Massage Therapy Compared to Light Touch Therapy in Decreasing Cancer-Related Fatigue in Breast Cancer Survivors

Active:	No
Cancer Type:	Breast Cancer Unknown Primary	NCT ID:	NCT01926678
Trial Phases:		Protocol IDs:	IRB00062853 (primary) R21AT007090
Eligibility:	18 Years and older, Female	Study Type:	Supportive care
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT01926678

Summary

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.

Objectives

PRIMARY OBJECTIVES:
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.

SECONDARY OBJECTIVES:
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.

TERTIARY OBJECTIVES:
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.

**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.