Breast CancerPhase 2NCT00691678
Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer
A Phase 2 study testing Chondroitin and Glucosamine in people with Breast Cancer and Joint Pain, run by Dawn L. Hershman at 1 site in United States.
Trial summary
Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer, Joint Pain
- What is being tested?
- Chondroitin and Glucosamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Sep 2012
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >21 years.
- Postmenopausal status defined as cessation of menses for >1 year or follicle-stimulating hormone (FSH) >20 milli-international units per milliliter or bilateral oophorectomy.
- History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease.
- Currently taking a third-generation aromatase inhibitor for at least 3 months.
- Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry.
- Ongoing musculoskeletal pain/stiffness in hand and/or knee joints (50 or higher on the 100 point global assessment VAS) that started or increased since initiating aromatase inhibitor therapy, and has been present for at least 3 months.
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- Patients must agree to refrain from use of glucosamine and chondroitin from sources outside of this study.
- If taking bisphosphonates, on a stable dose for at least 3 months and tolerating the dose. Patients must agree to refrain from initiating bisphosphonate use during the course of the study, therefore it is recommended that routine bone density testing be performed prior to enrollment or after completing trial.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Hemoglobin A1c <8 within the last year.
- Signed informed consent.
Who cannot join
- Use of glucosamine or chondroitin within the past three (3) months.
- Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy.
- History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).
- History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.
- Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.
- History of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient.
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- Allergy to, or history of significant clinical or laboratory adverse experience associated with acetaminophen, glucosamine or chondroitin sulfate.
- Allergy to shellfish.
- Inability to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.
- Inability to understand the study procedures and/or give written informed consent.
- Alcohol use in excess of 3 mixed drinks/day.
- Corticosteroid treatment was used or administered.
- Aspirin (up to 325 mg/day) for cardiovascular reasons may be continued.
- Intra-articular injection of hyaluronic acid or congeners into the study joint within 12 months.
- Topical analgesics (e.g., capsaicin preparations) to the study joint, or any oral analgesics (e.g., opiates, tramadol; with the exception of ibuprofen and acetaminophen) within 2 weeks of baseline visit or during the study.
- Implementation of any other medical therapy for arthritis within one month prior to entry.
- Other medications, unrelated to the patient's joint pain/stiffness must have been used at a stable dosage for at least 1 month. In addition, it should be anticipated that the dose of the concomitant medication will be stable during the entire treatment period.
- Participation in another clinical study with an investigational agent within the last 4 weeks.
- Exposure to glucosamine within 3 months or chondroitin sulfate within 3 months of Baseline Visit.
- Initiation of physical therapy or muscle conditioning program within 2 months prior to study entry.
- Concurrent use of the following medications and dietary supplements.
- Chronic therapy with tetracycline or tetracycline derivatives.
- Other new complementary or alternative regimens for the treatment of osteoarthritis, including, but not limited to, acupuncture, topical creams, oral agents, and magnets.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pase II Study of Glucosamine With Chondroitin on Joint Symptoms Induced By Aromatase Inhibitors in Breast Cancer Patients
Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors.
Read the detailed description
Due to early detection and improved treatments, women with breast cancer are living longer. The increase in breast cancer survival is largely due to the benefits of hormonal therapy, such as tamoxifen and aromatase inhibitors (AIs), for the treatment of hormone-sensitive breast cancer. Recent clinical trials have demonstrated that AIs are more effective than tamoxifen at reducing breast cancer recurrences. However, breast cancer patients receiving AIs have a higher incidence of osteoporosis, bone fractures and musculoskeletal symptoms, particularly joint pain and stiffness. Musculoskeletal pain, which occurs in up to 50% of patients treated with AIs, often does not respond to conventional pain medications, may lead to noncompliance, may cause major disability, and may interfere with quality of life. Many women are unable to tolerate these life-saving drugs because of severe joint pain, therefore, safe and effective treatments that alleviate these symptoms are needed.
- Conditions
- Breast Cancer, Joint Pain
- Being tested
- Chondroitin, Glucosamine
- Keywords
- breast cancer, aromatase inhibitor, supportive care
- Medical subject headings
- Breast Neoplasms, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChondroitinDrug
Also called Chondroitin sulfate
400mg chondroitin three times a day (TID) for twenty-four weeks
GlucosamineDrug
Also called Glucosamine sulfate
500mg glucosamine TID for twenty-four weeks
| Study group | Role | What they receive |
|---|---|---|
| chondroitin and glucosamine | Experimental | Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine. Receives: Drug: Chondroitin; Drug: Glucosamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in WOMAC Score
This is to demonstrate improvement in knee and/or joint pain and/or stiffness. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2012
- Study completionSep 2012
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 Breast CancerStudies of the same condition, open and under way.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dawn L. Hershman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dawn L. Hershman, Columbia University
- Investigators
- Dawn Hershman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691678
- Sponsor's protocol ID
- AAAC8748
- Status last verified
- Oct 2022
- First submitted
- 3 Jun 2008
- Last updated
- 8 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pase II Study of Glucosamine With Chondroitin on Joint Symptoms Induced By Aromatase Inhibitors in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00691678
- Acronym / sponsor ID
- AAAC8748
- Conditions
- Breast Cancer, Joint Pain
- Keywords
- breast cancer, aromatase inhibitor, supportive care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Dawn L. HershmanUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Posted 8 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors.
Detailed description
Due to early detection and improved treatments, women with breast cancer are living longer. The increase in breast cancer survival is largely due to the benefits of hormonal therapy, such as tamoxifen and aromatase inhibitors (AIs), for the treatment of hormone-sensitive breast cancer. Recent clinical trials have demonstrated that AIs are more effective than tamoxifen at reducing breast cancer recurrences. However, breast cancer patients receiving AIs have a higher incidence of osteoporosis, bone fractures and musculoskeletal symptoms, particularly joint pain and stiffness. Musculoskeletal pain, which occurs in up to 50% of patients treated with AIs, often does not respond to conventional pain medications, may lead to noncompliance, may cause major disability, and may interfere with quality of life. Many women are unable to tolerate these life-saving drugs because of severe joint pain, therefore, safe and effective treatments that alleviate these symptoms are needed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chondroitin and glucosamine | Experimental | Drug: Chondroitin, Drug: GlucosaminePostmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age >21 years.
- Postmenopausal status defined as cessation of menses for >1 year or follicle-stimulating hormone (FSH) >20 milli-international units per milliliter or bilateral oophorectomy.
- History of stage I, II or III hormone receptor-positive breast cancer, without metastatic disease.
- Currently taking a third-generation aromatase inhibitor for at least 3 months.
- Clinical symptoms of knee and/or hand joint pain and/or stiffness for at least 3 months prior to study entry.
Key exclusion criteria (23 listed)
- Use of glucosamine or chondroitin within the past three (3) months.
- Concurrent medical/arthritic disease that could confound or interfere with evaluation of pain or efficacy.
- History of significant collateral ligament, anterior cruciate ligament or meniscal injury of the index joint requiring surgery or non-weight bearing (requiring use of crutches or cane) for more than 3 weeks (minor ligamentous injury prior to 6 months is not an exclusion).
- History of bone fracture or surgery of the afflicted knees and/or hands within 6 months prior to study entry.
- Uncontrolled diabetes mellitus, defined as Hemoglobin A1c level of > 8%.
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 |
|---|---|---|
| ChondroitinAlso: Chondroitin sulfate400mg chondroitin three times a day (TID) for twenty-four weeks | Drug | chondroitin and glucosamine |
| GlucosamineAlso: Glucosamine sulfate500mg glucosamine TID for twenty-four weeks | Drug | chondroitin and glucosamine |
Primary outcome
Change in WOMAC Score
Time frame: Baseline and 24 weeks
This is to demonstrate improvement in knee and/or joint pain and/or stiffness. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The sum of the scores for all three subscales gives a total WOMAC score which ranges from 0-96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Dawn Hershman, MD principal investigator
Columbia University
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 Chondroitin and Glucosamine in people with Breast Cancer and Joint Pain, run by Dawn L. Hershman 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 11 inclusion and 23 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: finished, as of the sponsor's last update on 8 Nov 2022. 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 8 Nov 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?
Change in WOMAC Score (time frame: Baseline and 24 weeks). 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 8 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.