Integrative Approaches for Cancer Survivorship

Breast Cancer Clinical Trial

— IACS  

Official title:

A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488123
• Other study ID #: A112313
• Secondary ID: 5K23AT005340-03
• Status: Completed
• Phase: N/A
• First received: December 5, 2011
• Last updated: October 24, 2016
• Start date: January 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2016
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Behavioral:
• Individualized 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).

Locations

Country	Name	City	State
United States	University of California, San Francisco, Osher Center for Integrative Medicine	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quality of life over 16 weeks	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.	Baseline, End of week 8, End of week 16	No