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Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer (CAPARFI)

Primary Purpose

Sarcopenia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ARFI
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcopenia focused on measuring Sarcopenia, ARFI, DEXA, Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Men or women 18 years old or more,
  • Able to understand the protocol and to give their written consent,
  • Health insurance.

Specific inclusion criteria:

  • Group A: volunteers 18 to 30 yrs; without any pathology,
  • Group B: volunteers ≥ 70 yrs; without any pathology,
  • Group C: Performance status (ECOG) < 4; patients included in CAPADOGE study presenting curative cares for cancer by chemotherapy and/ or surgery and/or hormonotherapy and/or radiotherapy.

Exclusion Criteria:

  • Intense activity in 7 preceding days,
  • Functional dependency,
  • under a legal protection.

Specific non-inclusion criteria:

  • Groups A & B: serious chronic disease,
  • Group C: Palliative care.

Sites / Locations

  • CHU Bordeaux - Hôpital Saint André
  • CHU de Bordeaux - Hôpital Haut-Lévêque

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Volunteers (18 -30 years)

Volunteers (70 years or older)

70 years patient or older with curative cares for cancer

Outcomes

Primary Outcome Measures

Viscoelasticity of the contracted Tibialis anterior muscle
Describe and compare the distribution curves of viscoelasticity of the contracted Tibialis anterior muscle, measured by the ARFI shear wave velocity, between each group.

Secondary Outcome Measures

Viscoelasticity of the contracted and relaxed Rectus femoris and Soleus muscles
Distribution curves of subcutaneous thickness in relaxed condition between each group on Rectus femoris and Soleus muscles
Compare fort each muscle the distribution curves of pennation angles in relaxed and contracted conditions between each group on Rectus femoris and Soleus muscles
Evaluate the influence of physical and/or nutritional status, age, and cancer pathology
Evaluate the intra-operator reproducibility

Full Information

First Posted
November 22, 2011
Last Updated
January 12, 2015
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01484821
Brief Title
Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer
Acronym
CAPARFI
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Sarcopenia is known to be associated with loss in muscle mass that results from a reduced number of muscle fibres, an atrophy of remaining muscle fibres, and an increased infiltration of non-contractile tissue (collagen, fat). Accentuated by cancer and treatments, sarcopenia impairs muscle function resulting in a higher risk of physical disability and death. The commonly used test for sarcopenia screening consists in a DEXA (Dual energy X-ray absorptiometry) scan. However, this test can't provide structural muscle information. In contrast, the mechanical properties of muscle tissue can be explored using an acoustic radiation force impulse (ARFI). The question remains whether muscle sonoelastography using ARFI imaging could be helpful for sarcopenia screening. For this, volunteers will be recruited in three groups: ≤ 30 years (Gr A) and ≥ 70years, both without any serious chronic disease, and patients ≥ 70 years presenting curative cares for cancer (Gr C). The volunteers belonging to the groups A and B will be followed during one day. The patients included in the group C will be followed during 6 months. For this latter group; the first visit (t0) will take place before treatment and the second visit will take place 6 months later (t6months) Volunteers will have clinical examinations (weight, stature, BMI, performance status/ ECOG) and will be evaluated on their nutritional status (MNA-SF, 24h dietary recall) and physical capacities (IPAQ, SPPB, lower limb muscle strength, 6-min walk test, QLQ-C30 items relative to the fatigue symptom).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Sarcopenia, ARFI, DEXA, Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Volunteers (18 -30 years)
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Volunteers (70 years or older)
Arm Title
Arm C
Arm Type
Experimental
Arm Description
70 years patient or older with curative cares for cancer
Intervention Type
Device
Intervention Name(s)
ARFI
Intervention Description
Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging
Primary Outcome Measure Information:
Title
Viscoelasticity of the contracted Tibialis anterior muscle
Description
Describe and compare the distribution curves of viscoelasticity of the contracted Tibialis anterior muscle, measured by the ARFI shear wave velocity, between each group.
Time Frame
Day 1 (group A, B and C) and month 6 (group C only)
Secondary Outcome Measure Information:
Title
Viscoelasticity of the contracted and relaxed Rectus femoris and Soleus muscles
Time Frame
Day 1 (group A, B and C) and month 6 (group C only)
Title
Distribution curves of subcutaneous thickness in relaxed condition between each group on Rectus femoris and Soleus muscles
Time Frame
Day 1 (group A, B and C) and month 6 (group C only)
Title
Compare fort each muscle the distribution curves of pennation angles in relaxed and contracted conditions between each group on Rectus femoris and Soleus muscles
Time Frame
Day 1 (group A, B and C) and month 6 (group C only)
Title
Evaluate the influence of physical and/or nutritional status, age, and cancer pathology
Time Frame
Day 1 (group A, B and C) and month 6 (group C only)
Title
Evaluate the intra-operator reproducibility
Time Frame
Day 1 (group A, B and C)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Men or women 18 years old or more, Able to understand the protocol and to give their written consent, Health insurance. Specific inclusion criteria: Group A: volunteers 18 to 30 yrs; without any pathology, Group B: volunteers ≥ 70 yrs; without any pathology, Group C: Performance status (ECOG) < 4; patients included in CAPADOGE study presenting curative cares for cancer by chemotherapy and/ or surgery and/or hormonotherapy and/or radiotherapy. Exclusion Criteria: Intense activity in 7 preceding days, Functional dependency, under a legal protection. Specific non-inclusion criteria: Groups A & B: serious chronic disease, Group C: Palliative care.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nora FRULIO, Dr
Organizational Affiliation
University Hospital, Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux - Hôpital Saint André
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU de Bordeaux - Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33600
Country
France

12. IPD Sharing Statement

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Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer

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