Ignite Creation Date:
2024-05-06 @ 3:58 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02412683
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2015-01-16
Brief Title:
Neurotoxic Symptoms in Adjuvant Chemotherapy in Patients With Colorectal Cancer
Sponsor:
Jenny Drott
Organization:
Linkoeping University
Study Overview
Official Title:
Neurotoxic Symptoms in Adjuvant Chemotherapy in Patients With Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subgroups of patients with radically operated colorectal cancer can have a better prognosis by over six months are treated with chemotherapy This beneficial effect may be enhanced somewhat by providing a combination of chemotherapy and the addition of oxaliplatin It is known that this treatment additions increase the risk of neurotoxic side effects such as sensitivity to cold numbness and tingling in hands or feet muscle cramps pain taste disorders and swallowing difficulties
The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant chemotherapy experience neurotoxic effects and if the experience of the symptoms change over time during treatment and how symptoms affect patients daily lives and quality of life
The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant chemotherapy experience neurotoxic effects and if the experience of the symptoms change over time during treatment and how symptoms affect patients daily lives and quality of life
Detailed Description:
Subgroups of patients with radically operated colorectal cancer can have a better prognosis by over six months are treated with chemotherapy This beneficial effect may be enhanced somewhat by providing a combination of chemotherapy and the addition of oxaliplatin It is known that this treatment additions increase the risk of neurotoxic side effects such as sensitivity to cold numbness and tingling in hands or feet muscle cramps pain taste disorders and swallowing difficulties A few studies on patients experience of the neurotoxic symptoms and its impact on daily life
The operative treatment of colorectal cancer is surgery The possibility of curative resection is the factor most strongly associated to the patients survival High-risk patients and metastasis is not a contraindication for surgery of the primary tumor but the individual patients benefit from surgery must be especially valued If the primary tumor does not cause any troublesome symptoms and there are metastases in other organs which can be treated with non-surgical methods the tumor can be left initially and removed later if symptoms occur For rectal cancer radiation therapy can be topical and reduces the risk of local recurrence In locally advanced cancer in which radical resection is not possible radiation therapy with or without chemotherapy be current in order to achieve tumor-killing effect of the infiltration zone Radiation therapy can cause acute and chronic complications such as pain faecal incontinence and sexual dysfunction which may affect patients quality of life
At more advanced but radically operated colorectal cancer is commonly advised chemotherapy The goal of giving chemotherapy is that if possible prevent micrometastasis that may exist in any patient even though the patient is managed with radical surgery Colorectal cancer spreads primarily to the lymph nodes and liver but also through the bloodstream to the lungs brain and bone Choice of chemotherapy is influenced by several factors including tumor extent time from primary diagnosis previous treatment given symptoms performance status concomitant other diseases blood tests and patients own attitude towards such readiness to accept some side effects Treatment intention can be curative palliative or prophylactic adjuvant There are mainly three types of chemotherapy used to treat colorectal cancers They can be individual but is usually provided in combination They can be given in multiple lines which means that a combination can be administered initially and then changed to another combination of poor tolerance or treatment failure Most patients get two or three lines of treatment
Intended to provide combination therapy is to increase efficacy against the tumor reducing the risk of resistance developing and spreading side effects The effect of a particular treatment is best the earlier it is given but may be meaningful even at a later stage A cornerstone of treatment for over five decades 5-fluorouracil 5FU which in colorectal cancer in combination with folinic acid leucovorin This regime is relatively lowtoxic and most patients are capable of treatment without severe side effects Capecitabine Xeloda is another treatment regimen which is often preferred by patients because it is given orally and usually mild side effects Another treatment option is to give oxaliplatin in addition to 5-flurouracil leucovorin or capecitabine FOLFOX 4 PHLOX XELOX These combinations are under trials to prolong survival compared with only 5-flurouracil and leucovorin Oxaliplatin can reduce the risk of relapse by about 25 percent in comparison with 5FUleukovorin This regimen poses an increased proportion of neurotoxic side effects as a result Chemotherapy can generally provide a number of unpleasant and sometimes life-threatening side effects Side effects that may occur are symptoms of nausea vomiting diarrhea anemia skin lesions and mouth blown
This can result in nutritional difficulties reduced strength and impaired immune system with increased risk of infection
The fact that the patient be informed of a cancer diagnosis is a strain on both the patient but also for the relatives This may mean that ordinary life is changing and that the normal daily activities can not be performed previously because of hospitalization surgical and oncological treatment As far as quality of life as it includes the experience of health and welfare of the patient based on physical psychological and social needs It may also include economic political and spiritual needs The concept of health-related quality of life suited to the context in which disease symptoms affect the individuals physical function Possible treatments and its side effects can affect individuals ability to function Health-related quality of life is an individual experience and can vary between individuals In the case of the most valuable views on the treatment results so the patient has a very important role Patients who have a disease with a reading experience both advantages and disadvantages side effects with their treatment By measuring the patients health-related quality of life it is possible to create a picture of the patients perspective on their illness and treatment
Sense Of Coherence SOC has been by Antonovsky divided into three key components comprehensibility manageability and meaningfulness Antonovsky argues that the degree of SOC affects a persons ability to handle stressful situations Studies show that psychological stress has a negative impact on quality of life in patients with various types of cancer but few studies have shown that the same applies to colorectal cancer patients But the cancer patients personality affects the perceived quality of life is known Several psychological and personality factors play a central role in the disease process A strong sense of coherence is a health-stimulating factor and in studies of cancer patients resulted in reduced mortality disease progression and resignation The cancer involves the patient an extensive psychological stressful situation and the patients capacity to adapt themselves to be influenced by his defense The validated instrument SOC Sense of Coherence is able to measure the patients sense of coherence
Neurotoxic side effects often occur during treatment with oxaliplatin Oxaliplatin can cause acute and delayed neuropathies Studies have shown that some patients have persistent and chronic problems Acute neurotoxicity is usually a half hour to an hour after start of infusion and disappears after a few days and often arrives at any doses These symptoms can present themselves as paresthesia cold intolerance and pain in the eye and jaw abdominal pain cramps in legs and calves numbness and tingling of the hands feet and around his mouth and voice and vision changes Side effects are not reduced within 14 days can be permanent nerve damage leading to difficulties to write walk swallow and carry out daily activities Permanent damage may occur without acute side effects initial stage It is important that especially during the second half of the treatment period observe signs of neurotoxic symptoms consisting of therapy Studies show that the neurotoxic effects greatly affected how long the treatment lasted If patients have these side effects should oxaliplatin reduced or excluded for fear debilitating and prolonged neuropathy
The drug-specific questionnaire Oxaliplatin-Specific Neurotoxicity Scale is the most accurate instrument for measuring the neurotoxic symptoms The instrument is divided into three parts upper extremities lower extremities and mouth facial region Symptoms estimated from the preceding cycle of therapy and graded based on whether symptoms exist or not If the patient has symptoms these should be graded from 1-5 Patients should also rate the extent to which symptoms affect their daily lives and activities between 1-5
It is important to note early neurotoxic effects and to encourage patients to report symptoms that arise Information before treatment is started if the side effects that might arise and how patients can detect early symptoms are significant
Patients who had neuropathy in the upper extremities experienced difficulties such as fastening buttons zips close write sew and do housework unlike the patients with lower neuropathy who had difficulty driving walking train and carry out activities balance The perceived disability can cause feelings of anxiety depression frustration anger and difficulty in adapting to their situation which may also affect the social interaction
The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant chemotherapy experience neurotoxic effects and if the experience of the symptoms change over time during treatment and how symptoms affect patients daily lives and quality of life
The operative treatment of colorectal cancer is surgery The possibility of curative resection is the factor most strongly associated to the patients survival High-risk patients and metastasis is not a contraindication for surgery of the primary tumor but the individual patients benefit from surgery must be especially valued If the primary tumor does not cause any troublesome symptoms and there are metastases in other organs which can be treated with non-surgical methods the tumor can be left initially and removed later if symptoms occur For rectal cancer radiation therapy can be topical and reduces the risk of local recurrence In locally advanced cancer in which radical resection is not possible radiation therapy with or without chemotherapy be current in order to achieve tumor-killing effect of the infiltration zone Radiation therapy can cause acute and chronic complications such as pain faecal incontinence and sexual dysfunction which may affect patients quality of life
At more advanced but radically operated colorectal cancer is commonly advised chemotherapy The goal of giving chemotherapy is that if possible prevent micrometastasis that may exist in any patient even though the patient is managed with radical surgery Colorectal cancer spreads primarily to the lymph nodes and liver but also through the bloodstream to the lungs brain and bone Choice of chemotherapy is influenced by several factors including tumor extent time from primary diagnosis previous treatment given symptoms performance status concomitant other diseases blood tests and patients own attitude towards such readiness to accept some side effects Treatment intention can be curative palliative or prophylactic adjuvant There are mainly three types of chemotherapy used to treat colorectal cancers They can be individual but is usually provided in combination They can be given in multiple lines which means that a combination can be administered initially and then changed to another combination of poor tolerance or treatment failure Most patients get two or three lines of treatment
Intended to provide combination therapy is to increase efficacy against the tumor reducing the risk of resistance developing and spreading side effects The effect of a particular treatment is best the earlier it is given but may be meaningful even at a later stage A cornerstone of treatment for over five decades 5-fluorouracil 5FU which in colorectal cancer in combination with folinic acid leucovorin This regime is relatively lowtoxic and most patients are capable of treatment without severe side effects Capecitabine Xeloda is another treatment regimen which is often preferred by patients because it is given orally and usually mild side effects Another treatment option is to give oxaliplatin in addition to 5-flurouracil leucovorin or capecitabine FOLFOX 4 PHLOX XELOX These combinations are under trials to prolong survival compared with only 5-flurouracil and leucovorin Oxaliplatin can reduce the risk of relapse by about 25 percent in comparison with 5FUleukovorin This regimen poses an increased proportion of neurotoxic side effects as a result Chemotherapy can generally provide a number of unpleasant and sometimes life-threatening side effects Side effects that may occur are symptoms of nausea vomiting diarrhea anemia skin lesions and mouth blown
This can result in nutritional difficulties reduced strength and impaired immune system with increased risk of infection
The fact that the patient be informed of a cancer diagnosis is a strain on both the patient but also for the relatives This may mean that ordinary life is changing and that the normal daily activities can not be performed previously because of hospitalization surgical and oncological treatment As far as quality of life as it includes the experience of health and welfare of the patient based on physical psychological and social needs It may also include economic political and spiritual needs The concept of health-related quality of life suited to the context in which disease symptoms affect the individuals physical function Possible treatments and its side effects can affect individuals ability to function Health-related quality of life is an individual experience and can vary between individuals In the case of the most valuable views on the treatment results so the patient has a very important role Patients who have a disease with a reading experience both advantages and disadvantages side effects with their treatment By measuring the patients health-related quality of life it is possible to create a picture of the patients perspective on their illness and treatment
Sense Of Coherence SOC has been by Antonovsky divided into three key components comprehensibility manageability and meaningfulness Antonovsky argues that the degree of SOC affects a persons ability to handle stressful situations Studies show that psychological stress has a negative impact on quality of life in patients with various types of cancer but few studies have shown that the same applies to colorectal cancer patients But the cancer patients personality affects the perceived quality of life is known Several psychological and personality factors play a central role in the disease process A strong sense of coherence is a health-stimulating factor and in studies of cancer patients resulted in reduced mortality disease progression and resignation The cancer involves the patient an extensive psychological stressful situation and the patients capacity to adapt themselves to be influenced by his defense The validated instrument SOC Sense of Coherence is able to measure the patients sense of coherence
Neurotoxic side effects often occur during treatment with oxaliplatin Oxaliplatin can cause acute and delayed neuropathies Studies have shown that some patients have persistent and chronic problems Acute neurotoxicity is usually a half hour to an hour after start of infusion and disappears after a few days and often arrives at any doses These symptoms can present themselves as paresthesia cold intolerance and pain in the eye and jaw abdominal pain cramps in legs and calves numbness and tingling of the hands feet and around his mouth and voice and vision changes Side effects are not reduced within 14 days can be permanent nerve damage leading to difficulties to write walk swallow and carry out daily activities Permanent damage may occur without acute side effects initial stage It is important that especially during the second half of the treatment period observe signs of neurotoxic symptoms consisting of therapy Studies show that the neurotoxic effects greatly affected how long the treatment lasted If patients have these side effects should oxaliplatin reduced or excluded for fear debilitating and prolonged neuropathy
The drug-specific questionnaire Oxaliplatin-Specific Neurotoxicity Scale is the most accurate instrument for measuring the neurotoxic symptoms The instrument is divided into three parts upper extremities lower extremities and mouth facial region Symptoms estimated from the preceding cycle of therapy and graded based on whether symptoms exist or not If the patient has symptoms these should be graded from 1-5 Patients should also rate the extent to which symptoms affect their daily lives and activities between 1-5
It is important to note early neurotoxic effects and to encourage patients to report symptoms that arise Information before treatment is started if the side effects that might arise and how patients can detect early symptoms are significant
Patients who had neuropathy in the upper extremities experienced difficulties such as fastening buttons zips close write sew and do housework unlike the patients with lower neuropathy who had difficulty driving walking train and carry out activities balance The perceived disability can cause feelings of anxiety depression frustration anger and difficulty in adapting to their situation which may also affect the social interaction
The aim is to investigate how colorectal cancer patients with oxaliplatin adjuvant chemotherapy experience neurotoxic effects and if the experience of the symptoms change over time during treatment and how symptoms affect patients daily lives and quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None