A Phase 2 interventional study of Hyaluronic Acid (HA) and Placebo in Breast Neoplasm Female and Arthralgia, sponsored by Erin Newton. Withdrawn at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-02.
Sponsored by Erin Newton · Phase 2, Interventional, and Supportive care
Among 106 studies in Arthralgia with a site in United States — 17 open to participants now, 24 under way, 4 of them phase 3. Arthralgia · United States.
Among the 106 studies in Arthralgia with a site in United States, this one is the 85th largest by enrollment of the 88 interventional ones that give a count, is one of 8 that started in 2018, is one of 14 in phase 2, and was the 51st registered.
277 studies on the registry are indexed under Arthralgia; 54 are open to participants now.
Browse Arthralgia studies →17 of the 106 studies in Arthralgia with a site in United States are open now. Recruiting first, the newest first:
Indiana University · Sites in United States
Ages 18+
PainTEQ, LLC · Sites in United States
Ages 21+
PainTEQ, LLC · Sites in United States
Ages 21+
Weill Medical College of Cornell University · Sites in United States
Ages 18–75
Veterans Medical Research Foundation · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 35 Arthralgia studies recruiting now, 18 (51%) set no upper age limit and 16 (46%) stop at 75 or younger; 1 takes children under 18; 9 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
106 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 16 · Phase 3 20 · Phase 4 6
First in 2004; this study’s year is marked. 8 started in 2018.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 82 across the 88 interventional studies, 144 across the 18 observational. Of the 66 that completed or were terminated, 24 (36%) have results posted.
This tab as a report to print or save as PDF → With an account.
36 of 106 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Erin Newton as lead sponsor.
Erin Newton has 1 study filed under Arthralgia — fewer than ten, so there is no comparison to draw.
7 of the studies in Arthralgia with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05703178Phase 3Northwestern UniversityWeb-based Pain Coping Skills Training for Breast Cancer Survivors With AI-Associated Arthralgia | 2026-11-30 |
| NCT05658575Phase 3Olatec Therapeutics, Inc.Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare | 2026-12-31 |
| NCT05621369Sage BionetworksPsorcast Mobile Study | 2027-01-31 |
| NCT04994249Stanford UniversityDiagnostic and Prognostic Biomarkers for High-impact Chronic Pain: Development and Validation | 2027-04-25 |
| NCT07547215PainTEQ, LLCPost-Market Clinical Study Using TRAQ™ for Minimally Invasive Posterior Sacroiliac Joint Fusion | 2027-07 |
Add all 7 to your calendar (.ics) → With an account.
Among the 106 studies in Arthralgia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a single center, double-blinded, placebo-controlled, randomized Phase II trial to determine whether oral hyaluronic acid will prevent aromatase inhibitor (AI)-associated arthralgias. Subjects must have ER/PR-positive breast cancer tumor with history of aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) which resolved after cessation of their AI (anastrazole or letrozole) within 90 days of enrollment. Subjects will be stratified by initial AI, thus within each initial AI, subjects will be randomized to receive either the experimental treatment (hyaluronic acid) or placebo. Subjects will begin the assigned treatment for 2 weeks prior to transitioning to the second AI. Evaluations will be taken at baseline, 6 weeks (1 month on study drug and AI), 14 weeks (3 months on study drug and AI), and at 26 weeks (6 months on study drug and AI). Treatment with hyaluronic acid and placebo will last for 26 weeks total.
Primary Objective To determine whether oral HA will prevent AI-induced arthralgias and preserve physical function.
Secondary Objectives
Exploratory Objective To determine if mi486, (a microRNA enriched in skeletal muscle) and other biomarkers associated with AIMSS (TNF, IL-6, IL-17) vary with the administration of HA.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Study Population ER/PR-Positive Breast Cancer Subjects whose AIMSS resolved with cessation of their AI and are candidates for switching to a different AI and who meet the inclusion and exclusion criteria will be eligible for participation in this study.
Inclusion Criteria
Adequate renal and hepatic function:
i) Include only subjects with and ALT \< 2.0 × ; AP \< 1.5 × ULN; total \< 1.2 × ULN ii) Include only subjects with as calculated (CrCl) > 60 mL/min determined by the central laboratory using the modified Cockcroft-Gault equation; blood urea nitrogen (BUN) \< 1.5 × upper limit of normal (ULN)
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in this arm will be given 100 mg of hyaluronic acid in capsule form. Subject in this arm will be asked to 1 capsule take twice daily for 26 weeks.
Drug: Hyaluronic Acid (HA)
Subjects in this arm will be given a placebo comparator capsule that is identical to the hyaluronic capsule containing microcrystalline cellulose as the sole ingredient. Subjects in this arm will be asked to take 1 capsule twice daily for 26 weeks.
Other: Placebo
Dosage form: hyaluronic capsules; Dose: 100 mg; Frequency: twice daily; Duration: 26 weeks
Dosage form: microcrystalline cellulose (MCC) capsules; Dose: approx. 100 mg (determined by weight of HA counterpart); Frequency: twice daily; Duration: 26 weeks
Difference in mean change in joint pain between HA and placebo groups
As measured by the Brief Pain Inventory - Short Form (BPI-SF) questions #3-#6, #9A-G. This 14-item questionnaire was developed for use in patients with cancer that uses a scale from 0 to 10 to assess worst pain, pain severity, and pain interference over the past week. The first 8 items have to do with the severity of the pain, and the remaining 7 items ask about how the pain has affected function.
Time frame: 14 weeks
Incidence of treatment-emergent adverse events (i.e. safety and tolerability of HA)
Summary of adverse events as measured by CTCAE v4.0
Time frame: 30 weeks
Difference in mean joint symptoms between HA and placebo groups
As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Time frame: 6, 14, and 26 weeks
Difference in mean joint function between HA and placebo groups
As measured by Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH) scores. This 11-item instrument assesses physical function and symptoms in patients with musculoskeletal disorders of the upper limbs. It is a questionnaire scored from 1 to 5, with the higher score indicating worse symptoms, and there is a validated method to calculate a single Disability/Symptom Score.
Time frame: 6, 14, and 26 weeks
Difference in mean quality of sleep between HA and placebo groups
As measured by Pittsburgh Sleep Quality Index (PSQI) scores. This an 18-item instrument produces a global sleep-quality score and the following component scores: sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction.
Time frame: 6, 14, and 26 weeks
Difference in global change between HA and placebo groups
As measured by Patient's Global Impression of Change scale (PGIC) scores
Time frame: 6, 14, and 26 weeks
Difference in mean change in WOMAC subscale 1 scores between HA and placebo groups
As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) subscale 1 scores. As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Time frame: 6, 14, and 26 weeks
Difference in mean change in WOMAC subscale 2 scores between HA and placebo groups
As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) subscale 2 scores. As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Time frame: 6, 14, and 26 weeks
Difference in mean change in WOMAC subscale 3 scores between HA and placebo groups
As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) subscale 3 scores. As measured by Western Ontario and McMaster osteoarthritis index (WOMAC) scores. This questionnaire assesses the three domains of pain, stiffness, and physical function in the lower extremities over the past 7 days. It is scored from 0 to 100, with higher scores indicating worse symptoms.
Time frame: 6, 14, and 26 weeks
Time to discontinuation of second aromatase inhibitor due to AIMSS between HA and placebo groups
As measured by patient self-report of mediation compliance (medication diary) and chart review
Time frame: 26 weeks
Proportion of patients that remain on second aromatase inhibitor between HA and placebo groups
As measured by patient self-report of mediation compliance (medication diary) and chart review
Time frame: 26 weeks
Rate of 90% compliance between HA and placebo groups
As measured by patient self-report of mediation compliance (medication diary)
Time frame: 26 weeks
Mean frequency of as needed analgesia between HA and placebo groups
As measured by patient self-report of mediation compliance (medication diary)
Time frame: 6, 14, and 26 weeks
Plan to share: No
Ran from Dec 2018 to primary completion in Dec 2018, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hyaluronic Acid