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70 Years
Open (Enrolling)
Cancer, Elderly Population

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Trial Information

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.

Inclusion Criteria:

- 70 years old or older

- Curative cares for cancer by chemotherapy and/ or surgery and/or hormonotherapy and/
or radiotherapy

- Patient with histologically proven lymphoma or carcinoma :

- Colon, rectum or anal canal Cancer

- Breast Cancer

- Esophageal cancer

- Otolaryngology Cancer

- Kidney cancer

- hepatocellular carcinoma

- Stomach Cancer

- Pancreatic cancer

- Bile duct cancer

- Ovarian Cancer

- All lymphoma diffuse large B-cell and all peripheral T-cells lymphomas

- All low-grade lymphoma: lymphocytes, lymphocytes and plasma cells, follicular,
mantle, marginal zone (MALT and others)

- Prostate cancer

- Bladder Cancer

- Lung cancer

- adenocarcinoma of unknown primary origin compatible with previous quoted origin

- Performance status (ECOG) <4

- Patient who had given oral consent to participate in the study

Exclusion Criteria:

- Palliative cares for cancer

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

SPPB Score

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Bordeaux, France


France: Ministry of Health

Study ID:

CHUBX 2010/23



Start Date:

October 2011

Completion Date:

October 2015

Related Keywords:

  • Cancer
  • Elderly Population
  • cancer
  • geriatry
  • curative care
  • physical activity