Integrative Health Approaches for Breast Cancer Survivors

Recruiting at 3 trial locations

Overseen By Patricia Moran, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Metastatic disease, Recent surgery, Severe depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 6 months

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two different integrative health approaches for breast cancer survivors who have completed primary treatments such as surgery or chemotherapy. One group will try the Ayurveda Intervention (AVI), which includes nutrition, lifestyle advice, yoga, and marma (a type of therapeutic touch). The other group will receive the Facing Forward Health Education Intervention (FFHEI) with online sessions and videos. The researchers aim to determine if these methods are feasible and accepted by participants. The trial seeks participants who feel their quality of life needs improvement and who have been in complete remission from non-metastatic breast cancer for 1 to 36 months. As an unphased trial, this study offers a unique opportunity to explore innovative health approaches that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants with non-metastatic disease receiving anti-Her2 treatment are eligible, suggesting some treatments may be continued. It's best to discuss your specific medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Ayurveda, part of the Ayurveda Intervention (AVI), is generally well-tolerated. Some studies found that patients using Ayurvedic herbs during or after chemotherapy experienced fewer side effects, such as nausea and fatigue. This suggests the treatment is likely safe for most people. However, consulting a doctor before starting any new treatment is always important.

For the Facing Forward Health Education Intervention (FFHEI), similar programs have been well-received and have shown few negative effects. One study found that nearly all participants completed virtual sessions without issues. This indicates that the health education sessions are likely safe and comfortable for participants. Always consult a doctor to ensure any treatment is appropriate. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for breast cancer survivors because they incorporate integrative health approaches that aren't typically part of standard care. Unlike traditional treatments that focus solely on medical interventions, the Ayurveda Intervention (AVI) combines nutrition education, lifestyle changes, yoga, and marma therapeutic touch, offering a holistic approach to wellness. Meanwhile, the Facing Forward Health Education Intervention (FFHEI) provides structured online health education sessions, empowering participants with knowledge and support during their recovery. These approaches aim to improve quality of life and holistic health, offering new ways to support survivors beyond conventional treatments.

What evidence suggests that this trial's treatments could be effective for breast cancer survivors?

This trial will compare two integrative health approaches for breast cancer survivors. Participants in one arm will receive the Ayurveda Intervention (AVI), which includes nutrition advice, yoga, and healing touch. Research has shown that Ayurveda can improve mood, enhance cognitive function, and relieve symptoms in cancer survivors. In one case, a person lived more than 10 years without cancer after using Ayurvedic treatment.

In the other arm, participants will receive the Facing Forward Health Education Intervention (FFHEI). Studies have shown that educational programs like FFHEI can enhance understanding of cancer care, encourage exercise, and promote healthier eating. These programs have successfully reduced anxiety and improved quality of life. ^{1 2 6 7 8}

Who Is on the Research Team?

Anand Dhruva, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for non-metastatic breast cancer survivors. It's designed to see if two different health approaches are practical and well-received in a multi-site setting. Participants must be past the initial treatment phase of their cancer.

Inclusion Criteria

I have received chemotherapy as part of my initial cancer treatment.

Able to read, write, and understand English

I understand and can follow the study's procedures.

Exclusion Criteria

I had cancer surgery, including breast reconstruction, within the last month.

Severe depression assessed by the Patient Health Questionnaire Depression scale (PHQ-8) using a cutoff score of 20 or higher or severe anxiety assessed by the Generalized Anxiety Disorder Questionnaire (GAD-7) using a cutoff score of 15 or higher

I am scheduled for cancer surgery within the next 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Ayurveda Intervention (AVI) or Facing Forward Health Education Intervention (FFHEI) over 6 months. AVI includes nutrition education, lifestyle practices, yoga, and marma therapeutic touch. FFHEI involves self-directed online health education sessions.

6 months

Up to 14 in-person visits for AVI, up to 15 online sessions for FFHEI

Follow-up

Participants are monitored for safety and effectiveness after treatment. AVI participants may have monthly videoconference visits for 6 months.

6 months

6 monthly videoconference visits for AVI

What Are the Treatments Tested in This Trial?

Interventions

• Ayurveda Intervention (AVI)
• Facing Forward Health Education Intervention (FFHEI)

Trial Overview The study compares two integrative health interventions: Ayurveda Intervention (AVI) which includes nutrition, yoga, lifestyle counseling, and marma therapy; versus Facing Forward Health Education Intervention (FFHEI), which offers online educational content on survivorship.

How Is the Trial Designed?

Group I: Health Education and Usual Care (HEI) Experimental Treatment 2 Interventions

Participants receive usual care on study. Participants also attend online HEI sessions over 1 hour each for up to 15 sessions over 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.

Group II: Ayurveda and Usual Care (AVI) Experimental Treatment 5 Interventions

Participants receive usual care on study. Participants also receive nutrition education, lifestyle recommendations, and participate in yoga, as well as marma therapeutic touch during one-on-one AVI visits over 1-2 hours for up to 14 visits over 6 months. After 6 months, participants may also complete a videoconference visit over 30 minutes once monthly for 6 months. In addition, participants will complete online questionnaires at baseline and at the end of 6 months.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10847158/

Eleven years of disease free survival in a case of Invasive ... The survival of 11 years till date with Karnofsky score of 90/100 is a remarkable outcome of the treatment. We highlight that the patient's ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7716077/

A 4-Month Whole-Systems Ayurvedic Medicine Nutrition ... This 4-month Ayurvedic whole-systems multimodal nutrition and lifestyle intervention was feasible and acceptable for breast cancer survivors.

3. journals.sagepub.com journals.sagepub.com/doi/pdf/10.1089/acm.2014.5196.abstract

Qualitative Analyses from a Prospective Clinical Study of a ... the link between the intervention and study outcomes, and ex- plore mechanisms. Methods: Female breast cancer patients who had undergone chemotherapy and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0975947624000974

Adjunct Ayurvedic treatment providing more than 10 years ... Case Report. Adjunct Ayurvedic treatment providing more than 10 years of disease-free survival in a rare case of male breast cancer patient with high-grade ...

5. ascopost.com ascopost.com/issues/september-25-2025/ayurveda-in-cancer-care/

Ayurveda in Cancer Care In oncology settings, a pilot study of breast cancer survivors found improvements in emotional and cognitive functioning, symptom relief, and ...

6. researchgate.net researchgate.net/publication/262146720_Qualitative_Analyses_from_a_Prospective_Clinical_Study_of_a_Whole_Systems_Ayurvedic_Intervention_for_Breast_Cancer_Survivorship

Qualitative Analyses from a Prospective Clinical Study of a ... Qualitative Analyses from a Prospective Clinical Study of a Whole Systems Ayurvedic Intervention for Breast Cancer Survivorship.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0975947622001358

Integrating ayurvedic medicine into cancer research ... This review aims to encourage research into mechanisms and safety of Ayurvedic herbs and efficacy of protocols to be integrated into cancer care and prevention.

8. journals.lww.com journals.lww.com/ijai/fulltext/2021/02010/a_study_on_the_ayurveda_intervention__virechana__.6.aspx

A study on the Ayurveda Intervention (Virechana The study was conducted to assess the ayurvedic intervention Virechana- therapeutic purgation and Rasayana- rejuvenation on predisposed familial breast cancer ...