Glucosamine and Chondroitin for Aromatase Inhibitor Induced Joint Symptoms in Women With Breast Cancer

NCT00691678 | Completed Phase 2 Results DMC

• 1 other identifier: AAAC8748
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators are hoping to learn if glucosamine with chondroitin can help relieve joint pain/stiffness associated with aromatase inhibitors.

Conditions

Breast Cancer; Joint Pain

Keywords

breast cancer; aromatase inhibitor; supportive care

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 24 weeks

Study Arms (1)

chondroitin and glucosamine

EXPERIMENTAL

Postmenopausal breast cancer patients that have joint symptoms induced by aromatase inhibitors and are receiving chondroitin and glucosamine.

Drug: Chondroitin; Drug: Glucosamine

Interventions

Chondroitin DRUG

400mg chondroitin three times a day (TID) for twenty-four weeks

Also known as: Chondroitin sulfate

chondroitin and glucosamine

Glucosamine DRUG

500mg glucosamine TID for twenty-four weeks

Also known as: Glucosamine sulfate

chondroitin and glucosamine

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• Dawn L. Hershman: lead

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Arthralgia

Interventions

Chondroitin; Chondroitin Sulfates; Glucosamine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Hexosamines; Amino Sugars

Results Point of Contact

• Title: Dawn L. Hershman, MD
• Organization: Columbia University

dlh23@cumc.columbia.edu

212-305-1945

Study Officials

• Dawn Hershman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine & Epidemiology

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 8, 2022
• Results First Posted: November 8, 2022

Record last verified: 2022-10

Locations

US (1)