JUMPresearchII: Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06007794
Collaborator
(none)
500
1
1
110
4.5

Study Details

Study Description

Brief Summary

Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. One of the major challenges is the detection and management of treatment side effects for all patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. After the evaluation day, patients are referred to the most appropriate structures (Adapted physical activity, sports for health, and rehabilitation at Henry Gabriel Hospital).

JUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). This leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. Finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers.

This non-interventional research is classified as "research involving human subjects", class 3 .

The objective of this research is to evaluate the impact of cancer on the musculoskeletal system and to test ultrasound as a clinical examination for the detection of sarcopenia in this population.

Condition or Disease Intervention/Treatment Phase
  • Other: JUMP group
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Correlation Between Ultrasound-assessed Quadriceps Muscle Mass and Baseline Whole-body Densitometry Muscle Index in the Post-cancer Population (JUMP Research II)
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2032
Anticipated Study Completion Date :
Dec 1, 2032

Arms and Interventions

Arm Intervention/Treatment
Experimental: JUMP group

This study concerns adults with cancer treated with chemotherapy, radiotherapy, hormonal therapy or immunotherapy, in remission or cured. Patients took part in the dedicated post-cancer assessment day. In addition, an ultrasound of the thigh is performed to measure the size of the quadriceps on 5 different measurements.

Other: JUMP group
patients will have a femoral ultrasound and blood tubes in addition to the blood sample taken as part of the treatment

Outcome Measures

Primary Outcome Measures

  1. Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA [through study completion, an average of 9 years]

    Analyze the correlation between muscle mass (thickness) of the quadriceps (rectus femoris) assessed in axial sections by ultrasound and the reference muscle mass index (Appendicular Lean Mass (ALM)/height²) assessed by DEXA Mean thickness of the quadriceps (straight femoris) measured by ultrasound compared to the Appendicular Lean Mass/size² in DEXA

Secondary Outcome Measures

  1. Description of muscle evaluation parameters in the JUMP population compared to the references described [through study completion, an average of 9 years]

    Number of patients with below-average results in reference physical activity tests performed during JUMP dayreferences described : adjustment for age and sex

  2. Quantification of the number of sarcopenic patients in the JUMP population ccording to the definitions of EWGSOP2 [through study completion, an average of 9 years]

    Quantification of the number of sarcopenic patients in the JUMP population according to the definitions of EWGSOP2

  3. Quantification of the number of sarcopenic patients in the JUMP population according to the definitions of BAUMGARTNER [through study completion, an average of 9 years]

    Quantification of the number of sarcopenic patients in the JUMP population according to the definitions of BAUMGARTNER

  4. rate of correlation between fatigue and muscle indices in the JUMP population. [through study completion, an average of 9 years]

    Association between fatigue and muscle indices in the JUMP population.

  5. rate of correlation between the ultrasound muscle index and the scannographic muscle index of the paravertebrals [through study completion, an average of 9 years]

    Correlation between the ultrasound muscle index and the scannographic muscle index of the paravertebrals (SMI L3, T12 and T7)

  6. Rate of correlation between muscle biological markers and the diagnosis of sarcopenia [through study completion, an average of 9 years]

    muscle biological markers are tyrosine, myostatin, FGF19, decarboxylated osteocalcin

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age : 18 to 74 years

  • localization of the primitive: breast, lung, melanoma, testicle, bladder, kidney, ovary, colon and pancreas, hemopathy

  • patient who benefited from the post-cancer assessment day

Exclusion Criteria:
  • Active cancer (relapse or new cancer)

  • Pregnant or breastfeeding women

  • Major cognitive impairment making comprehension and exercise difficult

  • Amputation of both lower limbs (for ultrasound)

  • Difficulty understanding oral and written French

  • Adults under legal protection (guardianship, curatorship or safeguard of justice)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Lyon Sud, rhumatologie Pierre-Bénite France 69495

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT06007794
Other Study ID Numbers:
  • 69HCL23_0368
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 23, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon

Study Results

No Results Posted as of Aug 23, 2023