CancerNCT02317757
Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients
An observational study of Cancer, run by Mahidol University at 1 site in Thailand.
Trial summary
These days, there is higher proportion of elderly cancer patients. Most of them have comorbidities, borderline performance status and nutritional status. The discontinuation of chemotherapy due to unbearable toxicities was not uncommon. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to Dec 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: cancer patients who are older than 70 years old and receiving chemotherapy
Who may be able to join
- more than 70 years of age
- plan to receive first cycle of chemotherapy
- histologically or cytologically proved of cancer
Who cannot join
- patients who have concurrent chemoradiotherapy
- patients who received local chemotherapy
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Division of medical oncology, department of medicine Siriraj Hospital
Bangkok, 10700
Suthinee Ithimakin, MD, 662-419-4489, aesi105@yahoo.co.th
Suthinee Ithimakin, MD
About this study
Official title: Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients: A Prospective Study
These days, there is higher proportion of elderly cancer patients. Most of them have comorbidities, borderline performance status and nutritional status. The discontinuation of chemotherapy due to unbearable toxicities was not uncommon. Comprehensive geriatric assessment might be beneficial in selection of suitable elderly patients for chemotherapy administration.
Read the detailed description
The patients with the age more than 70 years old who scheduled for chemotherapy were enrolled. Geriatric assessment was performed before starting chemotherapy. The toxicity will be recorded prospectively. Predisposing factors of grade 3 and 4 toxicity will be reported.
- Conditions
- Cancer
- Keywords
- elderly cancer patients, chemotherapy toxicity
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cancer patients receiving chemotherapy | Patients who are older than 70 years old receiving chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
predisposing factors of patients developed grade 3 or 4 chemotherapy toxicity
Measured: from starting chemotherapy to 1 month after last dose of chemotherapy
Secondary outcomes (2)
incidence of grade 3 or 4 chemotherapy toxicity in elderly
Measured: from starting chemotherapy to 1 month after last dose of chemotherapy
Factors associated with good quality of life during receiving chemotherapy
Measured: from starting chemotherapy to 1 month after last dose of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suthinee Ithimakin, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317757
- Sponsor's protocol ID
- 559/2557(EC3)
- Status last verified
- Mar 2016
- First submitted
- 11 Dec 2014
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predisposing Factors Associated With Chemotherapy Toxicity in Elderly Cancer Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT02317757
- Acronym / sponsor ID
- 559/2557(EC3)
- Conditions
- Cancer
- Keywords
- elderly cancer patients, chemotherapy toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 16 Dec 2014 (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.
These days, there is higher proportion of elderly cancer patients. Most of them have comorbidities, borderline performance status and nutritional status. The discontinuation of chemotherapy due to unbearable toxicities was not uncommon. Comprehensive geriatric assessment might be beneficial in selection of suitable elderly patients for chemotherapy administration.
Detailed description
The patients with the age more than 70 years old who scheduled for chemotherapy were enrolled. Geriatric assessment was performed before starting chemotherapy. The toxicity will be recorded prospectively. Predisposing factors of grade 3 and 4 toxicity will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cancer patients receiving chemotherapy | – | –Patients who are older than 70 years old receiving chemotherapy |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- cancer patients who are older than 70 years old and receiving chemotherapy
Key inclusion criteria (3 listed)
- more than 70 years of age
- plan to receive first cycle of chemotherapy
- histologically or cytologically proved of cancer
Key exclusion criteria (2 listed)
- patients who have concurrent chemoradiotherapy
- patients who received local chemotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
predisposing factors of patients developed grade 3 or 4 chemotherapy toxicity
Time frame: from starting chemotherapy to 1 month after last dose of chemotherapy
2 secondary outcomes
incidence of grade 3 or 4 chemotherapy toxicity in elderly
Time frame: from starting chemotherapy to 1 month after last dose of chemotherapy
Factors associated with good quality of life during receiving chemotherapy
Time frame: from starting chemotherapy to 1 month after last dose of chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Individual participant dataSharing planned: No
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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.
Suthinee Ithimakin, MD principal investigator
Mahidol University
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 Cancer, run by Mahidol University at 1 site in Thailand.
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 2 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: status not confirmed, as of the sponsor's last update on 4 Apr 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suthinee Ithimakin, MD (66898127440, Aesi105@yahoo.co.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predisposing factors of patients developed grade 3 or 4 chemotherapy toxicity (time frame: from starting chemotherapy to 1 month after last dose of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2016.