Physical activity advices adaptated to physical status of patients

Daily physical activities based on a standard guide

Physical activity advices according to a program adapted to physical status of the patient.

Adapted physical activity

Classic physical activities

Isabelle BOURDEL MARCHASSON, Pr

Adélaïde DOUSSAU, Dr

The investigators will propose to older cancer patients with good prognosis (curative care) a randomized trial of adapted physical activity during one year. To increase generalisation of the intervention the investigators intend to compare the PNNS advices (the French National Nutrition and Health Program) to a program targeted on the own capacities of each patient.

Long-term evolution of successful-treated older patients is not well-known except for survival. They seem more affected by physical than psychological problems. The combined effects of aging, cancer, and treatments on muscle function could have hindered their usual physical activity. Cancer is associated with frailty. Fried and coll have defined a frailty phenotype as a combination of 3 or more of 5 conditions: exhaustion, loss of weight, decreased muscle strength, slow gait speed and low physical activity. Frail subjects have a higher risk of physical or cognitive disability and death. An intervention able to prevent frailty is of great interest for the older cancer patient and their quality of life. An intervention consisting of phone-program in physical activity has been associated with a decrease in self-reported disability in five-year obese survivors from cancer.

Patients will be randomized in two arms (1:1 ratio). Arm 1: Physical activity advices according to a program adapted to physical status of the patient assessed using SPPB (short physical performance battery) and the IPAQ questionnaire. A monthly phone support during one year will be performed by an adapted physical activity instructor and delivery of PNNS guide for subjects older than 55 y old. Arm 2: Delivery of PNNS guide for subjects older than 55 year old: recommendation of 1/2 hour physical activity of any kind.

Each patient will be followed during 2 years: First visit (V1) will take place before treatment. The subsequent visits will take place at 3 months (V2), 6 months (V3), 1 year (V4), 18 months (V5) and 2 years (V6), in which patients will complete questionnaires (IPAQ, QLQ-C30, one day dietary intakes), have clinical examinations (weight, performance status/ ECOG) and will be tested for physical facilities (SPPB, micro-fet2). These evaluations will be completed by the MMS / Fluency tests and the covered distance during 6 minutes at V1, V3, and V4.

Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study

The main outcome will be the proportion of subjects with a one-year decreased SPPB score of one point or more in 12.

IPAQ, QLQ-C30, ADL, performance status (ECOG)

University Hospital, Bordeaux

Neoplasms

All Conditions

Symptoms and General Pathology

Carcinoma, Squamous Cell

Frailty

Recurrence

Neoplasms, Squamous Cell

Carcinoma

Disease Attributes

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Cetuximab

Fluorouracil

Antineoplastic Agents, Immunological

6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w)

Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity

Carbo, 5FU, Cetuximab

The aim of the trial is to evaluate the clinical benefit (efficacy, safety, preservation of autonomy) of cetuximab-carboplatin-5FU combination as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma in patients over 70 years without frailty (after geriatric assessment).

Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC

Phase II Multicenter Trial Evaluating First Line Carboplatin, 5-Fluorouracil and Cetuximab in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Cancer, Aged 70 and Over, Ranked as Fit (no Frailty) by Geriatric Assessment

Objective tumor response at 12 weeks, safety (no grade 3, 4, 5 toxicities) and preservation of geriatric autonomy (absence of 2 or more points decrease on the Activities of Daily Living (ADL) scale) 1 month after the end of chemotherapy

Best objective tumor response during treatment

Duration of response under cetuximab maintenance therapy

Toxicity of cetuximab maintenance therapy

Autonomy assessed by ADL and IADL scales during treatment and until 1 month after the end of treatment

Quality of life assessed by EORTC QLQ-C30 and QLQ-HN35 questionnaires

Gustave Roussy, Cancer Campus, Grand Paris

Groupe Oncologie Radiotherapie Tete et Cou

Gaëtan GAVAZZI, PHD

Isabelle MARTY

Pascale GUILLEM, PHD

As the french population is ageing, the question of medical care in elderly cancer patients is fundamental. A third of all cancer patients are 70 years or older. This population has specific challenges: autonomy maintenance, treatments efficacy with limited side effects.

As a result of a call to projects, the Geriatric Oncology unit of the French Alps (UCOGAlp) has been selected by the National Institute of Cancer (INCa). It includes 15 centres in the Alpine area. This unit has been evaluated patients since 2011, giving them a full geriatric evaluation and trying to establish adapted cares.

In order to evaluate the impact of those evaluation on patients' health, the investigators have developped a geriatric follow-up after 1 month (D30) and 4 months (D120).

The investigators want to develop a common data base to these centres, in order to evaluate the care practices that were developped, and demonstrate the benefit for the patient on the dependence level and the overall survival.

There is a fundamental question nowadays about elderly cancer patients and how investigators can take care of them best. As the French National Institute for cancer stated, a third of all cancers are diagnosed for people over 70 years old. There are specificities for those patients: autonomy maintenance, treatments efficacy with minimum side effects.

This is why the Alpine Unit for Geriatric Oncology (UCOGAlp) was opened, and answered to a national call to projects. It includes 15 hospitals upon the East side of the Rhone-Alpes state. Since 2012, this unit evaluates, according to geriatric oncology validated tests, cancer patients that are 70 years old and older, so they can benefit from an adequate care plan. The need for a geriatric evaluation is determined by the Oncodage test (G8), or on clinical data.

The investigators wanted to see the impact of those initial evaluations, and so the centres developed follow-ups at day 30 and day 120. Investigators want to create a database that gathers the informations from the centres, to evaluate the care practices that were developed, and prove the benefit of such care for the patients, also on physical dependence and overall survival. This will allow new research paths in the field of geriatric oncology.

This study is an observational descriptive one, multicenter, using prospective data for the geriatric oncology as defined by the UCOGAlp.

It is asking the question of registering care practices in several centres of the Alpine valley that have a geriatric consultation, for elderly cancer patients.

The main outcome is the number of follow-ups of patients at 4 months (D120). The secondary outcomes are the adequation between the treatment that is suggested by a committee, the geriatrician's opinion, and the given treatment, the risk factors associated with dependence, and the overall survival.

The patients that are 70 years and older, recently diagnosed with cancer, are included in the study. They have an initial evaluation of their diseases, the autonomy level, a few biological data (hemoglobin, albumen, renal function), other diseases of the patient (and if they have any effect on his autonomy), the treatment that is chosen by specialists. Then there are the follow-ups with the same questions at D30 and D120. The investigators also want to collect data on overall survival after a 2-year follow-up.

The investigators want the analyze from this data to be the start of many projects in geriatric oncology, whether it is for survival or decision of treatment.

Geriatric Oncology Follow-up in the Alpine Valley

Description and Evaluation of Care Practices Amongst Geriatric Oncology Unit in the Alpine Valley, in the Follow-up of Cancer Patients.

Change in number of geriatric follow ups at D30 and D120

According to a scale of autonomy that is validated , the Instrumental Activities of Daily Living (ranges from 0 to 8/8, o being no abilities to use any instruments and 8 being able to use all kind), and the Activities of Daily Living (0 to 6/6, 0 is being completely depending on others for every day activities like eating or bathing, 6 is being completely autonomous).

We evaluate the mortality for all causes amongst the patients, with subgroups according to the treatment choices

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study	NCT01432067	Cancer Elderly Populat...	Adapted physica... Classic physica...	70 Years -	University Hospital, Bordeaux
Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC	NCT01864772	Metastatic or R...	Carbo, 5FU, Cet...	70 Years -	Groupe Oncologie Radiotherapie Tete et Cou
Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC	NCT01864772	Metastatic or R...	Carbo, 5FU, Cet...	70 Years -	Groupe Oncologie Radiotherapie Tete et Cou
Phase II Trial of Carboplatin, 5-FU and Cetuximab in Elderly Fit (no Frailty) Patients With Recurrent/Metastatic HNSCC	NCT01864772	Metastatic or R...	Carbo, 5FU, Cet...	70 Years -	Groupe Oncologie Radiotherapie Tete et Cou
Geriatric Oncology Follow-up in the Alpine Valley	NCT03349229	Oncology Aging		70 Years -	University Hospital, Grenoble
Geriatric Oncology Follow-up in the Alpine Valley	NCT03349229	Oncology Aging		70 Years -	University Hospital, Grenoble

Spots Global Cancer Trial Database for geriatry

Every month we try and update this database with for geriatry cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for geriatry

Every month we try and update this database with for geriatry cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for geriatry cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.