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Integrative Approaches for Cancer Survivorship

NCT ID: NCT01488123

Last Updated: 2016-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-10-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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Breast, Cancer, Survivorship, Integrative, Complementary

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Ayurvedic Intervention

Group Type EXPERIMENTAL

Individualized manualized Ayurvedic intervention

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anand Dhruva, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco, Osher Center for Integrative Medicine

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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5K23AT005340-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A112313

Identifier Type: -

Identifier Source: org_study_id