Breast Cancer
Conditions
Keywords
Breast, Cancer, Survivorship, Integrative, Complementary
Brief summary
The purpose of this study is to determine whether a four-month manualized Ayurvedic intervention will improve quality of life in recent breast cancer survivors.
Detailed description
Cancer associated symptoms and impaired quality of life remain significant problems for patients despite advances in cancer treatment. Few effective treatment options exist for these symptoms. Integrative medicine is rising in popularity in the United States; however, few integrative medicine modalities have been rigorously studied. Ayurveda, a whole system of medicine that originated in the Indian subcontinent, has its own system of diagnostics and therapeutics, and among its strengths are wellness and prevention. We aim to perform a prospective single arm clinical study of a manualized Ayurvedic approach in breast cancer survivors with impaired quality of life. Specifically, we aim to develop the manualized Ayurvedic intervention; to assess feasibility; and to determine whether clinically meaningful effects can be achieved with the intervention.
Interventions
BEHAVIORALIndividualized manualized Ayurvedic intervention
The manualized intervention will begin with an initial clinic visit (approximately 90 minutes) with the Ayurvedic practitioner in which the patient's diagnosis will be determined, an overview of Ayurveda will be given, and the initial treatment will be recommended based on the Ayurvedic diagnosis. Follow-up visits will range between 30 and 60 minutes in duration. The treatment modalities employed in the study will include nutrition, lifestyle, yoga, and marma (a treatment similar to acupressure).
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female breast cancer survivor who is over 1 month and less than 12 months beyond the completion of primary therapy (surgery, radiation, and chemotherapy) * Having received chemotherapy as part of their primary therapy for breast cancer * Be in a complete remission * Aged 18 years or older * Able to read, write, and understand English * Karnofsky Performance Status (KPS) 67 greater than 60. * Ability to give informed consent
Exclusion criteria
* Having received Ayurvedic treatment within 2 months of study enrollment * Receiving chemotherapy or radiotherapy at the time of study enrollment. Trastuzumab therapy is not exclusionary. * Being within 1 month (before or after) of surgery for breast cancer (including breast reconstructive surgery). Smaller surgical procedures such as implant exchange are not exclusionary. * Patients on adjuvant hormone therapy for less than 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in quality of life over 16 weeks | Baseline, End of week 8, End of week 16 | The investigators will use the EORTC QLQ C30 (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) 68 in conjunction with a breast cancer-specific subscale, BR23, to collect data on quality of life and cancer-related symptoms. |
Countries
United States
Outcome results
None listed