that includes lifestyle changes and nutrition advice can help lymphoma survivors feel better after they've been in remission for a while.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment552 (estimated)
Ages18 Years to 50 Years
SexAll
SponsorFondazione Italiana Linfomi - ETS Academic / other
Drugs / interventionsrituximab, chemotherapy, cyclophosphamide, doxorubicin, prednisone
Locations40 sites (Ancona, Ancona and 39 other locations)
Trial IDNCT05934084 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a Survivorship Care Plan (SCP) that includes lifestyle modifications, nutritional guidance, and physical activity for long-term lymphoma survivors. Participants will be randomly assigned to either the intervention group, which follows the SCP for six months, or a control group that receives standard follow-up care without the SCP. Quality of life will be assessed using validated questionnaires at baseline, 6 months, and 12 months post-randomization. The study aims to determine if the SCP can improve the overall well-being of lymphoma survivors who have been in remission for at least three years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-50 who have been in complete remission from classical Hodgkin lymphoma, DLBCL, or PMBCL for 3 to 10 years.

Not a fit: Patients who are not in remission or who have not completed at least 3 years since their last treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the quality of life for lymphoma survivors.

How similar studies have performed: Other studies have shown promising results with lifestyle interventions in cancer survivorship, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Ancona, Ancona and 39 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Classical Hodgkin LymphomaDiffuse Large B Cell LymphomaPrimary Mediastinal Large B-cell LymphomaSurvivorship Care PlanLifestyles implemented-Survivorship Care PlanQuality of LifeLymphoma SurvivorsNutritional plan
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.