Advanced Malignant Solid NeoplasmPhase 2NCT03035409
Anamorelin Hydrochloride, Physical Activity, and Nutritional Counseling in Decreasing Cancer-Related Fatigue in Patients With Incurable Metastatic or Recurrent Solid Tumors
A Phase 2 study testing Anamorelin Hydrochloride, Exercise Intervention and Laboratory Biomarker Analysis in people with Advanced Malignant Solid Neoplasm and C-Reactive Protein Measurement, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, C-Reactive Protein Measurement, Cancer Fatigue
- What is being tested?
- Anamorelin Hydrochloride, Exercise Intervention and Laboratory Biomarker Analysis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2017to 28 Feb 2028
- 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
- Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
- Presence of fatigue on FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
- Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
- CRP must be >= 3 mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
- No evidence of moderate to severe depression as determined by a HADS depression score of =< 13
- Presence of unintentional weight loss ranging from >= 2 - =< 15% in last 12 months
Show all 12Show fewer
- Uncontrolled pain; if 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; the dose of morphine equivalent daily should not exceed 120 mg/day unless approved by the principal investigator (PI); change in opioid dose after study entry is allowed
- 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 >= 9 g/dL
- Estimated life expectancy of > 4 months at the time of screening
- Aspartate transaminase (AST) and alanine transaminase (ALT) levels =< 5 x upper limit of normal (ULN)
Who cannot join
- Major contraindications to anamorelin e.g. hypersensitivity
- Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a week
- Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
- Pregnant or lactating women, childbearing age women who are not on birth control; negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications: women who are able to become pregnant must use birth control during the study and for 30 days after the last anamorelin dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
- Uncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screening
- Male patients with a history of untreated hypogonadism
Show all 11Show fewer
- Patients on drugs with strong CYP 3A4 inhibitors within the previous two weeks (ketoconazole, clarithromycin, itraconazole, nefazodone, telithromycin)
- Patients on drugs that may prolong the PR or QRS interval durations, such as any of the class I/sodium (Na+) channel blocking antiarrhythmic medications should be avoided (e.g. flecainide, procainamide, propafenone, quinidine)
- Patients with untreated clinically relevant hypothyroidism
- Patients currently on investigational therapies will be evaluated by the PI on a case by case basis and study participation approval will be obtained from the treating oncologist
- Patients with prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Anamorelin on Cancer-Related-Fatigue in Patients With Advanced Cancer
This phase II trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate changes in the Functional Assessment of Cancer Illness Therapy-Fatigue (FACIT-F) subscale score at day 43 +/- 3 days compared to baseline in patients with advanced cancer receiving oral anamorelin hydrochloride (anamorelin) 100 mg daily and standardized physical activity and nutritional counseling.
SECONDARY OBJECTIVES:
- To examine the effects of anamorelin and standardized physical activity and nutritional counseling on health-related quality of life and patient reported outcomes as measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Patient Reported Outcomes Measurement Information System (PROMIS) - Fatigue, Hospital Anxiety Depression Scale (HADS), Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Cancer Therapy (FACT-G) and its Functional Assessment of Anorexia/Cachexia Treatment (FAACT) subscale in these patients.
II. To examine the side effects and tolerability of anamorelin in these patients.
EXPLORATORY OBJECTIVES:
- To explore the effects of anamorelin and standardized physical activity and nutritional counseling on muscle function (as measured by the 30 second chair stand test, 6 minute walk test, day time activity [accelerometer], body composition [as measured by INBODY], and resting energy expenditure [measured by indirect calorimetry]).
II. To characterize the effects of anamorelin on potential inflammatory biomarkers of cancer-related fatigue (CRF) (C-Reactive Protein [CRP], monocyte IL-6\&R, TNF-a\&R, IL-10, IL-8, IL-1\&RA; IGF-1).
III. To explore the effects of anamorelin on sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).
IV. To determine the association between change in FACIT-F scores and changes in muscle function, day time activity, and body composition, in patients with advanced cancer receiving oral anamorelin 100 mg daily and standardized physical activity and nutritional counseling.
OUTLINE:
Patients receive anamorelin hydrochloride orally (PO) once daily (QD) and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
After completion of study treatment, patients are followed up on day 71.
- Conditions
- Advanced Malignant Solid Neoplasm, C-Reactive Protein Measurement, Cancer Fatigue, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Weight Loss
- Being tested
- Anamorelin Hydrochloride, Exercise Intervention, Laboratory Biomarker Analysis, Nutritional Assessment, Quality-of-Life Assessment
- Medical subject headings
- Neoplasm Metastasis, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anamorelin HydrochlorideDrug
Also called RC-1291 HCl
Given PO
Exercise InterventionBehavioural
Undergo physical activity
Laboratory Biomarker AnalysisOther
Correlative studies
Nutritional AssessmentOther
Also called Dietary Assessment, dietary counseling, nutritional counseling
Undergo nutritional counseling
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (anamorelin, physical activity, counseling) | Experimental | Patients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21. Receives: Drug: Anamorelin Hydrochloride; Behavioral: Exercise Intervention; Other: Laboratory Biomarker Analysis; Other: Nutritional Assessment; Other: Quality-of-Life Assessment; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. We calculated the mean change in FACIT-F fatigue subscale from baseline to Day 43.
Measured: Baseline up to day 43
Secondary outcomes (3)
The Edmonton Symptom Assessment Scale (ESAS)-Fatigue
The Edmonton Symptom Assessment Scale (ESAS) is used to rate the intensity of ten common symptoms including fatigue experienced by cancer patients. The ESAS allows patients to rate the intensity of their fatigue using a 0-10 scale (0 = not at all, 10 = worst possible). The total ESAS score range from 0-100. The lower the score, the lower the fatigue level. We calculated the mean change in ESAS fatigue score from baseline to Day 43.
Measured: Baseline up to day 43
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue
The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely fatigue"). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF general fatigue score from baseline to Day 43.
Measured: Baseline up to day 43
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue
The MFSI-SF is a 30-item multidimensional tool used to measure cancer related fatigue experienced in the past week. It consists of 5 empirically derived subscales: general, physical, emotional, mental and vigor. For each item, patients indicated their response on a 5-point Likert scale from 0 ("not at all") to 4 ("extremely fatigue"). Each of the 5 sub-scale score ranges from 0 to 24. The lower the score, the lower the fatigue level. We calculated the mean change in MFSI-SF physical fatigue score from baseline to Day 43.
Measured: Baseline up to day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start8 Feb 2017
- Primary completion27 Dec 2019
- Study completion28 Feb 2028 (estimated)
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 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
- NCT03035409
- Sponsor's protocol ID
- 2016-0655
- Other IDs
- NCI-2017-00188, 2016-0655
- Status last verified
- May 2026
- First submitted
- 26 Jan 2017
- Last updated
- 18 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Yennurajalingam S, Basen-Engquist K, Reuben JM, Fellman BM, Shete S, Maddi R, Williams JL, Dev R, Hui D, Bruera E. Anamorelin combined with physical activity, and nutritional counseling for cancer-related fatigue: a preliminary study. Support Care Cancer. 2022 Jan;30(1):497-509. doi: 10.1007/s00520-021-06463-8. Epub 2021 Jul 31.
PubMed 34331589
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anamorelin on Cancer-Related-Fatigue in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03035409
- Acronym / sponsor ID
- 2016-0655
- Conditions
- Advanced Malignant Solid Neoplasm, C-Reactive Protein Measurement, Cancer Fatigue, Metastatic Malignant Solid Neoplasm, Recurrent Malignant Solid Neoplasm, Weight Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 129 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 27 Dec 2019 (actual)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 3 Feb 2022
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 trial studies how well anamorelin hydrochloride, physical activity, and nutritional counseling work in decreasing cancer-related fatigue in patients with incurable solid tumors that have spread to other parts of the body or have come back. Anamorelin hydrochloride, physical activity, and nutritional counseling may help to decrease cancer-related fatigue in patients with solid tumors.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate changes in the Functional Assessment of Cancer Illness Therapy-Fatigue (FACIT-F) subscale score at day 43 +/- 3 days compared to baseline in patients with advanced cancer receiving oral anamorelin hydrochloride (anamorelin) 100 mg daily and standardized physical activity and nutritional counseling.
SECONDARY OBJECTIVES:
- To examine the effects of anamorelin and standardized physical activity and nutritional counseling on health-related quality of life and patient reported outcomes as measured by the Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF), Patient Reported Outcomes Measurement Information System (PROMIS) - Fatigue, Hospital Anxiety Depression Scale (HADS), Edmonton Symptom Assessment Scale (ESAS), Functional Assessment of Cancer Therapy (FACT-G) and its Functional Assessment of Anorexia/Cachexia Treatment (FAACT) subscale in these patients.
II. To examine the side effects and tolerability of anamorelin in these patients.
EXPLORATORY OBJECTIVES:
- To explore the effects of anamorelin and standardized physical activity and nutritional counseling on muscle function (as measured by the 30 second chair stand test, 6 minute walk test, day time activity [accelerometer], body composition [as measured by INBODY], and resting energy expenditure [measured by indirect calorimetry]).
II. To characterize the effects of anamorelin on potential inflammatory biomarkers of cancer-related fatigue (CRF) (C-Reactive Protein [CRP], monocyte IL-6\&R, TNF-a\&R, IL-10, IL-8, IL-1\&RA; IGF-1).
III. To explore the effects of anamorelin on sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).
IV. To determine the association between change in FACIT-F scores and changes in muscle function, day time activity, and body composition, in patients with advanced cancer receiving oral anamorelin 100 mg daily and standardized physical activity and nutritional counseling.
OUTLINE:
Patients receive anamorelin hydrochloride orally (PO) once daily (QD) and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21.
After completion of study treatment, patients are followed up on day 71.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (anamorelin, physical activity, counseling) | Experimental | Drug: Anamorelin Hydrochloride, Behavioral: Exercise Intervention, Other: Laboratory Biomarker Analysis, Other: Nutritional Assessment, Other: Quality-of-Life Assessment, Other: Questionnaire AdministrationPatients receive anamorelin hydrochloride PO QD and undergo physical activity consisting of resistance exercises and a home walking program. Treatment continues for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo nutritional counseling on day 21. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient with a diagnosis of advanced cancer (metastatic or recurrent incurable solid tumors excluding prostate cancer)
- Presence of fatigue on FACIT-F subscale of =< 34 on a 0 to 52 scale (in which 52 = no fatigue and 0 = worst possible fatigue)
- Patient should describe fatigue as being present for a minimum of 2 weeks prior to screening
- CRP must be >= 3 mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
- No evidence of moderate to severe depression as determined by a HADS depression score of =< 13
Key exclusion criteria (11 listed)
- Major contraindications to anamorelin e.g. hypersensitivity
- Regularly engaged in moderate or vigorous-intensity exercise for at least 5 times a week
- Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
- Pregnant or lactating women, childbearing age women who are not on birth control; negative pregnancy test for women of childbearing potential, as defined by intact uterus and ovaries, and a history of menses within the last 12 months; pregnancy test to be performed no greater than 14 days prior to consent in study; in cases of women with elevated b-HCG, these candidates will be eligible to participate so long as the level of b-HCG is not consistent with pregnancy; women of childbearing potential need to be on or use contraception, or be abstinent during the study period; their male partners must also use contraception (condom) or maintain abstinence; birth controls specifications: women who are able to become pregnant must use birth control during the study and for 30 days after the last anamorelin dose; acceptable forms of birth control include barrier methods (such as condom or diaphragm) with spermicide
- Uncontrolled diabetes mellitus (fasting blood sugar > 200 mg/dl) at screening
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 |
|---|---|---|
| Anamorelin HydrochlorideAlso: RC-1291 HClGiven PO | Drug | Supportive Care (anamorelin, physical activity, counseling) |
| Exercise InterventionUndergo physical activity | Behavioural | Supportive Care (anamorelin, physical activity, counseling) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive Care (anamorelin, physical activity, counseling) |
| Nutritional AssessmentAlso: Dietary Assessment, dietary counseling, nutritional counselingUndergo nutritional counseling | Other | Supportive Care (anamorelin, physical activity, counseling) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Supportive Care (anamorelin, physical activity, counseling) |
| Questionnaire AdministrationAncillary studies | Other | Supportive Care (anamorelin, physical activity, counseling) |
Primary outcome
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Baseline up to day 43
FACIT Fatigue Subscale is a short, 13-item, easy to administer tool that measures an individual's level of fatigue during their usual daily activities over the past week. The level of fatigue is measured on a four point Likert scale (4 = not at all fatigued to 0 = very much fatigued). The total score range is from 0-52. The higher the score, the lower the fatigue level. We calculated the mean change in FACIT-F fatigue subscale from baseline to Day 43.
3 secondary outcomes
The Edmonton Symptom Assessment Scale (ESAS)-Fatigue
Time frame: Baseline up to day 43
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], General Fatigue
Time frame: Baseline up to day 43
Multidimensional Fatigue Symptom Inventory-Short Form [MFSI-SF], Physical Fatigue
Time frame: Baseline up to day 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34331589Yennurajalingam S, Basen-Engquist K, Reuben JM, Fellman BM, Shete S, Maddi R, Williams JL, Dev R, Hui D, Bruera E. Anamorelin combined with physical activity, and nutritional counseling for cancer-related fatigue: a preliminary study. Support Care Cancer. 2022 Jan;30(1):497-509. doi: 10.1007/s00520-021-06463-8. Epub 2021 Jul 31.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingObservational study
Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program
Advanced Solid Tumor
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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 study testing Anamorelin Hydrochloride, Exercise Intervention and Laboratory Biomarker Analysis in people with Advanced Malignant Solid Neoplasm and C-Reactive Protein Measurement, 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 12 inclusion and 11 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 18 Jun 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 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 3 Feb 2022). 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?
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) (time frame: Baseline up to day 43). 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 NCT03035409, 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 18 Jun 2026.