Neoplasms

Blood and Lymph Conditions

All Conditions

Symptoms and General Pathology

Hematologic Neoplasms

Frailty

Hematologic Diseases

Patients in the intervention group will follow the standard treatment and follow-uo according to the clinical protocol of the institution and will participate in an intervention program with physical exercise and nutritional support during the period in which they are receiving oncological treatment or for a maximum period of 6 months.

The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.

Nutritional support will be given to all patients according with their nutritional body composition parameters (Nutritional assessment and sarcopenia evaluation). It could be diet counselling, oral supplemented nutrition, enteral nutrition o parenteral nutrition.

Nutritional support

The exercise program, designed, applied and monitored by research staff of the Physiology Unit, will have duration of 24 weeks (6 months). The program will have a mixed structure, the participants in an individual way fulfill their training and attend group sessions (8 subjects). In addition, 3 days a week should conduct sessions that will focus on the work of balance and general strength.

Physical exercise

Hematologic Drug

Maite Antonio, MD, PhD

Josep Maria Borras, MD,PhD,Prof

Maite Antonio, MD,PhD

Clinical trial to analyze the impact of nutrition and physical exercise intervention program on the completion of treatment in older patients 70 years or older with malignant hemopathology

OBJECTIVE:

This study aims to determine wether a geriatric intervention based on an individualized program of physical exercise and nutritional support improves the ability to complete oncological treatment at the doses and time initially planned in patients ≥ 70 years affected by hematological malignancies.

DESIGN:

Prospective, clinical trial, randomized, parallel and open groups.

SETTING:

Patients ≥ 70 years recently diagnosed of malignant hematological pathology in a comprehensive cancer center

INTERVENTION:

All those patients who meet the inclusion criteria and agree to participate, will sign the corresponding informed consent and will be assessed through a CGA (comprehensive geriatric assessment), that includes the performance of a physical condition test (SPPB), and randomized to the study group or control group. Patients in the study group will participate in an intervention program with nutritional support and physical exercise during the period in which they are receiving oncological treatment or for a maximum period of 6 months. The patients of the control group will pass to follow up. All patients, regardless of the branch of study to which they are assigned, will receive the oncological treatment indicated by their doctor and a standard follow-up according to the current care protocols in the center.

DETERMINATIONS:

Main variable: proportion of adherence to treatment calculated as the percentage between the dose administered and the prescribed. Adherence over 80% will be considered acceptable.

Secondary variables: geriatric, nutritional and physical-condition parameters before and after the intervention, quality of life before and after the intervention, toxicity and complications during treatment and response to treatment.

Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies

Impact of a Nutritional and Physical Exercise Intervention Program on Oncological Treatment Completion in Patients ≥70 Years Old With Malignant Hemopathies:ICOSENIORHEM Randomized Clinical Trial

Percentage between the dose administered and the prescribed.

Vulnerable Elders Survey (VES-13) (numeric variable)

Geriatric Assessment in Hematology (GAH scale) (numeric variable)

Mini-Nutritional Assessment (MNA) (numeric variable)

Basic activities of daily life (ABVD) - (Barthel scale) and instrumental activities of daily life (IADL) (Lawton-Body scale), fatigue (Borg scale) (numeric variable)

Short Portable Physical Performance (SPPB) test. Numeric variable.

Walking test 4 metres, Up-and-go test (seconds)

Weight and height will be combined to report body mass index (BMI) in kg/m2

Anthropometric evaluation of waist, hip, arm, thigh and leg perimeters (cm).

Body mass measured with electrical bioimpedance

Strength measured by Isometric dynamometry of hands (hand grip) and legs (flex-extension) (KgF)

6-minute walk test to assess functional capacity.

Number of exercise sessions completed by each participant in the intervention group.

Frequency and severity of adverse effects according to CTCAE v4.

Quality of Life Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)for old patients with cancer. (EORTC QLQ-ELD14): numeric variable.

Time to treatment failure, time to disease progression or death from any cause, and time to disease progression

Disease-free survival, overall survival, and cancer-specific survival.

Institut d'Investigació Biomèdica de Bellvitge

University of Barcelona

Instituto de Salud Carlos III

Maite Antonio, MD, Phd

Coordinator Oncohematogeriatrics Unit. Institut Català d'Oncologia

Rare Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Dermatologic Agents

Azacitidine

Tretinoin

Antimetabolites

Enzyme Inhibitors

Keratolytic Agents

Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle with ATRA 20mg tid by po on days 1-21 of every cycle 28 days

Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle

Azacytidine 75mg/m2/d by IV on days 1-7 of every cycle 28 days

ATRA 20mg tid by po on days 1-21 of every cycle 28 days

all trans retinoic acid

Han Yue, Ph.D

Wu Depei, Ph.D

Yue Han, professor

This is a randomized, open-label, multicenter study to compare the efficacy and safety of AZA with or without ATRA in newly diagnosed unfit AML or Intermediate,High or Very High Risk MDS

Newly diagnosed unfit AML and Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria are unable to tolerate the intensive chemo-therapy regimens due to their old age and poor physical condition, resulting in limited overall survival. Nowadays, AZA are recommended for unfit acute myeloid leukemia or myelodysplastic syndromes patients with remission rate of 30%\~34%. AZA with or without all-trans retinoic acid (ATRA) can cooperatively inhibit leukemia cell proliferation , induce apoptosis and differentiation.

Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS

Azacitidine in Combination With or Without All-trans Retinoic Acid in Newly Diagnosed Unfit Acute Myeloid Leukemia or Intermediate,High or Very High Risk Myelodysplastic Syndromes (MDS) as Per IPSS-R Criteria

Number of participants (responders) achieving ORR after the 6 cycle treatments，Overall response rate (ORR) based on the International Working Group (IWG)-2006 criteria, which include complete remission (CR), partial remission (PR), and major hematologic improvement (HI).

time from randomization to death from any cause, or last known date to be alive.

Progression-free survival (PFS) will be measured from time of enrolling in the clinical trial to the date on which disease progresses or the date on which the patient dies, whichever comes first.

TI is when the participants who were transfusion dependent on RBC and/or Platelet at baseline achieve transfusion independence post baseline. TI is a period of at least 56 days with no transfusion after the date of the first dose of study drug to the last dose of study drug + 30 days, the initiation of post-treatment therapy, or death, whichever is earliest.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies	NCT04057443	Hematologic Mal... Old Age; Debili...	Nutritional sup... Physical exerci... Hematologic Dru...	70 Years -	L'Hospitalet de Llobregat
Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies	NCT04057443	Hematologic Mal... Old Age; Debili...	Nutritional sup... Physical exerci... Hematologic Dru...	70 Years -	L'Hospitalet de Llobregat
Aza With or Without ATRA in Newly Diagnosed Unfit AML or Intermediate,High or Very High Risk MDS	NCT05175508	AML MDS Old Age; Debili... Hematologic Can...	Azacitidine all trans retin...	18 Years - 80 Years	The First Affiliated Hospital of Soochow University

Spots Global Cancer Trial Database for old age; debility