Physical Activity Advices to Prevent Loss of Autonomy in Cancer Treated Elderly Patients. An Intervention Randomized Study (CAPADOGE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cancer Elderly Population |
Other: Adapted physical activity Other: Classic physical activities |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
- SPPB Score [ Time Frame: 1 year ] [ Designated as safety issue: No ]The main outcome will be the proportion of subjects with a one-year decreased SPPB score of one point or more in 12.
- Cognitive skills [ Time Frame: 2 years ] [ Designated as safety issue: No ]MMS test, verbal fluency
- Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]IPAQ, QLQ-C30, ADL, performance status (ECOG)
- nutritional status [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Walking distance over 6 minutes [ Time Frame: inclusion, 6 months and 1 year ] [ Designated as safety issue: No ]
- isometric muscle strength measures of upper and lower limbs [ Time Frame: 2 years ] [ Designated as safety issue: No ]microfet2 test
- weight [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- SPPB score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Adaptated physical activity
Physical activity advices adaptated to physical status of patients
|
Other: Adapted physical activity
Physical activity advices according to a program adapted to physical status of the patient.
|
|
Standard physical activity
Daily physical activities based on a standard guide
|
Other: Classic physical activities
Daily physical activities based on a standard guide
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Isabelle BOURDEL MARCHASSON, Pr | 33 (0) 5 57 65 65 71 | isabelle.bourdel-marchasson@chu-bordeaux.fr |
| France | |
| Institut Bergonié | Not yet recruiting |
| Bordeaux, France, 33076 | |
| Contact: Marianne Fonck, Dr fonck@bergonie.org | |
| Principal Investigator: Marianne Fonck, Dr | |
| Centre Oscar Lambret, CLCC Lille | Not yet recruiting |
| Lille, France, 59020 | |
| Contact: Véronique Servent, Dr v-servent@o-lambret.fr | |
| Principal Investigator: Véronique Servent, Dr | |
| CHRU Lille | Not yet recruiting |
| Lille, France, 59000 | |
| Contact: Jean-Pierre Triboulet, Pr jp-triboulet@chru.lille.fr | |
| Principal Investigator: Jean-Pierre Triboulet, Pr | |
| CHU de Limoges, Hôpital Dupuytren | Not yet recruiting |
| Limoges, France, 87042 | |
| Contact: Sandrine Lavau-Denès, Dr sandrine.lavau-denes@chu-limoges.fr | |
| Principal Investigator: Sandrine Lavau-Denès, Dr | |
| Hospices civils de Lyon Sud | Not yet recruiting |
| Lyon, France, 69000 | |
| Contact: Marc Bonnefoy, Pr marc.bonnefoy@chu-lyon.fr | |
| Principal Investigator: marc Bonnefoy, Pr | |
| CHU Bordeaux - hôpital Xavier Arnosan | Recruiting |
| Pessac, France, 33604 | |
| Contact: Isabelle Bourdel-Marchasson, Pr 05 57 65 65 71 isabelle.bourdel-marchasson@chu-bordeaux.fr | |
| Contact: Jessica DURRIEU 05 57 65 66 72 jessica.durrieu@chu-bordeaux.fr | |
| Principal Investigator: Isabelle Bourdel-Marchasson, Pr | |
| Institut jean Godinot, CLCC Reims | Not yet recruiting |
| Reims, France, 51056 | |
| Contact: Brigitte Maget, dr Brigitte.maget@reims.fnclcc.fr | |
| Principal Investigator: Brigitte Maget, Dr | |
| Centre hospitalier de Senlis | Not yet recruiting |
| Senlis, France, 60309 | |
| Contact: Elisabeth Carola, Dr elisabeth.carola@ch-senlis.fr | |
| Principal Investigator: Elisabeth Carola, Dr | |
| Centre Alexis Vautrin CLCC Nancy | Not yet recruiting |
| Vandœuvre-Les-Nancy, France, 54511 | |
| Contact: Hubert Rousselot, Dr h.rousselot@nancy.fnclcc.fr | |
| Principal Investigator: Hubert Rousselot, Dr | |
| CHU Nancy hôpital adulte du brabois | Not yet recruiting |
| Vandœuvre-Les-Nancy, France, 54511 | |
| Contact: Philippe Feugier, Pr p.feugier@chu-nancy.fr | |
| Principal Investigator: Philippe Feugier, Pr | |
| Principal Investigator: | Isabelle BOURDEL MARCHASSON, Pr | University Hospital, Bordeaux, France |
| Study Chair: | Adélaïde DOUSSAU, Dr | University Hospital, Bordeaux, France |
More Information
No publications provided
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT01432067 History of Changes |
| Other Study ID Numbers: | CHUBX 2010/23 |
| Study First Received: | September 8, 2011 |
| Last Updated: | February 26, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Bordeaux:
|
cancer geriatry curative care physical activity |
ClinicalTrials.gov processed this record on May 23, 2013