High Dose Vitamin D vs Standard Dose Vitamin D Study

Samo registrirani uporabniki lahko prevajajo članke

Prijava / prijava

Povezava se shrani v odložišče

StanjePrenehala

Sponzorji

Mothaffar Rimawi

KLINIČNO PRESKUŠANJE: NCT01988090

BioSeek: nct01988090

Ključne besede

Povzetek

This study is being done to look at the difference, if there is a difference between two different doses of Vitamin D and the reduction of joint/muscle pain (arthralgia)that is caused by taking anti-estrogen medications (aromatase inhibitors) by breast cancer patients. The investigators hope to learn if taking a higher dose of Vitamin D is a good way to prevent aromatase inhibitor arthralgia (AIA).

Opis

Treatments with anti-estrogen agents for hormone receptor positive breast cancer is the most efficacious of systemic therapies, with aromatase inhibitors (AI's) being considered the most active anti-estrogen therapy in early stage breast cancer. But, use of these treatments has been shown to cause musculoskeletal (joint/muscle) side effects that sometimes cause patients to discontinue the use of them. Also, Vitamin D deficiency is a well know cause of a wide array of musculoskeletal issues. There is evidence that Vitamin D supplementation may help prevent arthralgia while on AI's. Therefore, the investigators want to see if giving a higher dose of Vitamin D could decrease the incidence of AIA as compared to a standard dose of Vitamin D. The investigators believe that this could possibly result in patients continued treatment with AI therapy for hormone receptor positive breast cancer.

Datumi

Nazadnje preverjeno:	06/30/2020
Prvič predloženo:	11/06/2013
Predviden vpis oddan:	11/12/2013
Prvič objavljeno:	11/19/2013
Zadnja posodobitev oddana:	07/08/2020
Zadnja posodobitev objavljena:	07/23/2020
Datum prvič predloženih rezultatov:	01/30/2019
Datum prve oddaje rezultatov QC:	02/27/2019
Datum prvič objavljenih rezultatov:	03/18/2019
Dejanski datum začetka študija:	11/30/2013
Predvideni datum primarnega zaključka:	07/20/2018
Predvideni datum zaključka študije:	12/09/2018

Stanje ali bolezen

Breast Cancer

Intervencija / zdravljenje

Drug: 800 IU Vitamin D Supplement

Drug: High Dose Vitamin D ARM

Faza

Faza 2

Skupine rok

Roka	Intervencija / zdravljenje
Experimental: High Dose Vitamin D ARM 50,000 IU Vitamin D supplement	Drug: High Dose Vitamin D ARM High Dose
Active Comparator: 800 IU Vitamin D Supplement 800 IU Vitamin D Supplement	Drug: 800 IU Vitamin D Supplement Standard Dose

Merila upravičenosti

Starost, primerna za študij	18 Years Za 18 Years
Spol, upravičen do študija	Female
Sprejema zdrave prostovoljce	Da
Merila	Inclusion Criteria: - All participants must be female and at least 21 years of age - Signed informed consent - Patients must have had histologically confirmed stage I-III breast carcinoma that is positive for Estrogen Receptor (ER) and/or Progesterone Receptor (PR). - Post-menopausal - Beginning adjuvant aromatase inhibitor therapy, with no previous use within the last 6 weeks - Bisphosphonates are allowed at the treating investigator¡¦s discretion - Performance status (WHO/ECOG scale) 0-2. Exclusion Criteria: - History of kidney stones - Hypercalcemia at baseline, defined as any corrected calcium greater than the laboratory's normal parameters - History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator's discretion - Baseline Vitamin D level greater than 50 ng/mL - Inability or unwillingness to comply with, or follow study procedures. - Currently taking Phenytoin or phenobarbital -7 Currently taking cholestyramine or orlistat - Malabsorption syndrome, such as Crohn's disease Prohibited Therapies: Patients may not take additional Calcium and Vitamin D aside from the study medications. Patients who are on cholestyramine or orlistat will not be allowed on the trial. Also, patients who are taking phenytoin or phenobarbital are not allowed on the trial either because of interaction between Vitamin D and anti-epileptic medications.

Izid

Primarni izidni ukrepi

1. Number of Participants With Aromatase Inhibitor Induced Arthralgia (AIA) After 12 Weeks of Therapy [12 weeks]

Aromatase Inhibitor Arthralgia (AIA) was assessed by a questionnaire that describe the level of pain experienced by the participant. The questionnaire asks 20 questions scored 0-3 in 8 categories of functioning: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. An average composite score on the HAQ-II was calculated. The visual analog scale is the other major component of the HAQ-II, which we ask patients to mark where their pain lies on a horizontal line and we converts the number into a score from 0 to 3. For the purposes of this study, AIA will be defined as any of the following criteria: 1) increase in HAQ-II score from baseline by 0.2 or greater; or 2) increase in visual analog pain score by 0.3 or greater.

Ukrepi sekundarnega rezultata

1. Compliance With Anti-Cancer Treatment [52 Weeks]

We checked compliance of aromatase inhibitor therapy during the study by reviewing the patient's use of AI drug. This will be done by counting remaining pills in patient's bottles of AI at 52 weeks. A percentage of the number of pills were actually taken of the number of pills should be taken was calculated.

2. Association Between Vitamin D Levels Changes and Treatment. [12 weeks]

Patients' serum 25-hydroxyvitamin D level were tested at baseline and week 12. The changes between baseline and week 12 were calculated.

Drugi izidni ukrepi

1. Grip Strength [52 weeks]

Exploratory Endpoints For each patient on the study, grip strength will be correlated with AIA score using Spearman correlation at three time points throughout the study - baseline, week 12, and week 52.

High Dose Vitamin D vs Standard Dose Vitamin D Study

Ključne besede

rak dojke

rak

mialgija

arthralgia

vitamin d deficiency