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

  • STATUS
    Recruiting
  • days left to enroll
    37
  • participants needed
    40
  • sponsor
    Centre Leon Berard
Updated on 4 October 2022
cancer
myeloid leukemia
hematologic malignancy
lymphoma
hodgkin's disease
leukemia
azacitidine
venetoclax

Summary

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.

Details
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

Eligibility

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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