Advanced Malignant Solid NeoplasmPhase 2/3NCT03927885
Open Labeled Placebo in Reducing Cancer Related Fatigue in Patients With Advanced Cancer
A Phase 2/3 study testing Quality-of-Life Assessment, Questionnaire Administration and Waiting List in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II/III trial studies an open labeled placebo to see how well it works compared with waitlist control in reducing cancer related fatigue in patients with cancer that has spread to other places in the body. A placebo is not a drug and is not designed to treat any disease or illness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Waiting List
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2019to 31 Dec 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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
- Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors)
- Presence of fatigue of >= 4/10 on Edmonton Symptom Assessment System (ESAS) Fatigue item (0-10 severity scale)
- Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
- Uncontrolled pain; patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (> 25%) for at least 48 hours prior to study entry. Change in opioid dose after study entry is allowed
- Patient must be 18 years of age or older. The questionnaires used in this study have been validated only in the adult population
- Patient must be willing to engage in telephone follow up with research staff
- Patient must have telephone access to be contacted by the research staff
- Hemoglobin level of >= 8 g/dL. Patient may receive packed red blood cell (PRBC) transfusion so as to have hemoglobin level of >= 8 g/dL so at participate in the study
Who cannot join
- Surgery, or pain relieving procedures within 2 weeks of entry into the study or during the study period
- Patients with history of substance abuse (Cut down, Annoyed, Guilty, Eye opener [CAGE] >= 2+), cognitively impaired (MD Anderson Symptom [MDAS] > 7)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer
This phase II/III trial studies an open labeled placebo to see how well it works compared with waitlist control in reducing cancer related fatigue in patients with cancer that has spread to other places in the body. A placebo is not a drug and is not designed to treat any disease or illness. Recent studies have found that cancer related fatigue symptoms in cancer survivors are improved with open labeled placebo (that is, patients know they are taking a placebo). It is not yet known how well an open labeled placebo works when compared with waitlist control in reducing cancer related fatigue.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine the effects of open labeled placebo one tablet twice a day (OLP) compared to waitlist control (WLC) for reducing cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale in fatigued advanced cancer patients at the end of one week.
SECONDARY OBJECTIVES:
- To determine the preliminary efficacy open labeled placebo (OLP) and WLC on various fatigue dimensions - (Multidimensional Fatigue Symptom Inventory, MFSI-SF), depression (The Center for Epidemiologic Studies - Depression [CES-D]), cancer symptoms (Edmonton Symptom Assessment System [ESAS]), function and strength (six minute walk test, and 30-sec chair stand test), Global Symptom Evaluation (GSE), and quality of life (Functional Assessment of Cancer Therapy - General [FACT-G]) in these advanced cancer patients.
II. To determine effects of OLP on fatigue symptom composite score (ESAS fatigue, pain and depression) at the end of 1st and 4th week.
III. To examine the adherence and safety for the OLP as treatment for cancer related fatigue.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive open labeled placebo orally (PO) twice daily (BID) for 4 weeks in the absence of disease progression.
ARM II: Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Being tested
- Placebo Administration, Quality-of-Life Assessment, Questionnaire Administration, Waiting List
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo AdministrationOther
Given open labeled placebo PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Waiting ListOther
Also called Waitlist
Assigned to a waiting list
| Study group | Role | What they receive |
|---|---|---|
| Arm I (open labeled placebo) | Experimental | Patients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression. Receives: Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
| Arm II (waiting list, open labeled placebo) | Active comparator | Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression. Receives: Other: Placebo Administration; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Other: Waiting List |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cancer related fatigue
Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups.
Measured: Baseline up to 1 week
Secondary outcomes (9)
Change in quality of life (QOL)
Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups. The percentage of patients who report 'better' in each group will be reported. Will also compare the % of patients who report 'somewhat better' to "a great deal better" in each group and report the difference between groups (chi-square tests).
Measured: Baseline up to 4 weeks
Change in function strength
Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups. The percentage of patients who report 'better' in each group will be reported. Will also compare the % of patients who report 'somewhat better' to "a great deal better" in each group and report the difference between groups (chi-square tests).
Measured: Baseline up to 4 weeks
Change in Global Symptom Evaluation (GSE)
Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups. The percentage of patients who report 'better' in each group will be reported. Will also compare the % of patients who report 'somewhat better' to "a great deal better" in each group and report the difference between groups (chi-square tests).
Measured: Baseline up to 4 weeks
Changes in cluster composite scores of sleep disturbance
The primary comparison will be using changes in cluster composite scores of sleep disturbance from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.
Measured: Baseline up to 1 week
Changes in cluster composite scores of fatigue
The primary comparison will be using changes in cluster composite scores of fatigue from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.
Measured: Baseline up to 1 week
Changes in cluster composite scores of pain
The primary comparison will be using changes in cluster composite scores of pain from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.
Measured: Baseline up to 1 week
Changes in cluster composite scores of depression
The primary comparison will be using changes in cluster composite scores of depression from baseline to end of week 1 between the placebo arm and waitlist control arm. Exploratory graphical analysis of the data will be done. If the assumptions of the t-test are violated, will use the Wilcoxon rank sum test.
Measured: Baseline up to 1 week
Adherence
Will use a chi-square to test the difference in adherence between each placebo group versus waitlist control group.
Measured: Up to 4 weeks
Incidence of adverse events
Will calculate the chi-square statistic to test the difference in adverse events between placebo group versus waitlist control group.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start30 Mar 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sriram Yennu, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927885
- Sponsor's protocol ID
- 2018-0526
- Other IDs
- NCI-2019-01027, 2018-0526
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2019
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Labeled Placebo for Treatment of Cancer Related Fatigue in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03927885
- Acronym / sponsor ID
- 2018-0526
- Conditions
- Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Mar 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2019 (actual)
- 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.
This phase II/III trial studies an open labeled placebo to see how well it works compared with waitlist control in reducing cancer related fatigue in patients with cancer that has spread to other places in the body. A placebo is not a drug and is not designed to treat any disease or illness. Recent studies have found that cancer related fatigue symptoms in cancer survivors are improved with open labeled placebo (that is, patients know they are taking a placebo). It is not yet known how well an open labeled placebo works when compared with waitlist control in reducing cancer related fatigue.
Detailed description
PRIMARY OBJECTIVE:
- To determine the effects of open labeled placebo one tablet twice a day (OLP) compared to waitlist control (WLC) for reducing cancer-related fatigue (CRF) as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale in fatigued advanced cancer patients at the end of one week.
SECONDARY OBJECTIVES:
- To determine the preliminary efficacy open labeled placebo (OLP) and WLC on various fatigue dimensions - (Multidimensional Fatigue Symptom Inventory, MFSI-SF), depression (The Center for Epidemiologic Studies - Depression [CES-D]), cancer symptoms (Edmonton Symptom Assessment System [ESAS]), function and strength (six minute walk test, and 30-sec chair stand test), Global Symptom Evaluation (GSE), and quality of life (Functional Assessment of Cancer Therapy - General [FACT-G]) in these advanced cancer patients.
II. To determine effects of OLP on fatigue symptom composite score (ESAS fatigue, pain and depression) at the end of 1st and 4th week.
III. To examine the adherence and safety for the OLP as treatment for cancer related fatigue.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive open labeled placebo orally (PO) twice daily (BID) for 4 weeks in the absence of disease progression.
ARM II: Patients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (open labeled placebo) | Experimental | Other: Placebo Administration, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive open labeled placebo PO BID for 4 weeks in the absence of disease progression. |
| Arm II (waiting list, open labeled placebo) | Active comparator | Other: Placebo Administration, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Waiting ListPatients are assigned to a waiting list during week 1. Beginning in week 2, patients receive open labeled placebo PO BID for 3 weeks in the absence of disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors)
- Presence of fatigue of >= 4/10 on Edmonton Symptom Assessment System (ESAS) Fatigue item (0-10 severity scale)
- Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
- Uncontrolled pain; patient is on opioids for the treatment of cancer pain, he/she must have had no major dose change (> 25%) for at least 48 hours prior to study entry. Change in opioid dose after study entry is allowed
- Patient must be 18 years of age or older. The questionnaires used in this study have been validated only in the adult population
Key exclusion criteria (2 listed)
- Surgery, or pain relieving procedures within 2 weeks of entry into the study or during the study period
- Patients with history of substance abuse (Cut down, Annoyed, Guilty, Eye opener [CAGE] >= 2+), cognitively impaired (MD Anderson Symptom [MDAS] > 7)
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 |
|---|---|---|
| Placebo AdministrationGiven open labeled placebo PO | Other | Arm I (open labeled placebo), Arm II (waiting list, open labeled placebo) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Arm I (open labeled placebo), Arm II (waiting list, open labeled placebo) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (open labeled placebo), Arm II (waiting list, open labeled placebo) |
| Waiting ListAlso: WaitlistAssigned to a waiting list | Other | Arm II (waiting list, open labeled placebo) |
Primary outcome
Change in cancer related fatigue
Time frame: Baseline up to 1 week
Will use t-tests to assess the mean changes and standard deviations from baseline to follow-up between the groups.
9 secondary outcomes
Change in quality of life (QOL)
Time frame: Baseline up to 4 weeks
Change in function strength
Time frame: Baseline up to 4 weeks
Change in Global Symptom Evaluation (GSE)
Time frame: Baseline up to 4 weeks
Changes in cluster composite scores of sleep disturbance
Time frame: Baseline up to 1 week
Changes in cluster composite scores of fatigue
Time frame: Baseline up to 1 week
Changes in cluster composite scores of pain
Time frame: Baseline up to 1 week
Changes in cluster composite scores of depression
Time frame: Baseline up to 1 week
Adherence
Time frame: Up to 4 weeks
Incidence of adverse events
Time frame: Up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Sriram Yennu principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Quality-of-Life Assessment, Questionnaire Administration and Waiting List in people with Advanced Malignant Solid Neoplasm and Metastatic Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 in cancer related fatigue (time frame: Baseline up to 1 week). 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 11 Aug 2026.