Clinical trial NCT01484821: Assessment of in Vivo Skeletal Muscle Viscoelasticity (ARFI Imaging) With Aging and Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
ARFI
DEXA
Cancer
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).


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.

Primary outcomes:
measure: Viscoelasticity of the contracted Tibialis anterior muscle
timeFrame: Day 1 (group A, B and C) and month 6 (group C only)
Secondary outcomes:
measure: Viscoelasticity of the contracted and relaxed Rectus femoris and Soleus muscles
timeFrame: Day 1 (group A, B and C) and month 6 (group C only)
measure: Distribution curves of subcutaneous thickness in relaxed condition between each group on Rectus femoris and Soleus muscles
timeFrame: Day 1 (group A, B and C) and month 6 (group C only)
measure: Compare fort each muscle the distribution curves of pennation angles in relaxed and contracted conditions between each group on Rectus femoris and Soleus muscles
timeFrame: Day 1 (group A, B and C) and month 6 (group C only)
measure: Evaluate the influence of physical and/or nutritional status, age, and cancer pathology
timeFrame: Day 1 (group A, B and C) and month 6 (group C only)
measure: Evaluate the intra-operator reproducibility
timeFrame: Day 1 (group A, B and C)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux - Hôpital Saint André
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital Haut-Lévêque
Study officials:
affiliation: University Hospital, Bordeaux, France
name: Nora FRULIO, Dr
role: PRINCIPAL_INVESTIGATOR
References: