This trial is active, not recruiting.

Condition cancer
Sponsor Sykehuset Innlandet HF
Collaborator Oslo University Hospital
Start date January 2013
End date April 2015
Trial size 300 participants
Trial identifier NCT01742442, 2012/104 C, E12224


About 50% of cancer patients are >70 years at diagnosis. Age related somatic and psychiatric problems may influence the course of cancer and its treatment. The present study is a prospective observational study. Age related problems will be assessed by clinical frailty indicators covering areas that are recommended in geriatric oncology. The aim is to describe the frequency of age related problems in a cohort of Norwegian cancer patients > 70 years of age, to investigate the predictive/prognostic impact of these indicators on cancer and treatment related morbidity and mortality, and to investigate the association between clinical frailty indicators, sarcopenia (severe loss of muscle mass) and inflammatory response. Patients are recruited at outpatient cancer services, Innlandet Hospital HF (SI), Oslo University Hospital, and Akershus University Hospital. Estimated sample size is 300 with 30 months inclusion and 2 years follow-up. The study emerges from SI in collaboration with several external national and international centres

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Older cancer patients 70 years or older referred to specialist oncology outpatient clinics

Primary Outcomes

Prevalence of age related problems
time frame: At baseline
Physical decline
time frame: Follow-up

Secondary Outcomes

Hospital and nursing home admittance
time frame: 2-4 months and 2 years follow-up
Quality of life
time frame: 2 - 4 months and 2 years follow-up
Treatment toxicity
time frame: 2-4months and up to 2 years
time frame: 2 years follow-up

Eligibility Criteria

Male or female participants at least 70 years old.

Inclusion Criteria: - age >= 70 years - histologically/cytologically verified cancer disease - referred to specialist oncology service - no former chemotherapy for actual status (new cancer diagnosis no former or chemotherapy for metastatic disease) - subject to medical oncological treatment that may be initiated and administered at the hospital trust the patient is referred to - able to provide written consent - fluent in Norwegian (orally and written) Exclusion Criteria: - lymphomas and haematological malignancies

Additional Information

Official title Cancer in the Elderly: Prevalence and Impact of Age Related Problems. A Prospective Observational Study
Principal investigator Marit S Jordhøy, MD, PhD
Description The proportion of elderly cancer patients is high and is likely to increase due to an increasing cancer incidence and an aging population. The prevalence and impact of age related problems are, however, poorly documented, and elderly patients may therefore be subjects to under-treatment and arbitrary modifications of treatment regimens. In order to improve clinical practice, precise identification of patients with increased vulnerability and risk of adverse outcomes is paramount. In the present study, eligible patients will be identified by referral to oncology services at one of the participating cancer units. After consent, the baseline registrations will be performed including relevant medical and sociodemographic data, and quality of life. Age related problems will be assessed by clinical indicators covering comorbidity, medication, emotional, physical and cognitive function and nutritional status. Muscle mass will be quantified by analyses of diagnostic CT scans and a biobank will be established for the analyses of inflammatory markers. Upon inclusion, the patients' physician will be asked to rate the patients as fit, frail or intermediate according to the physicians' subjective judgement. The patients will be followed with assessments of quality of life, emotional function and nutritional status (self-report), cognitive and physical function (self-report and performance tests), muscle mass (diagnostic CT scans when available) and inflammatory markers (biobank). Follow up data will also include registry data (hospital records, primary health care registries, The Norwegian Patient Registry, The Norwegian Cancer Registry and the Norwegian Cause of Death registry). We will describe the prevalence of age related problems, investigate the relation between clinical frailty indicators, sarcopenia, inflammatory response and the physicians' subjective evaluation of the patients' health status. The predictive/prognostic impact of frailty indicators on the patients' self-reported physical function and quality of life, hospital and nursing home admittance, treatment toxicity and survival will also be investigated
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sykehuset Innlandet HF.