URCC 14040: A Randomized Clinical Trial Comparing the Effectiveness of Yoga, Survivorship Health Education, and Cognitive Behavioral therapy for Treating Insomnia in Cancer Survivors Save

Date Added
March 15th, 2016
PRO Number
Pro00053106
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Brain, Cancer/Breast, Cancer/Gastrointestinal, Cancer/Genitourinary, Cancer/Gynecological, Cancer/Head & Neck, Cancer/Leukemia, Cancer/Lung, Cancer/Lymphoma, Cancer/Myeloma, Cancer/Other, Cancer/Sarcoma, Cancer/Skin, Education, Exercise, Sleep Disorders
Summary

This research study is for patients who have completed all scheduled surgery, chemotherapy and/or radiation therapy for their cancer within the last 6-12 months and are currently having some type of sleep disturbance. While there is no standard treatment for sleep disturbance for cancer survivors, people who do not take part in this study may take over-the-counter or prescription medications, receive cognitive behavioral therapy, or exercise as a means of attempting to manage their sleep problems.

Sleep disturbance, particularly insomnia, is a common problem for cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than you would like. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as your biological clock) to be disrupted and decrease quality of life.

Because there is no ideal standard of care for effectively treating sleep problems in cancer survivors, the purpose of this study is to compare the effectiveness of three different treatments for improving sleep problems and determine which is best. The three treatments are yoga, survivorship health education, and cognitive behavioral therapy (CBT-I).

Study participation will be approximately 8 months.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

WFU 97115 - A Phase III Prospective Randomized Trial of Acupuncture for Treatment of Radiation-Induced Xerostomia in Patients with Head and Neck Cancer Save

Date Added
January 19th, 2016
PRO Number
Pro00050521
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Head & Neck, Cancer/Other
Summary

This research study is for patients who have xerostomia (dry mouth) caused by radiation treatment received in the past for cancer.

The purposed of this study is to determine whether or not acupuncture can improve symptoms related to dry mouth due to head/neck radiotherapy.

Eligible participants will be randomized (assigned by a computer) to one of three groups: the standard of care group (group where usual care for dry mouth is given) or to one of two acupuncture groups. One of the acupuncture treatment approaches has not been studied in a large randomized trial and may not target symptoms. Each group is equally important in the trial. All groups play an important role in helping to determine if acupuncture helps decrease symptoms of dry mouth.

Participation will last up to 9 months. About 240 people will be enrolled in this trial.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
GNorris@ghs.org

A211102, Testing for Atypia in Random Periareolar Fine Needle Aspiration (RPFNA) Cytology after 12 months Metformin (1, 1-Dimethylbiguanide Hydrochloride) Chemoprevention versus Placebo Control in Premenopausal Women Save

Date Added
April 21st, 2015
PRO Number
Pro00043305
Researcher
Jeffrey Giguere
Keywords
Cancer, Cancer/Breast, Women's Health
Summary

This study is for females, ages 25-55, who have tested positive for atypia (early cell changes that are thought to be a marker of breast cancer risk) in the breast, and are considered high risk for the development of breast cancer in the future.

The purpose of this research study is to test whether metformin, a drug commonly used to treat diabetes, is able to get rid of atypia (marker of breast cancer risk) in women at increased risk for breast cancer. This study will test for the presence of atypia in the breast after metformin is given to see if it can get rid of atypia. The study sponsor would like to compare the effects, good and/or bad, of metformin or placebo on atypia to find out which is better. In this study, patients will get either metformin or a placebo (an inactive product) for the first twelve months. After the first twelve months, women who received placebo during the first twelve months can choose to receive metformin for the second year.

Note: The standard drug used for the "breast cancer prevention" is tamoxifen. If you are eligible to take tamoxifen, you must be offered tamoxifen prevention as part of your clinical care and you must have refused tamoxifen treatment to be on this study. Metformin and tamoxifen are not similar and function differently. This study is not investigating the use of tamoxifen.

While on this research study patients will have the Random Periareolar Fine Needle Aspiration (RPFNA) of their breasts to test for atypia (marker of breast cancer risk), before the study starts, and also at 12 and 24 months (24 month optional for placebo-only group for patients who remain on placebo arm and will not receive metformin) after the study starts. If the pathologist does not identify atypia in the samples you will not be able to participate. You will also provide blood during this study to determine if changes in your blood are related to changes in your breasts. You will need to provide a little less than 4 tablespoons of blood for this research study.

Study participation will last for 48 months (2 years).

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
gnorris@ghs.org

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