Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.

Geriatric intervention

Torgeir B Wyller, Dr.med

This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized perioperative intervention.

The main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.

Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer

Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.

Number of patients in need of any operation within thirty days after the operation for colorectal cancer.

Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.

Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.

Norwegian Cancer Society

University Hospital, Akershus

Oslo University Hospital

Professor

Symptoms and General Pathology

Colonic Neoplasms

Syndrome

Frailty

Herbal and Botanical

All Drugs and Chemicals

Cola

A comprehensive geriatric assessment and intervention, including exercise program.

Julia S Johansen, MD, PhD

The GEPOC study investigates the effect of comprehensive geriatric assessment and intervention for frail older patients (65 years or older) undergoing elective surgery for colorectal cancer. the geriatric intervention will be pre- and postoperative. included in the intervention is an exercise intervention.

The main aim of the study us to see if the functional decline in this group can be reduced.

This is a randomized, controlled trial on frail older patients (aged 65 years or older) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized intervention. Patients in the intervention group will participate in planned exercise programs before surgery, perioperative and postoperative.

Physiotherapist assessing function status.

Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer

functional test measuring lower body strength

EORTC European Organisation for Research and Treatment of Cancer questionnaire C30 (30-126 points where 30 is the worst)

EORTC European Organisation for Research and Treatment of Cancer questionnaire conjoined with ELD14 (Elderly Cancer Patient module) (14-54 points where 54 is the worst)

Measured with the questionnaire: Quality of Recovery - 15 questionnaire (0-150 points where 0 points is the worst)

measured by dual-energy x-ray absorptiometry

the concentration of CRP (CRP C-reactive Protein)

the concentration of YKL-40 (YKL-40 is also known as Chitinase-3-like protein 1)

the concentration of 92 proteins associated with immuno-oncology (OLink)

the concentration of GDF-11 (GDF Growth Differentiation Factor)

the concentration of GDF-15 (GDF Growth Differentiation Factor)

Measured with Clavien Dindo classification (grade I-V where grade V is death)

Number of patients being readmitted to hospital within 30 + 90 days after operation for colon surgery.

according to guidelines, if physical condition allows it (and patient accepts it).

Velux Fonden

University of Copenhagen

Herlev and Gentofte Hospital

MD, Principal Investigator, Department of internal Medicine

Blood and Lymph Conditions

Hematologic Neoplasms

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

Behaviors and Mental Disorders

Quality of Life

Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions) and QoL EORTC Q30 (Quality Qf Life with 30 Questions)

for patients with G8 score \> 14/17

Evaluation of quality of life with the EORTC QoL ELD 14 (Quality Qf Life ELDerly patients) and QoL (Quality Qf Life) EORTC Q30 for patients with G8 score ≤14/17 ( in this arm there is two groups : patient who received geriatric intervention before treatment initiation (group A) and group of patient did not received geriatric intervention before treatment initiation( group B))

geriatric intervention

Blandine De Lavigerie, MD

The aim of this study is to describe the impact of : Geriatric intervention contribution on quality of life of elderly patients receiving systemic treatments for metastatic neoplasia

Elderly cancer incidence increases exponentially with advancing age. However, elderly patients are largely underrepresented in cancer treatment trials. The geriatric population presents particular physical, mental, psychological or social specificities that may condition the prognosis especially for patients with metastatic neoplasia. Recently, the measurement of quality of life (QoL) in aging population is being recognized as an important part of clinical decision. It is therefore essential to set up prospective studies to evaluate the impact of oncogeriatric practices on the quality of life of elderly patients with metastatic neoplasia. The main objective of this prospective study is to describe the contribution of geriatric intervention on quality of life for for elderly (\> 75 years) with metastatic solid cancer receiving systemic treatment during the first 6 months of their therapeutic management.

Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia

Description the Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia : Prospective Descriptive Non-comparative Cohort ( QUALI Cohort)

Level of quality of life will be measured with the QoL ELD 14 (Quality Qf Life ELDerly patients with 14 Questions)

Level of quality of life will be measured with the QoL Q30 (Quality Qf Life with 30 Questions)

number of hospitalizations will be reported

Duration of hospitalizations will be reported in hours

Number of toxicities (grade 3 and 4) will be reported according to the CTCAE v4.0 (Common Terminology Criteria for Adverse Events)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer	NCT01321658	Colorectal Neop...	Geriatric inter...	65 Years -	Oslo University Hospital
Geriatric Assessment and Intervention in Older Patients Undergoing Surgery for Colorectal Cancer	NCT03719573	Colon Cancer Colon Neoplasm Frail Elderly S... Colorectal Canc...	Geriatric inter...	65 Years -	Herlev and Gentofte Hospital
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
Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia	NCT03743961	Systemic Treatm... Metastatic Neop... Elderly Patient...	geriatric inter...	75 Years -	Institut de Cancérologie de la Loire
Geriatric Intervention Contribution on Quality of Life of Elderly Patients With Metastatic Neoplasia	NCT03743961	Systemic Treatm... Metastatic Neop... Elderly Patient...	geriatric inter...	75 Years -	Institut de Cancérologie de la Loire

Spots Global Cancer Trial Database for geriatric intervention