Change of geriatric morbidity and muscle mass of elderly patients with malignant disease after treatment with palliative and adjuvant chemotherapy

Change of geriatric morbidity and muscle mass of elderly patients with malignant disease after treatment with palliative and adjuvant chemotherapy - CHARMING

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41437

Enrollment

450

Registered

2015-05-20

Start date

2015-05-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer-induced muscle loss chemotherapeutic induced muscle wasting

Interventions

Aged (MeSH term)

Chemotherapy

Geriatric assessment

Sarcopenia (MeSH term)

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Patients with malignant disease 2. 65 years of age and older 3. Patients undergoing chemotherapeutic treatment.

Exclusion criteria

Exclusion criteria: 1. Previous systemic chemotherapeutic treatment during the last 3 months.

Design outcomes

Primary

Measure	Time frame
Primary outcome: - Correlation sarcopenia and overall survival Primary study parameter: - Sarcopenia (measured by slice-o-matic using CT-images) Primaire uitkomstmaat:	—

Secondary

Measure	Time frame
Secondary study parameters 1. Geriatric assessment: - Comorbidity and medical history (charlson comorbidity index) - Polypharmacy (5 or more different medicines) - Quality of life (by EORTC QLQ-C30 questionnaire) - Nutritional status (minimal nutritional assessment) - Cognitive disorders (minimal mental state evaluation and clock drawing test) - Physical condition and muscle power (short physical performance battery, steep ramp test, hand grip strength, gait speed) - Mood (geriatric depression scale) - (Instrumental) Activities of Daily life (Lawton and Brody index, Barthel index) 2. Treatment success Unsuccessful completion of chemotherapeutic treatment is concluded in the presence of one of the following events: 1. Dose reduction 2. Delay of chemotherapeutic cycle 3. Cancellation of treatment because of any reason, except disease progression. 3. Biological markers: 1. Serum, inflammatory markers (CRP, interleukins) 2. Isolated DNA and single nucleotide polymorphisms in a biopsy of the skin.	—

Measure

Time frame

Secondary study parameters 1. Geriatric assessment: - Comorbidity and medical history (charlson comorbidity index) - Polypharmacy (5 or more different medicines) - Quality of life (by EORTC QLQ-C30 questionnaire) - Nutritional status (minimal nutritional assessment) - Cognitive disorders (minimal mental state evaluation and clock drawing test) - Physical condition and muscle power (short physical performance battery, steep ramp test, hand grip strength, gait speed) - Mood (geriatric depression scale) - (Instrumental) Activities of Daily life (Lawton and Brody index, Barthel index) 2. Treatment success Unsuccessful completion of chemotherapeutic treatment is concluded in the presence of one of the following events: 1. Dose reduction 2. Delay of chemotherapeutic cycle 3. Cancellation of treatment because of any reason, except disease progression. 3. Biological markers: 1. Serum, inflammatory markers (CRP, interleukins) 2. Isolated DNA and single nucleotide polymorphisms in a biopsy of the skin.

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)