Colorectal CancerPhase 2NCT02581059
Efficacy of Ginseng for Patients on Regorafenib
A Phase 2 study testing Regorafenib and Ginseng in people with Colorectal Cancer and Palliative Medicine, run by Wake Forest University Health Sciences at 5 sites in United States.
Trial summary
This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Palliative Medicine, Supportive Care
- What is being tested?
- Regorafenib and Ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2016to 22 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must be able to understand and be willing to sign the written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. A signed informed consent form (ICF) must be appropriately obtained prior to the conduct of any trial-specific procedure. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- Life expectancy of at least 12 weeks (3 months) as determined by the treating physician.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 28 days prior to registration.
- Histological or pathologically confirmed stage IV adenocarcinoma of the colon.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
Show all 10Show fewer
- Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 2 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the treating physician or a designated associate. NOTE: Examples of adequate contraception may include but are not limited to a combination of any two of the following: use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/ film/cream/vaginal suppository); total abstinence; male/female sterilization
- All subjects must have radiographically assessable disease per RECIST v1.1 obtained by imaging within 28 days prior to registration.
- Must be able to swallow and retain oral medication.
- Subject must be deemed a suitable candidate for regorafenib as per their treating physician.
Who cannot join
- Subject should not be receiving any agent for fatigue including steroids, megace or opioids. NOTE: Subjects who have a contrast-induced allergy are allowed to receive steroids for their scans.
- Radiotherapy within 2 weeks prior to study registration. Subjects must have recovered from all therapy-related toxicities.
- Prior treatment with regorafenib.
- Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
- Congestive heart failure > New York Heart Association (NYHA) class 2: unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before study registration; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
- Evidence or history of bleeding diathesis or coagulopathy.
Show all 27Show fewer
- Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to study registration.
- Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 months of study registration.
- Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 3 years prior to randomization EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (Non-invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].
- Subjects with pheochromocytoma.
- Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
- Ongoing infection > Grade 2 NCI-CTCAE v4.0.
- Metastatic brain or meningeal tumors (symptomatic or asymptomatic).
- Major surgical procedure or significant traumatic injury, as defined by the site investigator, within 28 days before study registration.
- Renal failure requiring hemo- or peritoneal dialysis
- Dehydration Grade > 2 NCI CTCAE v4 within 7 days prior to registration.
- Subjects with seizure disorder currently requiring medication.
- Persistent proteinuria ≥ Grade 3 NCI CTCAE v4.0 as defined as > 3.5 g/24 hours, measured by urine protein: creatinine ratio on a random urine sample.
- Interstitial lung disease with ongoing signs and symptoms at the time of study registration.
- Pleural effusion or ascites that causes respiratory compromise (≥ NCI CTCAE version 4.0 Grade 2 dyspnea).
- History of organ allograft (including corneal transplant).
- Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial.
- Any malabsorption condition which, in the opinion of the treating physician, will affect the absorption of any of the agents used in this study.
- Women who are pregnant or breast-feeding.
- Any condition, which, in the site investigator's opinion, makes the subject unsuitable for trial participation.
- Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
- Treatment with any investigational agent within 28 days prior to registration.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Indiana Univeristy Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, 46219
Altantic Health System
Morristown, New Jersey, 07960
Comprehensive Cancer Center at Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: A Randomized Phase II Trial to Evaluate the Efficacy of Supportive Therapy With Ginseng for Patients on Treatment With Regorafenib
This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.
Read the detailed description
OUTLINE: This is a multi-center study.
INVESTIGATIONAL TREATMENT:
Regorafenib will be administered 160 mg orally once daily for the first 21 days of each 28-day cycle. Subjects that randomize to receive ginseng will take 1,000 mg orally twice daily every day for 4 weeks (2 cycles). Subjects that randomize to NOT receive ginseng will not be given ginseng. Subjects will be instructed to take regorafenib with a low-fat meal.
Subjects will undergo fatigue assessments, using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument and Patient-Reported Outcomes Measurement Information System (PROMIS). Subjects will have a pill count cycle 2 day 1 (C2D1) and at the end of treatment visit. Subjects will have the re-staging scan (CT of chest/abdomen/pelvis) at the end of Cycle 2/ week 8 (±5).
Adequate bone marrow, liver and renal function assessed by the following laboratory values obtained within 7 days prior to registration for protocol therapy:
Hematopoietic:
- Absolute neutrophil count (ANC) count > 1,500/mm^3
- Hemoglobin (Hgb) > 9g/dL
- Platelet count > 100,000/mm^3
Renal:
- Serum creatinine ≤ 1.5 × the upper limit of normal (ULN)
Hepatic:
- Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
- Alkaline phosphatase (ALP) limit ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
Coagulation:
- International normalized ratio (INR)/Partial thromboplastin time (PTT) ≤ 1.5 × ULN. NOTE: Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable, based on a measurement that is pre-dose as defined by the local standard of care. Warfarin does should not exceed 1 mg.
- Conditions
- Colorectal Cancer, Palliative Medicine, Supportive Care
- Being tested
- Regorafenib, Ginseng
- Keywords
- Regorafenib, American Ginseng, Fatigue
- Medical subject headings
- Colorectal Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
Also called Stivarga
All subjects will receive regorafenib 160 mg orally once daily for the first 21 days of each 28-day cycle for 2 cycles.
GinsengDietary supplement
Also called Panax quinquefolius
Subjects randomized to ginseng will receive 1,000 mg orally twice every day of each 28-day cycle for 2 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib + Ginseng | Experimental | Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle. Subjects will receive 1,000 mg ginseng orally twice daily every day for 4 weeks (2 cycles). Receives: Drug: Regorafenib; Dietary Supplement: Ginseng |
| Regorafenib Only | Active comparator | Regorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle for 2 cycles. Receives: Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Fatigue Assessment--Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
MFSI-SF is a 30-item self-report instrument designed to measure general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor--each scored on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely"). The total score is calculated by adding the general, physical, emotional, and mental subscale scores and subtracting the vigor subscale score. Thus, total scores can range from -24 to 96 where higher scores indicate more of the cancer-related fatigue (meaning higher scores represent worse fatigue). A minimally clinically important improvement (or worsening) in the MFSI-Short Form is for changes of more than 4.5 points. T-score value of 36 indicates the population mean with a standard deviation of 34.93.
Measured: From date of first dose until end of cycle 2 (8 weeks)
Subject Fatigue Assessment--Patient-Reported Outcomes Measurement Information System (PROMIS)
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Each of the total raw scores were translated into T-scores for each participant using scoring tables for converting the PROMIS short form. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For this instrument all questions were negatively worded (i.e., How fatigued were you on average?) therefore a higher T-score represents having more fatigue. Thus, a T-score of 60 is one SD
Measured: From date of first dose until end of cycle 2 (8 weeks)
Secondary outcomes (8)
Subject Compliance
Pill counts will be used to assess adherence to regorafenib and ginseng for subjects on each arm. Overall percentage reported.
Measured: Cycle 1 From date of first dose until day 15
Subject Compliance
Pill counts will be used to assess adherence to regorafenib and ginseng for subjects on each arm. Overall percentage reported.
Measured: Cycle 2 From date of first dose until day 15
Subject Compliance
Pill counts will be used to assess adherence to regorafenib and ginseng for subjects on each arm. Overall percentage reported.
Measured: Cycle 1 From day16 until day 22
Subject Compliance
Pill counts will be used to assess adherence to regorafenib and ginseng for subjects on each arm. Overall percentage reported.
Measured: Cycle 2 From day 16 until day 22
Characterize Adverse Events (AE)
Toxicity assessed using Common Terminology Criteria for Adverse Events v4.0 (CTCAE v4.0) criteria
Measured: From date of first dose until end of cycle 2 (8 weeks)
Subject Retention
Retention will be determined by the proportion of subjects on each arm who complete the study.
Measured: From date of first dose until end of cycle 2 (8 weeks)
Evaluate Response Rate (RR)
the number of subjects with confirmed partial response (PR) or complete response (CR) according to RECIST v.1.1, from the start of treatment until disease progression/recurrence
Measured: From cycle 1 day 1 (C1D1) until death or up to 18 months
Number of Participants With Overall Survival
date of randomization to date of death from any cause
Measured: From C1D1 until death or up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study startApr 2016
- Primary completion22 Jun 2018
- Study completion22 Jun 2018
Why it stopped: Funder terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Hoosier Cancer Research Network
- Responsible party
- Sponsor
- Investigators
- Rodwige J. Desnoyers, M.D., Study chair, Hoosier Cancer Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581059
- Sponsor's protocol ID
- IRB00035502
- Other IDs
- HCRN GI14-191
- Status last verified
- Sep 2022
- First submitted
- 16 Oct 2015
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial to Evaluate the Efficacy of Supportive Therapy With Ginseng for Patients on Treatment With Regorafenib
- ClinicalTrials.gov ID
- NCT02581059
- Acronym / sponsor ID
- IRB00035502
- Conditions
- Colorectal Cancer, Palliative Medicine, Supportive Care
- Keywords
- Regorafenib, American Ginseng, Fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funder terminated.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Bayer, Hoosier Cancer Research Network
- Study start
- Apr 2016
- Primary completion
- 22 Jun 2018 (actual)
- Study completion
- 22 Jun 2018 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multi-center phase II study of ginseng in colorectal cancer patients treated with regorafenib to determine if ginseng will reduce fatigue in this patient population and improve adherence to regorafenib. Ninety (90) subjects will be enrolled and randomized using a 2:1 allocation, with 60 subjects enrolled in the regorafenib + ginseng group and 30 enrolled in the regorafenib + no ginseng group.
Detailed description
OUTLINE: This is a multi-center study.
INVESTIGATIONAL TREATMENT:
Regorafenib will be administered 160 mg orally once daily for the first 21 days of each 28-day cycle. Subjects that randomize to receive ginseng will take 1,000 mg orally twice daily every day for 4 weeks (2 cycles). Subjects that randomize to NOT receive ginseng will not be given ginseng. Subjects will be instructed to take regorafenib with a low-fat meal.
Subjects will undergo fatigue assessments, using the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) instrument and Patient-Reported Outcomes Measurement Information System (PROMIS). Subjects will have a pill count cycle 2 day 1 (C2D1) and at the end of treatment visit. Subjects will have the re-staging scan (CT of chest/abdomen/pelvis) at the end of Cycle 2/ week 8 (±5).
Adequate bone marrow, liver and renal function assessed by the following laboratory values obtained within 7 days prior to registration for protocol therapy:
Hematopoietic:
- Absolute neutrophil count (ANC) count > 1,500/mm^3
- Hemoglobin (Hgb) > 9g/dL
- Platelet count > 100,000/mm^3
Renal:
- Serum creatinine ≤ 1.5 × the upper limit of normal (ULN)
Hepatic:
- Total bilirubin ≤ 1.5 × the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
- Alkaline phosphatase (ALP) limit ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver involvement of their cancer)
Coagulation:
- International normalized ratio (INR)/Partial thromboplastin time (PTT) ≤ 1.5 × ULN. NOTE: Subjects who are prophylactically treated with an agent such as warfarin or heparin will be allowed to participate if no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable, based on a measurement that is pre-dose as defined by the local standard of care. Warfarin does should not exceed 1 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regorafenib + Ginseng | Experimental | Drug: Regorafenib, Dietary Supplement: GinsengRegorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle. Subjects will receive 1,000 mg ginseng orally twice daily every day for 4 weeks (2 cycles). |
| Regorafenib Only | Active comparator | Drug: RegorafenibRegorafenib will be administered 160 mg once daily for the first 21 days of each 28-day cycle for 2 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects must be able to understand and be willing to sign the written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information. A signed informed consent form (ICF) must be appropriately obtained prior to the conduct of any trial-specific procedure. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age ≥ 18 years at the time of consent.
- Life expectancy of at least 12 weeks (3 months) as determined by the treating physician.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 28 days prior to registration.
- Histological or pathologically confirmed stage IV adenocarcinoma of the colon.
Key exclusion criteria (27 listed)
- Subject should not be receiving any agent for fatigue including steroids, megace or opioids. NOTE: Subjects who have a contrast-induced allergy are allowed to receive steroids for their scans.
- Radiotherapy within 2 weeks prior to study registration. Subjects must have recovered from all therapy-related toxicities.
- Prior treatment with regorafenib.
- Previous assignment to treatment during this study. Subjects permanently withdrawn from study participation will not be allowed to re-enter study.
- Congestive heart failure > New York Heart Association (NYHA) class 2: unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), myocardial infarction less than 6 months before study registration; cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted); uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
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 |
|---|---|---|
| RegorafenibAlso: StivargaAll subjects will receive regorafenib 160 mg orally once daily for the first 21 days of each 28-day cycle for 2 cycles. | Drug | Regorafenib + Ginseng, Regorafenib Only |
| GinsengAlso: Panax quinquefoliusSubjects randomized to ginseng will receive 1,000 mg orally twice every day of each 28-day cycle for 2 cycles. | Dietary supplement | Regorafenib + Ginseng |
Primary outcome
Subject Fatigue Assessment--Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
Time frame: From date of first dose until end of cycle 2 (8 weeks)
MFSI-SF is a 30-item self-report instrument designed to measure general fatigue, physical fatigue, emotional fatigue, mental fatigue, and vigor--each scored on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely"). The total score is calculated by adding the general, physical, emotional, and mental subscale scores and subtracting the vigor subscale score. Thus, total scores can range from -24 to 96 where higher scores indicate more of the cancer-related fatigue (meaning higher scores represent worse fatigue). A minimally clinically important improvement (or worsening) in the MFSI-Short Form is for changes of more than 4.5 points. T-score value of 36 indicates the population mean with a standard deviation of 34.93.
Subject Fatigue Assessment--Patient-Reported Outcomes Measurement Information System (PROMIS)
Time frame: From date of first dose until end of cycle 2 (8 weeks)
PROMIS is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Each of the total raw scores were translated into T-scores for each participant using scoring tables for converting the PROMIS short form. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore, a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For this instrument all questions were negatively worded (i.e., How fatigued were you on average?) therefore a higher T-score represents having more fatigue. Thus, a T-score of 60 is one SD
8 secondary outcomes
Subject Compliance
Time frame: Cycle 1 From date of first dose until day 15
Subject Compliance
Time frame: Cycle 2 From date of first dose until day 15
Subject Compliance
Time frame: Cycle 1 From day16 until day 22
Subject Compliance
Time frame: Cycle 2 From day 16 until day 22
Characterize Adverse Events (AE)
Time frame: From date of first dose until end of cycle 2 (8 weeks)
Subject Retention
Time frame: From date of first dose until end of cycle 2 (8 weeks)
Evaluate Response Rate (RR)
Time frame: From cycle 1 day 1 (C1D1) until death or up to 18 months
Number of Participants With Overall Survival
Time frame: From C1D1 until death or up to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Hoosier Cancer Research Network WebsiteLink provided by the sponsor.
- 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.
Rodwige J. Desnoyers, M.D. study chair
Hoosier Cancer Research Network
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regorafenib and Ginseng in people with Colorectal Cancer and Palliative Medicine, run by Wake Forest University Health Sciences at 5 sites 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 10 inclusion and 27 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Subject Fatigue Assessment--Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF) (time frame: From date of first dose until end of cycle 2 (8 weeks)). The study lists 2 primary outcomes in all. 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 26 Jun 2024.