Esophageal CancerNCT01738633
Quality of Life After Esophagectomy for Cancer - Step 2
A study testing nutritional counseling and respirology counseling in people with Esophageal Cancer and Quality of Life, run by University of Padova at 1 site in Italy.
Trial summary
Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Quality of Life
- What is being tested?
- nutritional counseling and respirology counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2013to Apr 2018
- Phase
- Interventional
- 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
Who may be able to join
- age above 18 years old
- scheduled for esophagectomy for cancer
Who cannot join
- age below 18 years old
- incapability to autonomously fill in questionnaires
- primary language not italian
Trial locations and contacts
1 site in 1 country.
About this study
Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care.
The study is divided into two steps.
Read more
This is step 2.
At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.
- Conditions
- Esophageal Cancer, Quality of Life
- Being tested
- nutritional counseling, respirology counseling
- Keywords
- Esophageal Cancer, Quality of Life
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nutritional counselingBehavioural
respirology counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| nutritional + respirology counseling | Experimental | patients will receive both nutritional and respirology counseling Receives: Behavioral: nutritional counseling; Behavioral: respirology counseling |
| nutritional counseling | Experimental | patients will receive nutritional counseling alone Receives: Behavioral: nutritional counseling |
| respirology counseling | Experimental | patients will receive respirology counseling alone Receives: Behavioral: respirology counseling |
| standard care | No intervention | patients will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Measured: 1 month after surgical operation
Secondary outcomes (3)
item EA (eating) of OES18
Measured: 1 month after surgical operation
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Measured: 3 months after surgical operation
item EA (eating) of OES18
Measured: 3 months after surgical operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2017
- Study completionApr 2018
Why it stopped: Surgical Unit closed and moved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Guido Berlucchi, Istituto Oncologico Veneto IRCCS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738633
- Sponsor's protocol ID
- QOLEC1 - step 2
- Status last verified
- May 2018
- First submitted
- 20 Oct 2012
- Last updated
- 23 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Esophagectomy for Cancer - Step 2
- ClinicalTrials.gov ID
- NCT01738633
- Acronym / sponsor ID
- QOLEC1 - step 2
- Conditions
- Esophageal Cancer, Quality of Life
- Keywords
- Esophageal Cancer, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Surgical Unit closed and moved.
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Collaborators
- Fondazione Guido Berlucchi, Istituto Oncologico Veneto IRCCS
- Study start
- Jan 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 30 Nov 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.
Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care.
The study is divided into two steps.
This is step 2.
At hospital discharge, patients will be randomized into 4 groups receiving respectively: nutritional and respirology counseling; nutritional counseling alone; respirology counseling alone; standard care. All the patients fill in the questionnaires QLQ C30, OES18, INPAT32 at 1 and 3 months after the surgical operation. Primary end-points are the items DY (dyspnoea), AP (appetite loss) and QL2 of QLQ C30. Secondary end point is the item EA (eating) of OES18.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| nutritional + respirology counseling | Experimental | Behavioral: nutritional counseling, Behavioral: respirology counselingpatients will receive both nutritional and respirology counseling |
| nutritional counseling | Experimental | Behavioral: nutritional counselingpatients will receive nutritional counseling alone |
| respirology counseling | Experimental | Behavioral: respirology counselingpatients will receive respirology counseling alone |
| standard care | No intervention | –patients will receive standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age above 18 years old
- scheduled for esophagectomy for cancer
Key exclusion criteria (3 listed)
- age below 18 years old
- incapability to autonomously fill in questionnaires
- primary language not italian
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 |
|---|---|---|
| nutritional counseling | Behavioural | nutritional + respirology counseling, nutritional counseling |
| respirology counseling | Behavioural | nutritional + respirology counseling, respirology counseling |
Primary outcome
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Time frame: 1 month after surgical operation
3 secondary outcomes
item EA (eating) of OES18
Time frame: 1 month after surgical operation
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30
Time frame: 3 months after surgical operation
item EA (eating) of OES18
Time frame: 3 months after surgical operation
Results and safety
The study was stopped early (reason given: Surgical Unit closed and moved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutritional counseling and respirology counseling in people with Esophageal Cancer and Quality of Life, run by University of Padova at 1 site in Italy.
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 2 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: stopped early, as of the sponsor's last update on 23 May 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 Italy. 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 was stopped early (reason given: Surgical Unit closed and moved.). Results are not available in the source record.
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?
items DY (dyspnoea), AP (appetite loss) and QL2 of the QLQ C30 (time frame: 1 month after surgical operation). 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 23 May 2018.