Background Prognostic factors can impact the quality of life and overall survival in metastatic situations: sarcopenia and nutritional status disorders. Methods We conducted a non-interventional, observational prospective study during 3 consecutive months (SPACE trial, ClinicalTrials.gov identifier: NCT04714203). Performance status, lumbar skeletal muscle index (by CT scan), albumin, C-reactive protein, or LDH, were collected from medical records in the classic balance sheet at inclusion and then at 3 and 6 months after the day of inclusion. Results 38 patients were included with a median age of 68 years old and 31 were evaluable for sarcopenia. 58.1% of patients with metastatic cancer were sarcopenic at the diagnosis and 61% at 6 months. At the inclusion, 87.5% of sarcopenic patients were men (p < 0.0002) and sarcopenia status was associated with lung localization (p < 0.0332) and non-operable cancer (p < 0.0069). Conclusion The majority of patients in our study were sarcopenic at the inclusion and at 6 months. However, the number of patients was too small to correlate sarcopenia with survival. Further larger studies are needed to establish stronger results. In the future, sarcopenic patients could benefit from specialized care with nutrition and adapted physical activity.

Background The practice of regular physical activity can reduce the incidence of certain cancers (colon, breast, and prostate) and improve overall survival after treatment by reducing fatigue and the risk of relapse. This impact on survival has only been demonstrated in active patients with lymphoma before and after treatment. As poor general health status reduces the chances of survival and these patients are most likely to also have sarcopenia, it is important to be able to improve their physical function through adapted physical activity (APA) as part of supportive care management. Unfortunately, APA is often saved for patients with advanced blood cancer. As a result, there is a lack of data regarding the impact of standardized regular practice of APA and concomitant chemotherapy as first-line treatment on lymphoma survival. Objective This study aimed to assess the impact of a new and open rehabilitation program suitable for a frail population of patients 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 randomized (1:1) study focusing on a frail population of patients treated for DLBCL. The study will include 186 older adult patients with DLBCL (aged >65 years) receiving rituximab and chemotherapy. Overall, 50% (93/186) of patients (investigational group) will receive APA along with chemotherapy, and they will be supervised by a dedicated qualified kinesiologist. The APA program will include endurance and resistance training at moderate intensity 3 times a week during the 6 months of chemotherapy. The primary end point of this study will be event-free survival of the patients. The secondary end points will include the overall survival, progression-free survival, prevalence of sarcopenia and undernutrition, and patients’ quality of life. This study will be conducted in accordance with the principles of the Declaration of Helsinki. Results Recruitment, enrollment, and data collection began in February 2021, and 4 participants have been enrolled in the study as of July 2022. Data analysis will begin after the completion of data collection. Future outcomes will be published in peer-reviewed health-related research journals and presented at national congress, and state professional meetings. This publication is based on protocol version 1.1, August 3, 2020. Conclusions The PHARAOM study focuses on highlighting the benefits of APA intervention on survival during the period of first-line treatment of patients with DLBCL. This study could also contribute to our understanding of how an APA program can reduce complications such as sarcopenia in patients with lymphoma and improve their quality of life. By documenting the prevalence and relationship between sarcopenia and exercise load, we might be able to help physicians plan better interventions in the care of patients with DLBCL. Trial Registration ClinicalTrials.gov NCT04670029; https://clinicaltrials.gov/ct2/show/NCT04670029 International Registered Report Identifier (IRRID) DERR1-10.2196/40969

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