Pre-treatment Loss of Independent Activities of Daily LivingNCT01752751
Predicting Tolerance to Radiation Therapy in Older Adults With Cancer
An observational study of Pre-treatment Loss of Independent Activities of Daily Living, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict how older adults tolerate cancer treatments. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pre-treatment Loss of Independent Activities of Daily Living
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 2015
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients age ≥ 65 years of age, with one of the inclusion diagnoses, and an appointment for CT simulation for planning of radiation therapy at UNCH department of radiation oncology will be assessed for inclusion for this study.
Who may be able to join
- ≥Age 65 years (no upper age limit)
- Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of External Beam Radiation Therapy (EBRT) at UNC Chapel Hill
- Able to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
- Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
Who cannot join
- ≥Age 65 years (no upper age limit)
- Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of EBRT at UNC Chapel Hill
- Able to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
- Patients enrolled in other CGA studies will not be excluded (see LCCC 0916, 1208)
Trial locations and contacts
1 site in 1 country.
United States1 site
Radiation Oncology Clinic - UNC Cancer Hospital
Chapel Hill, North Carolina, 27599
About this study
Official title: Predicting Tolerance to Radiation Therapy in Older Adults With Cancer: A Prospective Blinded Study of the Comprehensive Geriatric Assessment
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict how older adults tolerate cancer treatments. The investigators think this same tool (referred to as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.
Read the detailed description
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict for toxicity in older patients during cancer treatments.1 The investigators hypothesize that the same tool (referred to throughout this document as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance. The primary objective of this study is to assess the association between pre-treatment functional status (as measured by the Independent Activities of Daily Living (I-ADL) components of the CGA) and poor tolerance to radiation therapy (as defined in section 2.3.1). Secondary objectives include exploration of associations between pre-treatment I-ADL status on the CGA and the occurrence of any acute grade 3-5 toxicity from radiation therapy, or any decrease in Quality of Life (QoL) measures throughout radiation therapy as assessed by the EORTC QLQ-C30 questionnaire. The investigators also want to compare the rate of physician reported acute toxicities to patient reported acute toxicities in an older cancer patient population, assess any association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to or acute grade 3-5 toxicity from radiation therapy, and explore any association between other baseline components of the CGA and poor tolerance to or acute grade 3-5 toxicity from radiation therapy.
- Keywords
- Neck cancer, Head cancer, Lung cancer
- Medical subject headings
- Head and Neck Neoplasms, Lung 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 Age 65 or above | Cancer patients age 65 years or above with a diagnosis of head and neck cancer or lung cancer with radiotherapy or chemoradiotherapy planned as part of curative standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy
To assess the association between pre-treatment loss of at least one independent activity of daily living (I-ADL) on the CGA and poor tolerance to radiation therapy
Measured: 4-8 weeks post-radiation therapy
Secondary outcomes (5)
Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and the occurrence of any patient-reported toxicity from radiation therapy
To assess the association between pre-treatment loss of at least one I-ADL on the CGA and the occurrence of any patient-reported acute grade 3-5 toxicity from radiation therapy
Measured: 4-8 weeks post-radiation therapy
Association between pre-treatment loss of at least one independent activity of daily living and changes in Quality of Life measures
To assess the association between pre-treatment loss of at least one I-ADL on the CGA and changes in QoL measures, as evaluated by the EORTC-QLQ-C30 throughout radiation therapy
Measured: 4-8 weeks post radiation therapy
Comparison of physician and patient-reported acute grade 3-5 toxicities
To compare physician-reported acute grade 3-5 toxicities to patient-reported grade 3-5 acute toxicities in this older adult population.
Measured: 4-8 weeks post-radiation therapy
Association between elevated p16Ink4α gene expression and poor tolerance to and/or physician/patient-reported toxicity from radiation therapy
To assess the association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to and/or patient reported and physician reported acute grade 3-5 toxicity from radiation therapy
Measured: 4-8 weeks post-radiation therapy
Association between baseline components of the Comprehensive Geriatric Assessment and poor tolerance to or occurrence of patient-reported toxicity from radiation treatment
To explore the association between baseline components of the CGA (other than I-ADL) and poor tolerance to or occurrence of any patient-reported acute grade 3-5 toxicity from radiation treatment.
Measured: 4-8 weeks post-radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2015
- Study completionMar 2015
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 Pre-treatment Loss of Independent Activities of Daily LivingStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Alpha Omega Alpha Honor Medical Society
- Responsible party
- Sponsor
- Investigators
- Bhishamjit Chera, MD, Principal investigator, Radiation Oncology UNC Cancer HospitalNoam VanderWalde, MD, Study director, Radiation Oncology UNC Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752751
- Sponsor's protocol ID
- LCCC 1224
- Other IDs
- 1224, 121731
- Status last verified
- May 2018
- First submitted
- 14 Dec 2012
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
VanderWalde NA, Deal AM, Comitz E, Stravers L, Muss H, Reeve BB, Basch E, Tepper J, Chera B. Geriatric Assessment as a Predictor of Tolerance, Quality of Life, and Outcomes in Older Patients With Head and Neck Cancers and Lung Cancers Receiving Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):850-857. doi: 10.1016/j.ijrobp.2016.11.048. Epub 2016 Dec 2.
PubMed 28258889
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Tolerance to Radiation Therapy in Older Adults With Cancer: A Prospective Blinded Study of the Comprehensive Geriatric Assessment
- ClinicalTrials.gov ID
- NCT01752751
- Acronym / sponsor ID
- LCCC 1224
- Keywords
- Neck cancer, Head cancer, Lung cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Alpha Omega Alpha Honor Medical Society
- Study start
- Nov 2012 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Dec 2012 (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.
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict how older adults tolerate cancer treatments. The investigators think this same tool (referred to as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance.
Detailed description
A comprehensive geriatric assessment tool developed by Hurria and colleagues has been used in non-radiation oncology clinical settings to predict for toxicity in older patients during cancer treatments.1 The investigators hypothesize that the same tool (referred to throughout this document as the CGA) can be used in a radiation oncology clinic to predict for poor treatment tolerance. The primary objective of this study is to assess the association between pre-treatment functional status (as measured by the Independent Activities of Daily Living (I-ADL) components of the CGA) and poor tolerance to radiation therapy (as defined in section 2.3.1). Secondary objectives include exploration of associations between pre-treatment I-ADL status on the CGA and the occurrence of any acute grade 3-5 toxicity from radiation therapy, or any decrease in Quality of Life (QoL) measures throughout radiation therapy as assessed by the EORTC QLQ-C30 questionnaire. The investigators also want to compare the rate of physician reported acute toxicities to patient reported acute toxicities in an older cancer patient population, assess any association between elevated p16Ink4α expression in peripheral T lymphocytes and poor tolerance to or acute grade 3-5 toxicity from radiation therapy, and explore any association between other baseline components of the CGA and poor tolerance to or acute grade 3-5 toxicity from radiation therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer Patients Age 65 or above | – | –Cancer patients age 65 years or above with a diagnosis of head and neck cancer or lung cancer with radiotherapy or chemoradiotherapy planned as part of curative standard treatment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients age ≥ 65 years of age, with one of the inclusion diagnoses, and an appointment for CT simulation for planning of radiation therapy at UNCH department of radiation oncology will be assessed for inclusion for this study.
Key inclusion criteria (6 listed)
- ≥Age 65 years (no upper age limit)
- Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of External Beam Radiation Therapy (EBRT) at UNC Chapel Hill
- Able to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
Key exclusion criteria (6 listed)
- ≥Age 65 years (no upper age limit)
- Diagnosis of either head and neck cancer, or lung cancer with either radiotherapy or chemoradiotherapy planned as part of standard treatment.
- Consented for receipt of EBRT at UNC Chapel Hill
- Able to read English (required for CGA)
- Curative treatment intent as defined by their radiation oncologist Signed, IRB-approved written informed consent
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
Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy
Time frame: 4-8 weeks post-radiation therapy
To assess the association between pre-treatment loss of at least one independent activity of daily living (I-ADL) on the CGA and poor tolerance to radiation therapy
5 secondary outcomes
Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and the occurrence of any patient-reported toxicity from radiation therapy
Time frame: 4-8 weeks post-radiation therapy
Association between pre-treatment loss of at least one independent activity of daily living and changes in Quality of Life measures
Time frame: 4-8 weeks post radiation therapy
Comparison of physician and patient-reported acute grade 3-5 toxicities
Time frame: 4-8 weeks post-radiation therapy
Association between elevated p16Ink4α gene expression and poor tolerance to and/or physician/patient-reported toxicity from radiation therapy
Time frame: 4-8 weeks post-radiation therapy
Association between baseline components of the Comprehensive Geriatric Assessment and poor tolerance to or occurrence of patient-reported toxicity from radiation treatment
Time frame: 4-8 weeks post-radiation therapy
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 4 Jun 2018.
- Background: PubMed 28258889VanderWalde NA, Deal AM, Comitz E, Stravers L, Muss H, Reeve BB, Basch E, Tepper J, Chera B. Geriatric Assessment as a Predictor of Tolerance, Quality of Life, and Outcomes in Older Patients With Head and Neck Cancers and Lung Cancers Receiving Radiation Therapy. Int J Radiat Oncol Biol Phys. 2017 Jul 15;98(4):850-857. doi: 10.1016/j.ijrobp.2016.11.048. Epub 2016 Dec 2.
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.
Bhishamjit Chera, MD principal investigator
Radiation Oncology UNC Cancer Hospital
Noam VanderWalde, MD study director
Radiation Oncology UNC Cancer Hospital
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 Pre-treatment Loss of Independent Activities of Daily Living, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
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 6 inclusion and 6 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 4 Jun 2018. 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 United States. 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?
Association between pre-treatment loss of at least one independent activity of daily living (I-ADL) and poor tolerance to radiation therapy (time frame: 4-8 weeks post-radiation therapy). 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 NCT01752751, 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 4 Jun 2018.