Clinical trial · Interventional
Integrative Approaches For Cancer Survivorship 2: Project 1
Developing an Integrative Ayurvedic Intervention for Breast Cancer Survivorship
NCT02897635CI-TRIAL-00037421IACS2completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to develop and test a 12-month Integrative Medicine intervention based on Ayurvedic medicine in recent breast cancer survivors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized Integrative Medicine Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Integrative Medicine Intervention
- description
- Study participants will attend 14 visits with an integrative medicine clinician over the course of 6 months followed by a 6 month maintenance phase. The treatment modalities employed in the study will include nutrition and lifestyle recommendations.
- interventionNames
- Behavioral: Individualized Integrative Medicine Intervention
Primary outcomes (1)
- measure
- Change in quality of life over 12 months
- timeFrame
- Baseline, 3 months, 6 months, 12 months
- description
- The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) in conjunction with a Breast Cancer-Specific Subscale (BR23) to collect data on qualify of life and cancer-related symptoms.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female breast cancer survivor who is over 1 month and less than 24 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 complete remission * Aged 18 years or older * Able to read, write, and understand English * Karnofsky Performance Status (KPS) greater than or equal to 60 * Have impaired quality of life * Ability to give informed consent Exclusion Criteria: * Having received Ayurvedic treatment within 6 months of study enrollment * Receiving chemotherapy or radiotherapy at the time of study enrollment. Anti-her2 directed 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 2 months * Have surgery for breast cancer or breast reconstructive surgery planned during the initial 6 month study period. Smaller surgical procedures such as implant exchange are not exclusionary.
References
Publications (0)
Data not yet available
No reference posted for this study.