Integrative Approaches for Cancer Survivorship (IACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01488123
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : October 26, 2016
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Individualized manualized Ayurvedic intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Whole Systems Approach to the Study of Ayurveda for Cancer Survivorship, Project II
Study Start Date : January 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ayurvedic 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).

Primary Outcome Measures :
  1. Change in quality of life over 16 weeks [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01488123

United States, California
University of California, San Francisco, Osher Center for Integrative Medicine
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Anand Dhruva, MD University of California, San Francisco

Responsible Party: University of California, San Francisco Identifier: NCT01488123     History of Changes
Other Study ID Numbers: A112313
5K23AT005340-03 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by University of California, San Francisco:
Breast, Cancer, Survivorship, Integrative, Complementary