An Individualized Physical Activity Program in Patients Over 65 Years With Hematologic Malignancies (OCAPI)

  • days left to enroll
  • participants needed
  • sponsor
    Centre Leon Berard
Updated on 4 October 2022
myeloid leukemia
hematologic malignancy
hodgkin's disease


Older people with cancer differ from younger patients due to the combined effects of aging, comorbidities and cancer treatments on their health. In acute myeloid leukemia (AML) and non-hodgkin lymphoma (NHL), chemotherapy, which is the main treatment, is associated with significant toxicity that negatively affects patients' physical capacities and quality of life, already declining with age and comorbidities. It therefore seems essential to develop and evaluate interventions that can prevent physical and psychosocial decline and its consequences in these populations. However, no studies have evaluated a physical activity (PA) program among these populations, although the absence of risk of implementing PA during intense therapeutic procedures has been confirmed.

OCAPI is an interdisciplinary, prospective, interventional, feasibility study. It is intended to include 20 AML and 20 NHL patients 65 years of age or older at the time of initiation of the first chemotherapy line, with an ECOG <3, with no contraindications to PA and no history or coexistence of other primary cancer.

Expected results are to demonstrate that a program offering supervised sessions in a sterile room or at home and remote support can enable patients with AML or NHL to perform their daily PA in autonomy. All these results will generate preliminary data before implementing a larger national study.

Condition Aged, Aged, 80 and Over, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Exercise, Quality of Life, Fatigue
Treatment Individualized physical activity program
Clinical Study IdentifierNCT04052126
SponsorCentre Leon Berard
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Age 65 and over
With histologically confirmed non-Hodgkin's lymphoma (NHL) or acute myeloid leukemia (AML)
Requiring a first line of chemotherapy treatment or Azacitidine - Vénétoclax combination
Followed-up in one of the investigating centers
Residing in one of the following departments: Ain, Ardèche, Drôme, Isère, Loire, Rhône, Savoie, Haute-Savoie
Having a ECOG < 3
With a life expectancy > 6 months
Whose ability to engage in physical activity has been certified by a medical certificate issued by the investigator physician
Available and willing to participate in the study for the duration of the intervention and follow-up
Able to understand, read and write French
Affiliated with a social security scheme
Having dated and signed an informed consent

Exclusion Criteria

Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years)
Treated by immunotherapy alone
Participating in concurrent physical activity studies
Deprived of their liberty by court or administrative decision
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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