Cancer of Head and NeckENHANCENCT01681654
Exercise and Nutrition for Head and Neck Cancer Patients
A study testing Lifestyle Intervention and Maintenance Intervention in people with Cancer of Head and Neck, run by University of Calgary at 2 sites in Canada.
Trial summary
Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations. This translates into a lack of clinical programming available for these patient populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- Lifestyle Intervention and Maintenance Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2012to Dec 2014
- 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
- Over 18 Years of Age
- Has received a diagnosis of nasopharyngeal, oropharyngeal or hypopharyngeal cancer
- Will receive radiation as part of treatment plan
- Able to walk without assistance
- Received clearance for exercise from treating oncologist
- Lives in Calgary, Alberta area
- Can speak and write English
- Is interested in participating in the study
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
University of Calgary
Calgary, Alberta, T2N1N4
Tom Baker Cancer Centre
Calgary, Alberta, T2N4N2
About this study
Official title: Exercise and Nutrition for Head and Neck Cancer Patients: A Patient Oriented, Clinic-Supported Randomized Controlled Trial
Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations. This translates into a lack of clinical programming available for these patient populations. Head and neck cancer patients deal with severe weight loss, with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Therefore, the purpose of the present study is to examine the impact of timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, the investigators will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work. The investigators hypothesize that (1) patients who are randomized to the intervention at treatment start will experience improved symptom management and decreased lean body composition changes, directly improving recovery and QoL; (2) patients who receive a maintenance support program will have better long-term adherence and therefore superior treatment-related symptom management, physical and psychosocial functioning; and (3) return to work indices will improve and healthcare utilization costs will be lower in the participants who receive the immediate intervention (vs. delayed) as well as in those who receive the maintenance program (vs. no maintenance). This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical activity and wellness education model that can be implemented in other cancer centers.
- Conditions
- Cancer of Head and Neck
- Being tested
- Lifestyle Intervention, Maintenance Intervention
- Keywords
- Head/Neck Cancer, Exercise, Progressive Strength Training, Quality of Life, Cancer, Randomized Controlled Trial, Nutrition, Lifestyle Intervention
- Medical subject headings
- Head and Neck Neoplasms, Motor Activity, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week. In addition, participants will be required to attend six education sessions during the 12-week intervention.
Maintenance InterventionBehavioural
Patients randomized to receive the Maintenance Program Intervention following treatment will receive a Survivorship Care Plan outlining their physical activity, dietary, and health behaviour progress throughout the program, future goals, individualized maintenance strategies, and optional drop-in exercise sessions.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Lifestyle Intervention - Maintenance Program | Experimental | Patients will receive a 12-week lifestyle program during treatment. Patients will also receive maintenance support following the 12-week program. Receives: Behavioral: Lifestyle Intervention; Behavioral: Maintenance Intervention |
| Immediate Lifestyle Intervention - No Maintenance Program | Experimental | Patients will begin the 12-week lifestyle intervention during treatment. Patients will not receive a maintenance support following the 12-week intervention. Receives: Behavioral: Lifestyle Intervention |
| Delayed Lifestyle Intervention - Maintenance Program | Experimental | Patients will receive a 12-week lifestyle intervention program following treatment (12 weeks after diagnosis). Patients will then receive maintenance support following the 12-week program. Receives: Behavioral: Lifestyle Intervention; Behavioral: Maintenance Intervention |
| Delayed Lifestyle Intervention - No Maintenance Program | Experimental | Patients will receive a 12-week lifestyle intervention program following treatment completion (12 weeks following diagnosis). Patients will not receive maintenance support following the 12-week program. Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Body Composition
DXA Scan will be used to assess body composition
Measured: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Secondary outcomes (16)
Quality of Life
Quality of Life will be assessed using the Functional Assessment of Cancer Therapy- Anemia module (FACT-AN), and the NCCN-FACT Fact Head/Neck Symptom Index-22 (FHNSI-22).
Measured: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Physical Activity Behaviour
Physical activity will be assessed using Godin's (Godin, 1985) leisure score index (LSI) of the GLTEQ (Godin Leisure Time Exercise Questionnaire).
Measured: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Smoking History
Smoking history will be assessed by a self report questionnaire which will classify patients as non-smokers, former smokers and current smokers.
Measured: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Depression
Depression will be assessed using the Center for Epidemiological Studies on Depression Scale (CES-D).
Measured: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Karnofsky Performance Score (KPS)
The Karnofsky Performance Score (KSP) will be used to measure the participant's general ability to accomplish tasks of daily-living and overall well-being.
Measured: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Inflammatory Markers
Inflammatory factors will be evaluated as they are associated with cancer cachexia and muscle wasting and may be modified by exercise (Seruga et al., 2008; Baldwin, 2011). An overnight fasted blood draw will be collected at baseline, 3 months post diagnosis, 6 months post diagnosis, 9 months post diagnosis, and 12 months post diagnosis. Serum inflammatory cytokine concentrations will be assessed in-house (Dr. Raylene Reimer's laboratory) according to our established protocols. TNF, IL-6, IL-1, IL-8 and C-reactive protein will be quantified using Milliplex Human Cytokine kits (Millipore, Billerica, MA). Plate reading will be provided as a fee-for service through Eve Technologies Inc. (Calgary, AB).
Measured: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Cancer related Symptom Management
Participants will complete the ESAS bi-weekly, before and after class. The ESAS is a valid and reliable assessment tool to evaluate the nine more common symptoms experienced by cancer patients (Chang et al., 2000).
Measured: At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention
Diet Behaviour - 3 Day food record
The 3-Day Diet Record is said to be the most accurate for mean macronutrient content and appropriate for use in studies where subjects may consume a wide variety of foods (American Dietetics Association / Dietitians Canada, 2000). Participants are instructed to record their daily consumption over a period of three days, one of which must be a weekend day. Written instructions and a sample entry are provided to increase accuracy of the daily record.
Measured: At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.
Diet Behaviour: PG-SGA
The PG-SGA assessment tool has been show to improve treatment outcomes, decrease side-effects, and improve weight-management in cancer patients, and therefore will be used weekly to assess and identify malnutrition among patients (McMahon et al., 2000; Doyle et al., 2006).
Measured: At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis
Health related Fitness Measures - Resting Heart Rate
Resting heart rate will be measured by palpating the radial artery and taking a 15 second count as per the CPAFLA protocol (CPAFLA, 2003).
Measured: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
Health Related Fitness Outcome - Blood Pressure
A resting blood pressure (mmHg) will be measured in duplicate on the left arm using a sphygmomanometer and stethoscope using standardized procedures (CPAFLA, 2003).
Measured: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
Health Related Fitness Outcome - 6 minute walk test
The six-minute walk test (6MWT) will be used to assess changes in functional aerobic capacity. Using the standardized protocol, participants will be asked to walk as far as they can around a 400-meter track for six minutes [43]. The point reached at 6 minutes will be marked and measured to the nearest 0.5 meter. Rating of perceived exertion (Borg scale) will be completed immediately after completion of the functional aerobic capacity test.
Measured: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
Health Related Fitness Outcome - Grip Strength
Muscular strength will be assessed using a combined grip strength of the right and left hands will also be assessed using a hand dynamometer. A sum will be determined in kilograms from the best score of 2 trials recorded for each hand according to the CPAFLA protocol.
Measured: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.
Health Related Fitness Outcome - Lower Body Strength
Lower body strength will be assessed using a 30-second sit to stand test. The number of times participants can stand from a seated position in 30-second will be examined.
Measured: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis
Health Related Fitness Outcome - Flexibility
Flexibility will be assessed by a trunk forward flexion sit-and-reach test using a Wells-Dillon flexometer. The test will follow a standard protocol, with two trials allowed and the highest score to the nearest 0.5 cm recorded.
Measured: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis
Health Related Fitness Outcome - Balance
Balance will be assessed using a static balance test. The test requires the participant to balance on one foot and then the other as long as they can (length of time to a maximum of 45 seconds) while standing on a 2.54 by 2.54 by 30.5 cm base using a standardized protocol, reported by Fleishman.
Measured: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2014
- Study completionDec 2014
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 Cancer of Head and NeckStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Cancer Foundation
- Responsible party
- Principal investigator, Dr. Nicole Culos-Reed, University of Calgary
- Investigators
- Nicole Culos-Reed, PhD, Principal investigator, University of CalgaryLauren C Capozzi, PhD Student, Study director, University of CalgaryHarold Lau, MD, Principal investigator, Tom Baker Cancer Centre, University of CalgaryRaylene Reimer, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681654
- Sponsor's protocol ID
- ENHANCE10001991
- Acronym
- ENHANCE
- Status last verified
- Oct 2016
- First submitted
- 31 Aug 2012
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Capozzi LC, Lau H, Reimer RA, McNeely M, Giese-Davis J, Culos-Reed SN. Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial. BMC Cancer. 2012 Oct 2;12:446. doi: 10.1186/1471-2407-12-446.
PubMed 23031071
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Nutrition for Head and Neck Cancer Patients: A Patient Oriented, Clinic-Supported Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01681654
- Acronym / sponsor ID
- ENHANCE / ENHANCE10001991
- Conditions
- Cancer of Head and Neck
- Keywords
- Head/Neck Cancer, Exercise, Progressive Strength Training, Quality of Life, Cancer, Randomized Controlled Trial, Nutrition, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Cancer Foundation
- Study start
- Jun 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Sep 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.
Research on physical activity and nutrition interventions aimed at positively impacting symptom management, treatment-related recovery and quality of life has largely excluded head and neck cancer populations. This translates into a lack of clinical programming available for these patient populations. Head and neck cancer patients deal with severe weight loss, with upwards of 70% attributed to lean muscle wasting, leading to extended recovery times, decreased quality of life (QoL), and impaired physical functioning. To date, interventions to address body composition issues have focused solely on diet, despite findings that nutritional therapy alone is insufficient to mitigate changes. A combined physical activity and nutrition intervention, that also incorporates important educational components known to positively impact behaviour change, is warranted for this population. Pilot work suggests that there is large patient demand and clinic support from the health care professionals for a comprehensive program. Therefore, the purpose of the present study is to examine the impact of timing of a 12-week PA and nutrition intervention (either during or following treatment) for HN cancer patients on body composition, recovery, serum inflammatory markers and quality of life. In addition, the investigators will examine the impact of a 12-week maintenance program, delivered immediately following the intervention, on adherence, patient-reported outcomes (i.e., management of both physical and psychosocial treatment-related symptoms and side-effects), as well as return to work. The investigators hypothesize that (1) patients who are randomized to the intervention at treatment start will experience improved symptom management and decreased lean body composition changes, directly improving recovery and QoL; (2) patients who receive a maintenance support program will have better long-term adherence and therefore superior treatment-related symptom management, physical and psychosocial functioning; and (3) return to work indices will improve and healthcare utilization costs will be lower in the participants who receive the immediate intervention (vs. delayed) as well as in those who receive the maintenance program (vs. no maintenance). This research will facilitate advancements in patient wellness, survivorship, and autonomy, and carve the path for a physical activity and wellness education model that can be implemented in other cancer centers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immediate Lifestyle Intervention - Maintenance Program | Experimental | Behavioral: Lifestyle Intervention, Behavioral: Maintenance InterventionPatients will receive a 12-week lifestyle program during treatment. Patients will also receive maintenance support following the 12-week program. |
| Immediate Lifestyle Intervention - No Maintenance Program | Experimental | Behavioral: Lifestyle InterventionPatients will begin the 12-week lifestyle intervention during treatment. Patients will not receive a maintenance support following the 12-week intervention. |
| Delayed Lifestyle Intervention - Maintenance Program | Experimental | Behavioral: Lifestyle Intervention, Behavioral: Maintenance InterventionPatients will receive a 12-week lifestyle intervention program following treatment (12 weeks after diagnosis). Patients will then receive maintenance support following the 12-week program. |
| Delayed Lifestyle Intervention - No Maintenance Program | Experimental | Behavioral: Lifestyle InterventionPatients will receive a 12-week lifestyle intervention program following treatment completion (12 weeks following diagnosis). Patients will not receive maintenance support following the 12-week program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Over 18 Years of Age
- Has received a diagnosis of nasopharyngeal, oropharyngeal or hypopharyngeal cancer
- Will receive radiation as part of treatment plan
- Able to walk without assistance
- Received clearance for exercise from treating oncologist
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Lifestyle InterventionParticipants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week. In addition, participants will be required to attend six education sessions during the 12-week intervention. | Behavioural | Delayed Lifestyle Intervention - Maintenance Program, Delayed Lifestyle Intervention - No Maintenance Program, Immediate Lifestyle Intervention - Maintenance Program, Immediate Lifestyle Intervention - No Maintenance Program |
| Maintenance InterventionPatients randomized to receive the Maintenance Program Intervention following treatment will receive a Survivorship Care Plan outlining their physical activity, dietary, and health behaviour progress throughout the program, future goals, individualized maintenance strategies, and optional drop-in exercise sessions. | Behavioural | Delayed Lifestyle Intervention - Maintenance Program, Immediate Lifestyle Intervention - Maintenance Program |
Primary outcome
Change from Baseline in Body Composition
Time frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
DXA Scan will be used to assess body composition
16 secondary outcomes
Quality of Life
Time frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Physical Activity Behaviour
Time frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Smoking History
Time frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Depression
Time frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Karnofsky Performance Score (KPS)
Time frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Inflammatory Markers
Time frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis
Cancer related Symptom Management
Time frame: At baseline (diagnosis) and then 3, 6, 9, 12 months post diagnosis & every week before and after class during the 12 week intervention
Diet Behaviour - 3 Day food record
Time frame: At baseline (diagnosis) and 4 & 8 weeks, 3, 6, 9, 12 months post diagnosis.
Diet Behaviour: PG-SGA
Time frame: At baseline (diagnosis), each week during radiation treatment (6.5 weeks in duration), and 3, 6, 9, 12 months post diagnosis
Health related Fitness Measures - Resting Heart Rate
Time frame: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
Health Related Fitness Outcome - Blood Pressure
Time frame: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
Health Related Fitness Outcome - 6 minute walk test
Time frame: At baseline (diagnosis), and 3, 6, 9, 12 months post diagnosis.
Health Related Fitness Outcome - Grip Strength
Time frame: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis.
Health Related Fitness Outcome - Lower Body Strength
Time frame: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis
Health Related Fitness Outcome - Flexibility
Time frame: At baseline (diagnosis) and 3, 6, 9, and 12 months post diagnosis
Health Related Fitness Outcome - Balance
Time frame: At baseline (diagnosis), and 3, 6, 9, and 12 months post diagnosis.
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 26 Oct 2016.
- Derived from this study: PubMed 23031071Capozzi LC, Lau H, Reimer RA, McNeely M, Giese-Davis J, Culos-Reed SN. Exercise and nutrition for head and neck cancer patients: a patient oriented, clinic-supported randomized controlled trial. BMC Cancer. 2012 Oct 2;12:446. doi: 10.1186/1471-2407-12-446.
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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.
Nicole Culos-Reed, PhD principal investigator
University of Calgary
Lauren C Capozzi, PhD Student study director
University of Calgary
Harold Lau, MD principal investigator
Tom Baker Cancer Centre, University of Calgary
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention and Maintenance Intervention in people with Cancer of Head and Neck, run by University of Calgary at 2 sites in Canada.
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 8 inclusion and 0 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 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Change from Baseline in Body Composition (time frame: At baseline (diagnosis), and then at 3, 6, 9 and 12 months post diagnosis). 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 NCT01681654, 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 26 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.