Calcitriol, Physical Activity, and Bone Health in Cancer Survivors
A Pilot Study of the Effects of High-Dose Oral Calcitriol and Physical Activity on Bone Health in Breast Cancer Survivors
Both the calcitriol and exercise interventions are aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass. Both calcitriol and exercise are efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on breast cancer patients and survivors. The combination of calcitriol and exercise, which function through different but similar mechanisms, could produce interactive effects in reducing fracture risk among breast cancer survivors.
Hypothesis: A combination of calcitriol along with a structured home-based walking and progressive resistance exercise program will be efficacious in preventing bone resorption and in increasing bone formation among survivors of invasive breast cancer.
調査の概要
詳細な説明
Primary Objective
To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for improving bone health among breast cancer survivors.
Secondary Objectives
To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for increasing strength among breast cancer survivors.
To collect data on the efficacy and feasibility of a supplementation of calcitriol with/without an accompanying structured home-based walking/progressive resistance exercise program for improving skeletal muscle mass among breast cancer survivors.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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New York
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Rochester、New York、アメリカ、14642
- University of Rochester Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Must be female.
- Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended.
- Must provide informed consent.
- Must be willing to discontinue use of calcium and/or vitamin D supplements.
- Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.2mg/dl.
- Must have a functional capacity rating of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.
- Must have the approval of their treating physician (or physician's nurse practitioner or physician's assistant) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program and to receive the 12-week supplementation of calcitriol 45 μg. Participants assigned to either of the calcitriol treatment arms will be instructed to stop taking calcium and/or vitamin D supplements.
- Must be less than five years from the diagnosis of breast cancer and have received chemotherapy, radiation therapy, and/or hormonal therapy. Chemotherapy and radiation therapy, if received, must have been completed prior to study enrollment. Hormonal therapy may be ongoing.
Exclusion Criteria:
- Subjects with life-threatening conditions that would preclude them from breast cancer treatment including chronic cardiac failure, which is unstable despite medication use, uncontrolled hypertension, uncontrolled diabetes mellitus, or unstable coronary artery disease.
- Patients who had a myocardial infarction within the past year.
- Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
- Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
- Patients with hypercalcemia (corrected serum Ca > 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity.
- Patients currently taking calcium supplements or aluminum-based antacids must be willing to discontinue their use if they are to enroll in the study.
- Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.
- Patients with a known sensitivity to calcitriol.
- Women who are pregnant or lactating.
- Previously verified diagnosed of osteoporosis.
- Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.
- Patients not capable of participating in an exercise intervention due to severe knee arthrosis or ligament/cartilage injuries of the lower extremities.
- Women currently using oral contraception.
- Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).
- Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：Multivitamin
Multivitamin used as control group.
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他の名前：
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実験的：Exercise
Exercise consisting of progressive walking and resistance band training.
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Exercise consisting of progressive walking and resistance band training
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実験的：Calcitriol
Calcitriol pill taken once per week.
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Calcitriol tablet taken once per week.
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実験的：Calcitriol and Exercise
Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training.
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Exercise consisting of progressive walking and resistance band training
Calcitriol tablet taken once per week.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Bone Resorption (Exercise)
時間枠：Week 12
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Bone Resorption using Serum NTx (Exercise comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (NM) Bone Collagen Equivalents (BCE). |
Week 12
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Bone Resorption (Calcitriol)
時間枠：Week 12
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Bone Resorption using Serum NTx (Calcitriol comparison) Serum NTx level is used to aid in predicting skeletal response (bone mineral density) to antiresorptive therapy and in monitoring bone resorption changes following initiation of antiresorptive therapy. Elevated levels of serum NTx indicate elevated bone resorption. Elevated bone resorption is the primary cause of agerelated bone loss and that low bone mass often results in osteopenia and is the major cause of osteoporosis. The measurement range is in nanoMoles (nm) Bone Collagen Equivalents (BCE). |
Week 12
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Bone Formation (Exercise)
時間枠：Week 12
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Bone Formation using Serum BSAP (Exercise comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies. |
Week 12
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Bone Formation (Calcitriol)
時間枠：Week 12
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Bone Formation using Serum BSAP (Calcitriol comparison) The Bone-Specific Alkaline Phosphatase (BSAP) assay provides a general index of bone formation and a specific index of total osteoblast activity. BSAP and osteocalcin are the most effective markers of bone formation and are particularly useful for monitoring bone formation therapies and antiresorptive therapies. |
Week 12
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Handgrip (kg) Strength - (Exercise)
時間枠：Week 12
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Handgrip (kg) Strength (Exercise comparison) Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength. |
Week 12
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Handgrip (kg) Strength - (Calcitriol)
時間枠：Week 12
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Handgrip (kg) Strength - (Calcitriol comparison) Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. It is typically measured in kilograms or pounds and varies by sex and age. Normative data for females is AGE 35-39 --> 20.3-34.1kg; AGE 40-44 --> 18.9-32.7kg; AGE 45-49 --> 18.6-32.4kg; AGE 50-54 --> 18.1-31.9kg; AGE 55-59 --> 17.7-31.5kg; AGE 60-64 --> 17.2-31.0kg; AGE 65-69 --> 15.4-27.2kg; AGE 70-99 --> 14.7-24.5kg. Values less than the normal range are considered weak strength. Values greater than the normal range are considered strong strength. |
Week 12
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Body Mass Index (Exercise)
時間枠：Week 12
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Body Mass Index (BMI) - (Exercise Comparison) Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese". |
Week 12
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Body Mass Index (Calcitriol)
時間枠：Week 12
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Body Mass Index(BMI) - (Calcitriol comparison) Measure Description: Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. Values below 18.5 represent "Underweight", 18.5 to 24.9 represent "Normal or Healthy Weight", 25.0 to 29.9 represent "Overweight" and 30.0 and above represent "Obese". |
Week 12
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Luke J Peppone, Ph.D.、University of Rochester
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RSRB00025478
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
乳房腫瘍の臨床試験
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