Physical activity program for the survival of elderly patients with lymphoma (PHARAOM): a study protocol for a randomized phase III trial (Preprint)

BACKGROUND Older adults suffering from cancer receive a treatment that, in most cases, causes symptoms such as fatigue, weakness, sleep disturbances, and lethargy. Moreover, the toxicity of the chemotherapy itself can also affect the physical function and the quality of life of cancer patients. Since a poor general health status reduces the chances of survival and these patients are most likely to also suffer from sarcopenia, it is therefore important to be able to improve their physical function through adapted physical activity (APA) as part of a supportive care management. Unfortunately, APA is too often saved for patients in an advanced stage of blood cancer. As a result, there is a lack of data regarding the impact of a regular practice of physical activity (that is concomitant to the administration of chemotherapy) on cancer survival. OBJECTIVE The aim of this study is to assess a new and open rehabilitation program suitable for a frail population of patients that are treated for diffuse large B-cell lymphoma (DLBCL). METHODS PHARAOM (Physical Activity program for the survival of elderly patients with lymphoma) is a phase 3 (1:1) randomized study focusing on a frail population of patients treated for DLBCL. It will include a total of 186 elderly DLBCL patients (aged over 65 years) receiving rituximab plus cyclophosphamide, hydroxydaunorubicin, vincristine, and prednisone (R-CHOP); of these, 93 patients (the investigational group) will receive APA that will be supervised by a dedicated qualified kinesiologist, in addition to chemotherapy. The primary endpoint of this study will be the patients’ event-free survival. Secondary endpoints will include the overall survival, the progression-free survival, the prevalence rates of sarcopenia and undernutrition, as well as the patients’ quality of life. RESULTS The study has been approved by the internal Ethical Committee, and was registered as a clinical trial (NCT04670029) on December 16, 2020. The study will be undertaken in accordance with the Declaration of Helsinki. CONCLUSIONS This study will highlight the benefits of regular APA on the survival of patients treated for a DLBCL. This study could also contribute to our understanding of how an adapted physical program can reduce sarcopenia in cancer patients, and improve their quality of life. By documenting the prevalence and the relationship between sarcopenia and exercise load, we might be able to help physicians to plan better interventions in DLBCL patients. CLINICALTRIAL Clinical Trial: NCT04670029