At the NCI Cancer Hospital
New frontiers in cancer treatment, Sept 27 at The New Straits Times; http://www.nst.com.my/
Debra Chong
What happens when standard cancer treatment methods fail? DEBRA CHONG talks to a patient and her doctors about progress made in a cancer clinical trial.
MADAM Tum Kum Pheng has been battling breast cancer for the past 10 years. In fact, her disease is currently at such an advanced stage, she no longer responds to standard treatments like chemotherapy or radiotherapy.
Yet the petite 60-year old does not fit one’s imagination of what a cancer patient looks like. She has a full head of hair, cut short to frame a carefully made-up face. Her shy smile, which appears frequently — perhaps out of nervousness — animates her features.
Tum is one of two participants in a cancer clinical trial currently underway at the NCI Cancer Hospital (NCICH) in Nilai, Negri Sembilan, the country’s first stand-alone private specialist centre in cancer treatment and research.
The Seremban native, a housewife and mother of three, first discovered a lump on her right breast 10 years ago.
She knew right away that it was cancer. Her mother had died from bone cancer, and her uncle, from lung cancer. She was sure she too had cancer; and that she was going to die from it. Everyone had told her so. Ignorance and lack of access to proper advice kept her from seeking medical treatment then.
"Since I was dying, why waste money? Better to keep it for the children’s education," said Tum through an interpreter during a routine check-up at the hospital, where she has been receiving treatment since last September.
She told her husband and he agreed not to tell their three schooling children to keep them from worrying.
Until one day last year. Her tumour ruptured and Tum started bleeding profusely. Her children rushed her to a private hospital in town and learnt their mother’s secret.
The hospital there did not have the facilities to treat her critical state. The doctors recommended the nearby NCICH, where she immediately underwent radiotherapy to stop the haemorrhage.
After the radiotherapy, she was put on chemotherapy, but she failed to respond positively to both standard cancer treatment methods. At that point, water started to accumulate in her lungs. The tumour had spread from one breast to the other. She felt pain in her legs. Her arms were swollen and discoloured. She couldn’t even lift her hand — the muscles had hardened.
That was when her attending doctor, Dr. R. Kananathan, a consultant physician and medical oncologist at NCICH, suggested she participate in a cancer clinical trial he and another doctor were conducting at the hospital.
Dr Kana, as he is more commonly called, is involved in several clinical studies at NCICH. One of them examines the effectiveness of a new type of anti-cancer drug at the third phase of its clinical trial, headed by Dr G. Selvaratnam.
Kana gave Tum a week to discuss the option with her family. Her reply, however, was instant. She agreed to participate. Her husband convinced her that it was her only recourse to prolong her life.
Still, medical protocol insists that Tum understood the full extent of the clinical trial: how it is conducted, what are the benefits and what the risks, and what her rights are as a participant. After she signed the informed consent, Tum’s trial began.
Today, Tum’s condition has stabilised. Before the trial, her tumour was an 11cm mass. Now, it measures 6cm. Every six weeks, she goes back to the hospital to have her body scanned. She is now in her fifth month of treatment.
According to Kana, Tum has undergone five cycles of therapy. Each cycle lasts three weeks and costs RM3,000.
"She has tolerated therapy well, apart from numbness. She has stage four cancer. There are less than five people who are still living within one year (with cancer at that stage). She has surpassed one year," revealed Kana, when asked about the side-effects on Tum.
Tum herself describes how she finds it easier to breathe now. She can now lift her arm and walk on her own. She doesn’t get so many dizzy spells. She doesn’t feel tired all the time as she did before the trial.
Does she regret not visiting the doctor earlier?
She thought for a moment, then said: "Cancer is nothing to fear. Face it. The earlier you get it treated, the better your prognosis".
Clearly, Tum is not concerned about looking back. Her concern is to tell everyone her story, that they may learn from it. She understands that the clinical trial is no guarantee for an extended lease on life. She knows death could come any time, but she doesn’t fear it.
"(For me) every day is a bonus," says Tum, smiling.
10 things to know about cancer clinical trials
1. What is a clinical trial?
Cancer clinical trials are research studies that test how well a new approach works to screen, prevent, diagnose and treat the disease in humans.
2. What kinds of clinical trials are there?
A clinical trial is only ONE of the stages in a long and careful research process. There are two types of clinical trials, oncological and non-oncological. These can be separated into various categories:
Prevention trials; Screening trials; Diagnostic trials; Treatment trials;Supportive care/quality of life; Genetics studies
3. How is a clinical trial planned?
The trial is designed to show how a certain anti-cancer strategy — for example, a new drug or a new diagnostic method — affects the recipient.
4. How is it carried out?
Many treatment trials are a comparison between a new treatment and a standard treatment. Participants are randomly selected by a computer system and separated into two groups to ensure fair and objective scientific results.
5. How can clinical trials benefit cancer patients?
Participants will be among the first to benefit if the new approach is proven to work. While undergoing the trial, cancer patients are given access to promising new treatments that are not available outside of the clinical trail setting. They receive quality care treatment such as closely-monitored follow-ups to their condition.
6. Are there risks?
On the downside, the new treatment under study may not be better or as good as standard care and may have unexpected side effects. Participants also do not get to choose the type of treatment to be given.
7. How does one participate
Not every cancer patient can participate in a clinical trial. There are different guidelines, depending on the type of research study. Generally, the key factors that influence eligibility are the type and stage of cancer, age, gender of the patient. Usually, the doctors will make the recommendation if they think the patient meets the criteria.
8. What is informed consent
Before a patient can take part in a clinical trial, he or she is fully educated about the study’s treatments and tests, the benefits and possible side-effects. This process is called the informed consent and is the most important step before any trial begins. Among others, the patient is informed of the right to terminate participation at any point during the clinical trial.
9. Who pays for the costs?
The research costs of a clinical trial is covered by the study sponsor, often a pharmaceutical manufacturer. However, patient care costs in a study varies according to the individual programme. A patient should always ask the attending doctor or nurse about what costs are covered and what aren’t before agreeing to participate.
10. Where do clinical trials take place?
Cancer trials take place all over the world. In Malaysia, the trials are carried out by the Ministry of Health in selected general hospitals, private hospitals like NCI Cancer Hospital in Negri Sembilan, Gleneagles CRC in Penang and university bodies such as the University of Malaya, University Kebangsaan Malaysia and Universiti Sains Malaysia.
A brief history
CLINICAL trials have had unsavoury associations at certain periods in history. Some may recall the horrors of forced Nazi scientific experiments on prisoners-of-war at Nuremberg in World War 2.
The Declaration of Helsinki in 1964 (revised in 1975) produced the principle of ethics that have become the global standard in clinical research today that ensures no participant is forced into a research against his/her will.
In 1996, the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for human use established a unified code of ethical and scientific quality for clinical trials in European Union, Japan and the United States. In other words, it organised a uniform set of global guidelines that made Good Clinical Practice (GCP).
The ICH GCP provides assurance that the rights, safety and well-being of participants in any clinical research are protected and the data are internationally credible. Due to this practice, the process of marketing new drugs is speeded up for the benefit of mankind.
In Malaysia, organised clinical trials took off big in the late 1990s under the leadership of Datuk Dr Ismail Merican, the director-general of the Ministry of Health.
He laid down the groundwork for government-initiated clinical research, said Dr R. Kananathan, a consultant physician and medical oncologist at a private cancer specialist hospital in Negri Sembilan.
Among the public hospitals where cancer trials are conducted are Hospital Kuala Lumpur, the Selayang Hospital in Selangor and the Sarawak General Hospital.
In November 1999, the Ministry of Health established the Malaysian Good Clinical Practice Guidelines, a landmark document that contained certain modifications for local practice while still adhering to the basic principles of the ICH GCP.
Said Kananathan: "In a dreaded situation like cancer, people panic. And that is a shame. There are a lot of trials going around in the country, especially in university hospitals. People should talk about them."
Note by blogger: Information about NCI can be obtained at www.nci.com.my
Debra Chong
What happens when standard cancer treatment methods fail? DEBRA CHONG talks to a patient and her doctors about progress made in a cancer clinical trial.
MADAM Tum Kum Pheng has been battling breast cancer for the past 10 years. In fact, her disease is currently at such an advanced stage, she no longer responds to standard treatments like chemotherapy or radiotherapy.
Yet the petite 60-year old does not fit one’s imagination of what a cancer patient looks like. She has a full head of hair, cut short to frame a carefully made-up face. Her shy smile, which appears frequently — perhaps out of nervousness — animates her features.
Tum is one of two participants in a cancer clinical trial currently underway at the NCI Cancer Hospital (NCICH) in Nilai, Negri Sembilan, the country’s first stand-alone private specialist centre in cancer treatment and research.
The Seremban native, a housewife and mother of three, first discovered a lump on her right breast 10 years ago.
She knew right away that it was cancer. Her mother had died from bone cancer, and her uncle, from lung cancer. She was sure she too had cancer; and that she was going to die from it. Everyone had told her so. Ignorance and lack of access to proper advice kept her from seeking medical treatment then.
"Since I was dying, why waste money? Better to keep it for the children’s education," said Tum through an interpreter during a routine check-up at the hospital, where she has been receiving treatment since last September.
She told her husband and he agreed not to tell their three schooling children to keep them from worrying.
Until one day last year. Her tumour ruptured and Tum started bleeding profusely. Her children rushed her to a private hospital in town and learnt their mother’s secret.
The hospital there did not have the facilities to treat her critical state. The doctors recommended the nearby NCICH, where she immediately underwent radiotherapy to stop the haemorrhage.
After the radiotherapy, she was put on chemotherapy, but she failed to respond positively to both standard cancer treatment methods. At that point, water started to accumulate in her lungs. The tumour had spread from one breast to the other. She felt pain in her legs. Her arms were swollen and discoloured. She couldn’t even lift her hand — the muscles had hardened.
That was when her attending doctor, Dr. R. Kananathan, a consultant physician and medical oncologist at NCICH, suggested she participate in a cancer clinical trial he and another doctor were conducting at the hospital.
Dr Kana, as he is more commonly called, is involved in several clinical studies at NCICH. One of them examines the effectiveness of a new type of anti-cancer drug at the third phase of its clinical trial, headed by Dr G. Selvaratnam.
Kana gave Tum a week to discuss the option with her family. Her reply, however, was instant. She agreed to participate. Her husband convinced her that it was her only recourse to prolong her life.
Still, medical protocol insists that Tum understood the full extent of the clinical trial: how it is conducted, what are the benefits and what the risks, and what her rights are as a participant. After she signed the informed consent, Tum’s trial began.
Today, Tum’s condition has stabilised. Before the trial, her tumour was an 11cm mass. Now, it measures 6cm. Every six weeks, she goes back to the hospital to have her body scanned. She is now in her fifth month of treatment.
According to Kana, Tum has undergone five cycles of therapy. Each cycle lasts three weeks and costs RM3,000.
"She has tolerated therapy well, apart from numbness. She has stage four cancer. There are less than five people who are still living within one year (with cancer at that stage). She has surpassed one year," revealed Kana, when asked about the side-effects on Tum.
Tum herself describes how she finds it easier to breathe now. She can now lift her arm and walk on her own. She doesn’t get so many dizzy spells. She doesn’t feel tired all the time as she did before the trial.
Does she regret not visiting the doctor earlier?
She thought for a moment, then said: "Cancer is nothing to fear. Face it. The earlier you get it treated, the better your prognosis".
Clearly, Tum is not concerned about looking back. Her concern is to tell everyone her story, that they may learn from it. She understands that the clinical trial is no guarantee for an extended lease on life. She knows death could come any time, but she doesn’t fear it.
"(For me) every day is a bonus," says Tum, smiling.
10 things to know about cancer clinical trials
1. What is a clinical trial?
Cancer clinical trials are research studies that test how well a new approach works to screen, prevent, diagnose and treat the disease in humans.
2. What kinds of clinical trials are there?
A clinical trial is only ONE of the stages in a long and careful research process. There are two types of clinical trials, oncological and non-oncological. These can be separated into various categories:
Prevention trials; Screening trials; Diagnostic trials; Treatment trials;Supportive care/quality of life; Genetics studies
3. How is a clinical trial planned?
The trial is designed to show how a certain anti-cancer strategy — for example, a new drug or a new diagnostic method — affects the recipient.
4. How is it carried out?
Many treatment trials are a comparison between a new treatment and a standard treatment. Participants are randomly selected by a computer system and separated into two groups to ensure fair and objective scientific results.
5. How can clinical trials benefit cancer patients?
Participants will be among the first to benefit if the new approach is proven to work. While undergoing the trial, cancer patients are given access to promising new treatments that are not available outside of the clinical trail setting. They receive quality care treatment such as closely-monitored follow-ups to their condition.
6. Are there risks?
On the downside, the new treatment under study may not be better or as good as standard care and may have unexpected side effects. Participants also do not get to choose the type of treatment to be given.
7. How does one participate
Not every cancer patient can participate in a clinical trial. There are different guidelines, depending on the type of research study. Generally, the key factors that influence eligibility are the type and stage of cancer, age, gender of the patient. Usually, the doctors will make the recommendation if they think the patient meets the criteria.
8. What is informed consent
Before a patient can take part in a clinical trial, he or she is fully educated about the study’s treatments and tests, the benefits and possible side-effects. This process is called the informed consent and is the most important step before any trial begins. Among others, the patient is informed of the right to terminate participation at any point during the clinical trial.
9. Who pays for the costs?
The research costs of a clinical trial is covered by the study sponsor, often a pharmaceutical manufacturer. However, patient care costs in a study varies according to the individual programme. A patient should always ask the attending doctor or nurse about what costs are covered and what aren’t before agreeing to participate.
10. Where do clinical trials take place?
Cancer trials take place all over the world. In Malaysia, the trials are carried out by the Ministry of Health in selected general hospitals, private hospitals like NCI Cancer Hospital in Negri Sembilan, Gleneagles CRC in Penang and university bodies such as the University of Malaya, University Kebangsaan Malaysia and Universiti Sains Malaysia.
A brief history
CLINICAL trials have had unsavoury associations at certain periods in history. Some may recall the horrors of forced Nazi scientific experiments on prisoners-of-war at Nuremberg in World War 2.
The Declaration of Helsinki in 1964 (revised in 1975) produced the principle of ethics that have become the global standard in clinical research today that ensures no participant is forced into a research against his/her will.
In 1996, the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for human use established a unified code of ethical and scientific quality for clinical trials in European Union, Japan and the United States. In other words, it organised a uniform set of global guidelines that made Good Clinical Practice (GCP).
The ICH GCP provides assurance that the rights, safety and well-being of participants in any clinical research are protected and the data are internationally credible. Due to this practice, the process of marketing new drugs is speeded up for the benefit of mankind.
In Malaysia, organised clinical trials took off big in the late 1990s under the leadership of Datuk Dr Ismail Merican, the director-general of the Ministry of Health.
He laid down the groundwork for government-initiated clinical research, said Dr R. Kananathan, a consultant physician and medical oncologist at a private cancer specialist hospital in Negri Sembilan.
Among the public hospitals where cancer trials are conducted are Hospital Kuala Lumpur, the Selayang Hospital in Selangor and the Sarawak General Hospital.
In November 1999, the Ministry of Health established the Malaysian Good Clinical Practice Guidelines, a landmark document that contained certain modifications for local practice while still adhering to the basic principles of the ICH GCP.
Said Kananathan: "In a dreaded situation like cancer, people panic. And that is a shame. There are a lot of trials going around in the country, especially in university hospitals. People should talk about them."
Note by blogger: Information about NCI can be obtained at www.nci.com.my
posted by Hee Boon at 5:46 pm
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