AzTrials
AzTrials

Breast Neoplasm FemalePhase 2NCT03384095

Trial of Oral Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias

A Phase 2 study testing Hyaluronic Acid (HA) in people with Breast Neoplasm Female and Arthralgia, run by Erin Newton at 4 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasm Female, Arthralgia
What is being tested?
Hyaluronic Acid (HA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
4 sitesUnited States
Study dates
14 Dec 2018to 14 Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years old.
  • Had been taking anastrazole or letrozole, and discontinued it within the past 90 days due to pain and/or stiffness. The AI-related pain/stiffness must have resolved.
  • Prior tamoxifen use is allowed.
  • A prior switch from exemestane is allowed.
  • Women who have undergone a total mastectomy or breast conserving surgery for Stage 0-3 breast cancer +/- chemotherapy, +/- antiHer2Neu therapy, +/- radiotherapy.
  • Must have ER and/or PR positive tumors.
Show all 12Show fewer
  • Women who are postmenopausal by the presence of natural amenorrhea ≥ 12 months or by ovarian ablation (bilateral oophorectomy, radiation, or administration of a gonadotropin-releasing hormone agonist).
  • Eastern Cooperative Oncology Group Performance Score (ECOG PS) 0-3 (Appendix II).
  • Patients may or may not be taking non-opioid analgesics.
  • Adequate renal and hepatic function:
  • Include only subjects with AST and ALT < 2.0 × ULN; AP < 1.5 × ULN; total bilirubin < 1.2 × ULN ii) Include only subjects with as calculated creatinine clearance (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)
  • Written informed consent from subject and ability for subject to comply with the requirements of the study.

Who cannot join

  • Presence of residual or recurrent cancer.
  • Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
  • Consumption of HA-containing supplements in the four weeks prior to study.
  • Known allergy to microcrystalline cellulose or HA. Any questionable reaction to injected HA will be thoroughly investigated.
  • Prolonged systemic corticosteroid treatment, except for topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops or local insertion (i.e., intra-articular). A short duration of systemic corticosteroids is allowed but not within 30 days prior to registration.
  • Self-reported compliance issues and lack of regular prescription filling.
  • Previous diagnosis of fibromyalgia and/or rheumatoid arthritis.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Indiana University Health North Hospital

    Carmel, Indiana, 46032

  • Indiana University Health Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Health Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Spring Mill Medical Center

    Indianapolis, Indiana, 46290

Other trials in United States

About this study

Official title: Single Center, Placebo-Controlled Trial of Oral High-Molecular Weight Hyaluronic Acid for the Prevention of Aromatase Inhibitor-Associated Arthralgias

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.

Read the detailed description

Primary Objective To determine whether oral HA will prevent AI-induced arthralgias and preserve physical function.

Secondary Objectives

  1. To explore whether oral HA will have an acceptable safety and tolerability profile.
  2. To determine whether oral HA will prevent other AI associated symptoms as assessed by patient reported outcomes (PRO's).
  3. To assess how many of the subjects are 90% compliant with taking the HA as directed.

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.

Being tested
Hyaluronic Acid (HA), Placebo
Keywords
Aromatase Inhibitors
Medical subject headings
Arthralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyaluronic Acid (HA)Drug

    Dosage form: hyaluronic capsules; Dose: 100 mg; Frequency: twice daily; Duration: 26 weeks

  • PlaceboOther

    Dosage form: microcrystalline cellulose (MCC) capsules; Dose: approx. 100 mg (determined by weight of HA counterpart); Frequency: twice daily; Duration: 26 weeks

Study groups in NCT03384095
Study groupRoleWhat they receive
Hyaluronic AcidExperimentalSubjects 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.
Receives: Drug: Hyaluronic Acid (HA)
PlaceboPlacebo comparatorSubjects 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.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 14 weeks

Secondary outcomes (12)

  1. Incidence of treatment-emergent adverse events (i.e. safety and tolerability of HA)

    Summary of adverse events as measured by CTCAE v4.0

    Measured: 30 weeks

  2. 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.

    Measured: 6, 14, and 26 weeks

  3. 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.

    Measured: 6, 14, and 26 weeks

  4. 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.

    Measured: 6, 14, and 26 weeks

  5. Difference in global change between HA and placebo groups

    As measured by Patient's Global Impression of Change scale (PGIC) scores

    Measured: 6, 14, and 26 weeks

  6. 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.

    Measured: 6, 14, and 26 weeks

  7. 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.

    Measured: 6, 14, and 26 weeks

  8. 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.

    Measured: 6, 14, and 26 weeks

  9. 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

    Measured: 26 weeks

  10. 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

    Measured: 26 weeks

  11. Rate of 90% compliance between HA and placebo groups

    As measured by patient self-report of mediation compliance (medication diary)

    Measured: 26 weeks

  12. Mean frequency of as needed analgesia between HA and placebo groups

    As measured by patient self-report of mediation compliance (medication diary)

    Measured: 6, 14, and 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2017
  2. Study start14 Dec 2018
  3. Primary completion14 Dec 2018
  4. Study completion14 Dec 2018

Why it stopped: study abandoned prior to opening to accrual or study start

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03384095
Sponsor's protocol ID
IUSCC-0533
Status last verified
Dec 2018
First submitted
18 Dec 2017
Last updated
2 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.

    PubMed 35005781

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hyaluronic Acid (HA) in people with Breast Neoplasm Female and Arthralgia, run by Erin Newton at 4 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 12 inclusion and 7 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: withdrawn, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. Some participants in this study may receive a placebo. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Difference in mean change in joint pain between HA and placebo groups (time frame: 14 weeks). 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 NCT03384095, 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 2 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in