The Wessex Fit-4-Cancer Surgery Trial (WesFit)

May 8, 2019 updated by: University Hospital Southampton NHS Foundation Trust

A Pragmatic Factorial Design Randomised Controlled Study to Assess the Efficacy of the Implementation of a Prehabilitation Programme in Patients Undergoing Elective Major Intra - Cavity Cancer Surgery in Wessex

Trial Phase: Phase III: A multi-centre efficacy pragmatic factorial design randomised controlled trial with patient informed development and process evaluation

Indication: Patients undergoing major electively resectable intra - cavity cancer surgery with or without neoadjuvant cancer treatments (including chemotherapy (NAC), chemoradiotherapy (CRT), or immunotherapy).

Objective: To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support on surgical outcome by reducing postoperative length of stay (LOS) and complications.

Secondary Objective:

To investigate the efficacy of a community based Structured Responsive Exercise-training Programme (SRETP) ± psychological support to improve disease-free overall survival. Cardiopulmonary Exercise test (CPET) variables, physical activity, morbidity, radiological markers of sarcopenia, toxicity, tumour down-staging, tumour regression, disability adjusted survival (WHODAS) overall survival and quality of life (QoL).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Rationale: Fitter patients have better surgical outcomes. Poor physical fitness measured objectively using cardiopulmonary exercise testing has been associated with increased LOS, increased morbidity and mortality in many patient cohorts undergoing major cancer surgery. Chemotherapy and radiotherapy have detrimental effects on physical fitness, which may in turn have a detrimental effect on the patients' ability to withstand surgery. Research suggests psychological factors including depression and self-efficacy (confidence to manage cancer-related problems) prior to surgery predict recovery trajectories in health-related quality of life up to 2 years after major surgery for colorectal cancer.

The aim is to investigate whether SRETP (Prehabilitation) ± psychological support prior to and during cancer treatment before major elective surgery reduces LOS, increases survival and improves their ability to self manage. Additionally, we aim to see if this intervention can bring about long-term behavioural change in relation to physical activity.

Trial Design: Phase III: A pragmatic factorial design randomised controlled to assess the effectiveness of a prehabilitation programme delivered prior to cancer treatments and/or major cancer surgery in patients undergoing elective intra-cavity major cancer surgery in Wessex.

Sample size: 1560

Intervention:

  1. An in-hospital transition to a community based Structured Responsive Exercise-Training Programme (SRETP) ± psychological support (delivered in community/ council gyms or Cancer Support Centers). The intervention/s will be delivered before surgery. Patients receiving neoadjuvant cancer treatments prior to surgery will receive the intervention during and after these treatments.
  2. Control: Standard care with extra monitoring

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1560

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Southampton, United Kingdom
        • Recruiting
        • University Hopsitals Southampton
        • Contact:
          • Sandy Jack, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients
  • aged over 18 years old
  • scheduled to have major intra-cavity cancer surgery with a curative intent, defined as thoracic, colorectal, oesophagogastric, urological and hepatobiliary (inc. pancreatic).
  • surgery alone (unimodal)
  • surgery combined (multimodal) with cancer treatments (neoadjuvant chemotherapy, chemoradiotherapy or immunotherapies).
  • All patients deemed by the MDT as potentially curable or undergoing neoadjuvant cancer treatments prior to restaging and surgery.

Exclusion Criteria:

  • Patients will be excluded if under the age of 18 years,
  • if their tumour is considered surgically non- resectable,
  • having absolute or relative contraindications to completing a CPET,
  • patients are unable to perform CPET due to other coexisting acute illness or conditions (e.g. lower limb dysfunction),
  • patients decline surgery,
  • if their weight exceeds 145kg
  • patients unable to give informed consent.
  • Patients having >2 mm ST depression if symptomatic or 4 mm if asymptomatic or >1 mm ST elevation during any CPET will need to be withdrawn from study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Usual care plus additional monitoring
Experimental: SRETP
Structured Responsive Exercise Training Programme (SRETP) prior to surgery
Behavioral: SRETP
SRETP will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. Exercise intensities during the interval exercise-training program are specific to each patient and derived from CPET. Moderate intensity exercise is below the anaerobic threshold (AT). Patients will exercise at 80% of oxygen uptake (VO2) obtained at the anaerobic threshold (80%AT) for moderate intensity exercise - 3 minutes. Severe exercise intensity is recognised as 50% of the difference between the VO2 AT and VO2 Peak (50%∆) - 2 minutes.
Experimental: Psychological support
Psychological support prior to surgery
Behavioral: Psychological support
Support sessions will be patient-centred, giving the patient an opportunity to raise any issues/concerns they are having, this may include (but will not be limited to) ways of coping with their reactions to cancer, family and relationship issues, exploring personal issues and dealing with practical issues. Patients will have access to other resources available at the cancer centres including but not restricted to further information about their condition and how to access financial support. These processes reflect the best practice currently being delivered by cancer support centre staff in the Wessex region. Any patient deemed at risk (i.e. from suicidal ideation or self harm) will be reported to their GP, followed up by a letter.
Experimental: SRETP and psychological support
Structured Responsive Exercise Training Programme (SRETP) and psychological support prior to surgery
Behavioral: SRETP
SRETP will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. Exercise intensities during the interval exercise-training program are specific to each patient and derived from CPET. Moderate intensity exercise is below the anaerobic threshold (AT). Patients will exercise at 80% of oxygen uptake (VO2) obtained at the anaerobic threshold (80%AT) for moderate intensity exercise - 3 minutes. Severe exercise intensity is recognised as 50% of the difference between the VO2 AT and VO2 Peak (50%∆) - 2 minutes.
Behavioral: Psychological support
Support sessions will be patient-centred, giving the patient an opportunity to raise any issues/concerns they are having, this may include (but will not be limited to) ways of coping with their reactions to cancer, family and relationship issues, exploring personal issues and dealing with practical issues. Patients will have access to other resources available at the cancer centres including but not restricted to further information about their condition and how to access financial support. These processes reflect the best practice currently being delivered by cancer support centre staff in the Wessex region. Any patient deemed at risk (i.e. from suicidal ideation or self harm) will be reported to their GP, followed up by a letter.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-operative length of hospital stay
Time Frame: up to 1 year
Date of hospital admission minus date of discharge would equal length of post-operative stay (LOS).
up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in objectively measured cardiopulmonary exercise testing variables - Oxygen uptake at anaerobic threshold (ml/kg/min) and oxygen uptake at peak exercise (ml/kg/min)
Time Frame: up to 15 weeks
Change in cardiopulmonary exercise variables i.e. oxygen uptake (VO2) at anaerobic threshold (AT) and at peak exercise. A clinically significant difference in physical fitness is defined as ≥ 2ml/min/kg VO2 at AT.
up to 15 weeks
Overall survival - 1
Time Frame: 1 year post-operatively
Overall survival at 1 year post surgery
1 year post-operatively
Overall survival -2
Time Frame: 5 years post-operatively
Overall survival at 5 year post surgery
5 years post-operatively
Disease free survival
Time Frame: 1 year post-operatively
Clinical or radiologically measured disease free survival
1 year post-operatively
Post-operative morbidity -1
Time Frame: POMS at day 3,5,7 and 15.
Patients post-operative morbidity survey (POMS) will be characterised on day 3, 5, 7 and 15. The POMS 18-item survey will be used to address nine domains of postoperative morbidity (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound complication, haematological and pain).
POMS at day 3,5,7 and 15.
Post-operative morbidity -2
Time Frame: up to 1 year
On day of discharge, patient's surgical complications (if any) will be graded using the Clavien-Dindo classification of surgical complications This classification is used to assess overall hospital morbidity following surgical procedures. Patients are graded as 0 (no complications) or Grade I-V based on the level of complication, including the number of organ system involvement. Grade V is defined as death of a patient. A record of the Comprehensive Complication Index (CCI) - an update of the Clavien-Dindo classification will also be collected
up to 1 year
Physical activity -1
Time Frame: Baseline up to 1 year post-operatively
Number of steps while active using a triaxial accelerometer eg. Senseware
Baseline up to 1 year post-operatively
Physical activity -2
Time Frame: Baseline up to 1 year post-operatively
sleep efficiency using a triaxial accelerometer eg. Senseware
Baseline up to 1 year post-operatively
Physical activity -3
Time Frame: Baseline up to 1 year post-operatively
metabolic equivalents using a triaxial accelerometer eg. Senseware
Baseline up to 1 year post-operatively
Physical activity -4
Time Frame: Baseline up to 1 year post-operatively
Godin Leisure Time and Exercise questionnaire - A self-reported measure of physical activity
Baseline up to 1 year post-operatively
Health related quality of life -1
Time Frame: Baseline up to 1 year post-operatively

Changes in health related quality of life measurements using validated questionnaires; including:

EQ-5D-5L is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys
Baseline up to 1 year post-operatively
Health related quality of life -2
Time Frame: Baseline up to 1 year post-operatively

Changes in health related quality of life measurements using validated questionnaires; including:

Cancer specific quality of life will be measured using the EORTC-QLQ-C30.
Baseline up to 1 year post-operatively
Health related quality of life -3
Time Frame: Baseline up to 1 year post-operatively
Changes in health related quality of life measurements using validated semi-structured interview techniques
Baseline up to 1 year post-operatively
Mental well being -1
Time Frame: Baseline up to 1 year post-operatively

Self-efficacy (confidence) to self-manage chronic disease (SEMCD), measured using the Lorig SEMCD scale

A confidence scale that represents the patients confidence that a regular task can be achieved. 1 = Not confident at all and 10= totally confident.
Baseline up to 1 year post-operatively
Mental well being -2
Time Frame: Baseline up to 1 year post-operatively

Patients knowledge skills and confidence to manage their own health and care will be measured using the Patient Activation Measure (PAM)

Agreement or disagreement with statements. Choice between disagree strongly, disagree, agree, agree strongly and not applicable
Baseline up to 1 year post-operatively
Mental well being -3
Time Frame: Baseline up to 1 year post-operatively

Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale (HADS)

A tick box questionnaire relating to anxieties and depression that a patient might have felt over the past week. Choices are most of the time, a lot fo the time, from time to time, and not at all for most questions.
Baseline up to 1 year post-operatively
Mental well being -4
Time Frame: Baseline up to 1 year post-operatively

Resilience, measured using the Connor-Davidson Resilience Scale (CD-RISC2)

Patients are asked to choose "x" in a box that best indicates how much they agree with the following statements resilience over the past month.

Options are not at all true; rarely true; sometimes true; often true; true nearly all of the time
Baseline up to 1 year post-operatively
Mental well being -5
Time Frame: Baseline up to 1 year post-operatively

Brief illness perception questionnaire (B-IPQ) - A self- reported nine-item scale designed to rapidly assess the cognitive and emotional representations of illness by a questionnaire.

Various illness questions are asked and the patient picks a number from 0 to 10; 0= no affect at all and 10= severely affects my life.
Baseline up to 1 year post-operatively
Complex health interventions evaluation
Time Frame: Baseline up to 1 year post-operatively
Medical research council (MRC) RE-AIM reporting
Baseline up to 1 year post-operatively
Radiological markers of sarco-cachexia measured from routine CT scans
Time Frame: Baseline up to 1 year post-operatively
CT, MRI, PET CT full report from radiologist including TNM stage, venous invasion, resection margin involvement, tumour metabolic activity, RECIST staging and any other cancer pathway specific staging/restaging test. Raw DICOM files from radiological softwares or via the PACS team will be downloaded securely to measure radiological markers of sarco-cachexia.
Baseline up to 1 year post-operatively
Toxicity and adverse events
Time Frame: Baseline up to 1 year post-operatively
Neoadjuvant cancer therapy induced toxicity measured using the CTC AE v4
Baseline up to 1 year post-operatively
Tumour outcomes -1
Time Frame: Baseline up to 1 year post-operatively
Radiology - CT, MRI, PET CT - Tumour Node Metastasis (TNM v7) stage
Baseline up to 1 year post-operatively
Tumour outcomes -2
Time Frame: Baseline up to 1 year post-operatively
Radiology - CT, MRI, PET CT full report from radiologist mainly including venous invasion
Baseline up to 1 year post-operatively
Tumour outcomes -3
Time Frame: Baseline up to 1 year post-operatively
Radiology - CT, MRI, PET CT full report from radiologist mainly including resection margin involvement
Baseline up to 1 year post-operatively
Tumour outcomes -4
Time Frame: Baseline up to 1 year post-operatively
Radiology - CT, MRI, PET CT full report from radiologist mainly including tumour metabolic activity
Baseline up to 1 year post-operatively
Tumour outcomes -5
Time Frame: Baseline up to 1 year post-operatively
Radiology - CT, MRI, PET CT full report from radiologist mainly including RECIST staging
Baseline up to 1 year post-operatively
Tumour outcomes -6
Time Frame: Baseline up to 1 year post-operatively
Radiology - CT, MRI, PET CT full report from radiologist mainly including tumour regression score
Baseline up to 1 year post-operatively
Tumour outcomes -7
Time Frame: Baseline up to 1 year post-operatively
Histopathology - TNM score version 7
Baseline up to 1 year post-operatively
Tumour outcomes -8
Time Frame: Baseline up to 1 year post-operatively
Histopathology - differentiation grading using TNM version 7
Baseline up to 1 year post-operatively
Tumour outcomes -9
Time Frame: Baseline up to 1 year post-operatively
Histopathology - extramural tumour extension using TNM version 7
Baseline up to 1 year post-operatively
Tumour outcomes -10
Time Frame: Baseline up to 1 year post-operatively
Histopathology - lymphovascular invasion using TNM version 7
Baseline up to 1 year post-operatively
Tumour outcomes -11
Time Frame: Baseline up to 1 year post-operatively
Histopathology - perineural invasion using TNM version 7
Baseline up to 1 year post-operatively
Tumour outcomes -12
Time Frame: Baseline up to 1 year post-operatively
Histopathology - venous invasion using TNM version 7
Baseline up to 1 year post-operatively
Tumour outcomes -13
Time Frame: Baseline up to 1 year post-operatively
Histopathology -resection margin status using TNM version 7
Baseline up to 1 year post-operatively
Tumour outcomes -14
Time Frame: Baseline up to 1 year post-operatively
Histopathology - tumour regression grading (TRG/ Mandard Score)
Baseline up to 1 year post-operatively
Tumour outcomes -15
Time Frame: Baseline up to 1 year post-operatively
Histopathology -lymph node status using TNM version 7
Baseline up to 1 year post-operatively
Tumour outcomes -16
Time Frame: Baseline up to 1 year post-operatively
Histopathology - number of lymph nodes involved using TNM version 7
Baseline up to 1 year post-operatively
Disability adjusted survival
Time Frame: Baseline up to 1 year post-operatively
WHODAS v2.0 will ask patients to rate whether their health condition has had impact upon them in regards to 7 disability and functionality domains (understanding and communicating, getting around, self-care, getting along with others, life activities: household, life activities: work/school, and participation in society). This includes a measure of cost effectiveness.
Baseline up to 1 year post-operatively
Tumour microenvironment
Time Frame: Baseline up to 1 year post-operatively

Endoscopic and surgical paired tumour biopsies will be taken as part of the oesophageal cancer clinical and molecular stratification study (OCCAMS) if the patient has been consented to the bio-banking study. Endoscopic and surgical paired tumour biopsies will be taken as part of TARGET LUNG study if the patient has been consented to the bio-banking study. Other tumor types will be banked in centers taking part in the International Cancer Genome Consortium. Clinical cancer pathway pathological samples embedded in paraffin and used in routine clinical practice may also be requested at a later stage for tumour analyses.

Tumour biopsy +/- at endoscopic ultrasound (pre Cancer treatments and upon diagnosis) and at surgery (where possible depending on availability at site and cancer cohort)
Baseline up to 1 year post-operatively
Nutrition -1
Time Frame: Baseline up to 1 year post-operatively
Height (cms) and weight (kg) will be combined to report BMI in kg/m^2
Baseline up to 1 year post-operatively
Nutrition -2
Time Frame: Baseline up to 1 year post-operatively
Patient Reported Experience Measures (PREMS) including symptom and appetite questionnaires (Council of Nutrition Appetite Questionnaire- CNAQ) (in My Medical Record as part of standard clinical care)
Baseline up to 1 year post-operatively
Nutrition -3
Time Frame: Baseline up to 1 year post-operatively
Patient self-completing online assessment (myFood24 incorporated in My Medical Record)
Baseline up to 1 year post-operatively
Nutrition -4
Time Frame: Baseline up to 1 year post-operatively
Malnutrition Universal Screening Tool as part of standard clinical care
Baseline up to 1 year post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital Southampton NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Portsmouth Hospitals NHS Trust
Hampshire Hospitals NHS Foundation Trust
Poole Hospital NHS Foundation Trust
Isle of Wight NHS Trust
Dorset County Hospital NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Samantha Leggett, University Hospitals Southampton NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RHM CRI 0360

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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