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

Sarcopenia Clinical Trial

— CAPARFI  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484821
• Other study ID #: CHUBX 2011/29
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: January 12, 2015
• Start date: November 2011
• Est. completion date: October 2014

Study information

• Verified date: January 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Device:
• ARFI
Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging

Locations

Country	Name	City	State
France	CHU Bordeaux - Hôpital Saint André	Bordeaux
France	CHU de Bordeaux - Hôpital Haut-Lévêque	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 (group A, B and C) and month 6 (group C only)	No
Secondary	Viscoelasticity of the contracted and relaxed Rectus femoris and Soleus muscles		Day 1 (group A, B and C) and month 6 (group C only)	No
Secondary	Distribution curves of subcutaneous thickness in relaxed condition between each group on Rectus femoris and Soleus muscles		Day 1 (group A, B and C) and month 6 (group C only)	No
Secondary	Compare fort each muscle the distribution curves of pennation angles in relaxed and contracted conditions between each group on Rectus femoris and Soleus muscles		Day 1 (group A, B and C) and month 6 (group C only)	No
Secondary	Evaluate the influence of physical and/or nutritional status, age, and cancer pathology		Day 1 (group A, B and C) and month 6 (group C only)	No
Secondary	Evaluate the intra-operator reproducibility		Day 1 (group A, B and C)	No