Colorectal NeoplasmsNCT02412683
Neurotoxic Symptoms in Adjuvant Chemotherapy in Patients With Colorectal Cancer
An observational study of Colorectal Neoplasms, run by Jenny Drott at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- oxaliplatin
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal cancer patients recieved adjuvant oxaliplatin chemotherapy after radical surgery
Who may be able to join
- Colorectal cancer patients recieved adjuvant oxaliplatin chemotherapy after radical surgery
- Ability to answer questions in swedish language
- Ability to answer questions in mobile telephone
Who cannot join
- Colorectal cancer patients in other regimes (palliative setting, no surgery)
- Non ability to answer questions in swedish language
- Non ability to answer questions in mobile telephone
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 patient's survival. High-risk patients and metastasis is not a contraindication for surgery of the primary tumor, but the individual patient's 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 patient's 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 5FU/leukovorin. 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 individual's physical function. Possible treatments and its side effects can affect individual's 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 patient's 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 person's 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 patient's 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- oxaliplatin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxaliplatin-Specific Neurotoxicity Scale
Measured: up to 12 months
Secondary outcomes (2)
Health related quality of life (Fact-G) Questionnaire
Measured: up to 12 months
Sense of Coherence scale (SOC-scale)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2015 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jenny Drott
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jenny Drott, Linkoeping University
- Investigators
- Carina Bertero, RN,professor, Study director, Department of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02412683
- Sponsor's protocol ID
- NTOX-123
- Status last verified
- Sep 2016
- First submitted
- 16 Jan 2015
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Drott J, Fomichov V, Borjeson S, Bertero C. Sense of coherence and health-related quality of life in patients with neurotoxicity after cancer chemotherapy: Assessment from a real-time mobile phone-based system. Psychooncology. 2020 Jan;29(1):107-113. doi: 10.1002/pon.5243. Epub 2019 Oct 31.
PubMed 31670431
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurotoxic Symptoms in Adjuvant Chemotherapy in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02412683
- Acronym / sponsor ID
- NTOX-123
- Conditions
- Colorectal Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jenny DrottOther government
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patient's survival. High-risk patients and metastasis is not a contraindication for surgery of the primary tumor, but the individual patient's 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 patient's 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 5FU/leukovorin. 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 individual's physical function. Possible treatments and its side effects can affect individual's 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 patient's 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 person's 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 patient's 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal cancer patients recieved adjuvant oxaliplatin chemotherapy after radical surgery
Key inclusion criteria (3 listed)
- Colorectal cancer patients recieved adjuvant oxaliplatin chemotherapy after radical surgery
- Ability to answer questions in swedish language
- Ability to answer questions in mobile telephone
Key exclusion criteria (3 listed)
- Colorectal cancer patients in other regimes (palliative setting, no surgery)
- Non ability to answer questions in swedish language
- Non ability to answer questions in mobile telephone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxaliplatin | Other | – |
Primary outcome
Oxaliplatin-Specific Neurotoxicity Scale
Time frame: up to 12 months
2 secondary outcomes
Health related quality of life (Fact-G) Questionnaire
Time frame: up to 12 months
Sense of Coherence scale (SOC-scale)
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 31670431Drott J, Fomichov V, Borjeson S, Bertero C. Sense of coherence and health-related quality of life in patients with neurotoxicity after cancer chemotherapy: Assessment from a real-time mobile phone-based system. Psychooncology. 2020 Jan;29(1):107-113. doi: 10.1002/pon.5243. Epub 2019 Oct 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina Bertero, RN,professor study director
Department of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by Jenny Drott at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxaliplatin-Specific Neurotoxicity Scale (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02412683, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.