Clinical trials will improve treatment and follow-up

October 22, 2013 by Elin Fugelsnes & Else Lie, The Research Council of Norway
Clinical trials will improve treatment and follow-up
Exercise training and pulmonary rehabilitation are recommended for COPD patients at all stages of the disease, says Paolo Zanaboni. Credit: NST

Three major clinical trials will help to develop and target treatment and follow-up of patients suffering from COPD, lung cancer and rheumatoid arthritis in Norway.

"Randomised are the best method of obtaining required documentation of the effect, safety and cost-efficacy of various methods or types of treatment employed by the health services," says Kåre Birger Haugen, chair of the programme board of the Research Council of Norway's Programme on Clinical Research (KLINISKFORSKNING), which has provided funding to the studies.

Will follow up COPD patients at home

At the Norwegian Centre for Integrated Care and Telemedicine in Tromsø in Northern Norway, researchers will be studying the effect of telemedicine on people suffering from chronic obstructive pulmonary disease (COPD). Telemedicine involves treatment and monitoring activities for independent of the location of the medical expertise.

"Exercise training and pulmonary rehabilitation are recommended for COPD patients at all stages of the disease. Since we can't offer all patients pulmonary rehabilitation in an institution, we are working to develop a low-intensity telerehabilitation service for patients in their own homes," explains project manager Paolo Zanaboni.

Roughly 120 patients in Norway, Denmark and Australia will be divided into one intervention group and two control groups.

The patients in the intervention group will be given a treadmill and a device that measures their oxygen saturation and pulse rate. They will receive regular follow-up from a physiotherapist via a videoconferencing system on an iPad. The physiotherapist can adjust the exercise training programme based on measurements patients enter on a website after each training session.

The patients in one of the control groups will receive standard COPD treatment, while the patients in the other control group will be given equipment for at-home with no telemedical follow-up.

"It's important to find out whether it is the exercise on its own or the exercise in conjunction with telemedicine that is most effective," says Dr Zanaboni.

Longer life for lung cancer patients?

A new cancer study will explore whether a new therapy principle can extend the lives of patients with lung cancer with metastasis. Lung cancer is the second-most common form of cancer for both men and women in Norway, and the one with the highest mortality rate.

Some 85 per cent of the 3 000 individuals diagnosed with lung cancer each year have non-small-cell . Patients with advanced metastasised cancer have a survival rate of between seven and 14 months. Normal treatment today consists of four courses of chemotherapy. Patients may be given more chemotherapy when the cancer gets worse.

"Instead of watching and waiting after the four standard courses of chemotherapy, we will be studying the effect of immediate pemetrexed maintenance therapy. Earlier studies have shown that this can prolong survival by three to five months, or 40–50 per cent," says project manager Bjørn Grønberg, who is a consultant in oncology at the Cancer Clinic at St. Olavs Hospital in Trondheim.

"No other studies on this patient group have even hinted at a similar improvement in survival rate," Dr Grønberg points out.

Approximately 25 Norwegian hospitals will be participating in the clinical trial, which will involve 700 patients over a two-and-a-half-year period.

Can rheumatoid arthritis patients stay healthy without biologics?

"In the past 10–15 years, new biologic drugs for rheumatoid arthritis have emerged that have shown excellent results when used with modern treatment strategies. Nine of 10 patients with recently diagnosed rheumatoid arthritis treated according to these principles will cease to exhibit signs or symptoms of active disease", explains project manager Espen A. Haavardsholm at Diakonhjemmet Hospital in Oslo.

The downside is that biologics are costly, and suppress the immune system to an extent that increases the risk of infection. Now the researchers are looking to see if it is possible to discontinue the drugs and still keep patients symptom-free.

One group of patients will gradually taper off and withdraw from biologics, continuing standard treatment with older types of drugs. Another group will continue taking biologics.

"Perhaps the study will reveal that some patients should continue taking biologics, while others should stop. We will be looking for predictors that can indicate this at an early stage," says Dr Haavardsholm.

The clinical trial will involve 320 patients throughout Norway.

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