Massage Therapy Compared to Light Touch Therapy in Decreasing Cancer-Related Fatigue in Breast Cancer Survivors
18 Years and older, Female
This randomized clinical trial studies massage therapy compared to light touch therapy in decreasing cancer-related fatigue in breast cancer survivors. Cancer treatments such as chemotherapy, radiation therapy, and biologic therapy can cause fatigue in cancer patients. Fatigue can affect all areas of life by making the patient too tired to take part in daily activities, relationships, social events, and community activities. Massage therapy may help relieve cancer-related fatigue and improve energy levels and quality of life in breast cancer survivors. It is not yet known whether massage therapy is a better treatment for cancer-related fatigue than light touch therapy for breast cancer survivors.
I. To conduct a feasibility study to determine whether a 6-week Swedish massage therapy (SMT) intervention can decrease cancer-related fatigue (CRF), as measured by the Multidimensional Fatigue Inventory (MFI), among breast cancer survivors who have received radiation and/or chemotherapy/chemoprevention and have CRF.
I. To determine whether the hypothesized decrease in CRF is due to SMT modulating the immune system of subjects with CRF to decrease chronic inflammation.
I. To explore the relationship between measures of fatigue and quality of life (QOL) as assessed by the MFI and the Patient–Reported Outcomes Measurement System (PROMIS).
II. To explore the relationship between the decrease in CRF caused by SMT or light touch (LT) and pre-treatment credibility, expectancy, and preference scores.
III. To analyze the within-subject effects of SMT or LT versus wait list control (WLC) on immune function and fatigue scores for subjects initially randomized to the WLC, and to compare and contrast their change during SMT or LT to that of the groups receiving SMT or LT during the first 6 weeks of the study.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo Swedish massage therapy over 45 minutes once a week for 6 weeks.
ARM II: Patients undergo light touch therapy over 45 minutes once a week for 6 weeks.
ARM III: Patients are placed on a wait list for 6 weeks. Patients with high or moderate CRF at the end of 6 weeks are randomized to receive either massage therapy as in Arm I or light touch therapy as in Arm II.
- Ages 18-65 (women above the age of 65 may be included at principal investigator [PI] discretion)
- Patients with stage 0-III breast cancer, status-post surgery treated with standard chemotherapy/chemoprevention and/or radiation
- Patients will be between 6 months and 4-years post radiation treatment; ongoing chemoprevention therapy is permissible; based on International Classification of Diseases (ICD)-10 proposed criteria, a diagnosis of CRF will require evidence from the history, physical exam, and laboratory findings that the fatigue is a consequence of cancer or cancer therapy and not primarily a consequence of comorbid psychiatric disorders (schizophrenia, depression, generalized anxiety disorder, bipolar disorder, dementia, delirium or obsessive–compulsive disorder [OCD])
- Brief Fatigue Inventory (BFI) score of > 25
- Satisfactory results of screening safety labs, urine pregnancy test and drug test
- Ability to understand study procedures and to comply with them for the entire length of the study
- Women of reproductive capability will be enrolled, but each woman needs to discuss with the study team the method of birth control used and if the method is a reliable and effective method for her; if a woman becomes pregnant during the course of active study participation, she must agree prior to enrolling in the study that she will report the pregnancy to the study team; with a confirmed pregnancy, the subject will no longer receive the assigned treatment, but will continue to be followed per protocol
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials