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Ovarian CancerNCT00287482

Essiac (ESIAK) Versus Placebo to Improve Quality of Life in Transition in Women With Breast or Ovarian Cancer.

A study testing Essiac in people with Ovarian Cancer and Breast Cancer, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a pilot feasibility study being performed in women completing front-line treatment for breast or ovarian cancer. It is being done to evaluate whether or not an herbal combination known as Essiac (ESIAK) can improve the overall quality of life in these women as they transition from active treatment to… Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Ovarian Cancer, Breast Cancer
What is being tested?
Essiac
How many people
20 participants
Where
1 siteUnited States
Study dates
Oct 2005to Jul 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • histologically documented diagnosis of infiltrating carcinoma of the breast or epithelial ovarian cancer. Given the similar clinical course of patients with fallopian tube and primary peritoneal carcinoma these patients will also be included in the study.
  • Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
  • Patients must be either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
  • Women of child-bearing potential must have a negative pregnancy test. If patients become pregnant during the course of the study, they will not be allowed to continue on the study.
  • age ≥ 18 year-old
  • Karnofsky performance status > 70%
Show all 15Show fewer
  • Ability to understand and willingness to sign informed consent
  • Ability to perform and comply with follow-up on study
  • No history of drug or alcohol abuse
  • No antecedent history of depression prior to diagnosis of malignancy
  • Must be ≥ 4 weeks from completion of chemotherapy or radiation therapy.
  • Adequate hematopoietic function defined as: ANC ≥ 1500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 8 g/dL.
  • Adequate renal and hepatic function defined as: Bilirubin ≤ 1.5 times upper limit of normal (ULN); SGOT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 2.5 times ULN; Creatinine ≤ 2 times ULN.
  • For patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer (EOC/FT/PPC): patients must have completed front-line treatment within 3 months of study entry and in a complete remission; Patients treated with neoadjuvant platinum-based chemotherapy prior to definitive surgery will be eligible; If serum CA-125 was elevated at diagnosis, it must also have normalized by end of treatment.
  • For patients with breast cancer: patients must have completed adjuvant treatment with chemotherapy and radiation therapy (if recommended) within three months of study entry and deemed in complete remission; Treatment must have included adjuvant chemotherapy and radiation if recommended; Patients receiving neoadjuvant therapy will be eligible following completion of all adjuvant chemotherapy if indicated. Patients receiving hormonal therapy following chemotherapy will be eligible to participate. However, patients placed on Tamoxifen or other hormonal agents in lieu of chemotherapy will not be eligible.

Who cannot join

  • history or active secondary cancer within the last 5 years, except for superficial basal cell skin cancers
  • residual chemotherapy-induced CTCv3.0 Grade 2 or greater non-hematologic toxicity
  • they are unable to give informed consent
  • they are unable to adhere to protocol
  • Serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • concurrent uncontrolled illness
  • ongoing or active infection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Women & Infants' Hospital

    Providence, Rhode Island, 02905

Other trials in United States

About this study

Official title: A Pilot Study of the Herbal Remedy Essiac (ESIAK ®) Versus Placebo in Improving the Quality of Life in Women Completing Adjuvant Treatment for Breast or Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers.

This is a pilot feasibility study being performed in women completing front-line treatment for breast or ovarian cancer. It is being done to evaluate whether or not an herbal combination known as Essiac (ESIAK) can improve the overall quality of life in these women as they transition from active treatment to follow-up, also known as the quality of life in transition. This information will be used to design a larger randomized trial.

Read the detailed description

Complementary and Alternative medical (CAM) practices are "healthcare practices outside the realm of conventional medicine, which are yet to be validated using scientific methods". It encompasses a wide variety of behavioral (meditation, and spiritual practices) and clinical (herbal, acupuncture, and massage) techniques. Patients with chronic diseases including cancer tend to be very interested in these treatments and research involving CAM and their ability to improve quality of life are needed.

Women transitioning from active treatment for breast or ovarian cancer to surveillance (QOL-T) can experience physical and psychological distress, related to both treatment (fatigue, alopecia, and menopausal symptoms), and the diagnosis itself. Intervention during the critical time of transition from active therapy to follow-up may help patients to adjust to life after cancer treatment.

Essiac has been documented to be a popular form of herbal treatment in patients with cancer. Given its lack of reported side effects, we are interested in pursuing a formal evaluation of a Essiac in capsule formulation (ESIAK) in women surviving breast or ovarian cancers to evaluate its role in improving the overall quality of life following chemotherapy that often accompanies the end of adjuvant therapy.

Being tested
Essiac
Keywords
Treatment side effects, Quality of Life, Transition, Survivorship
Medical subject headings
Ovarian Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EssiacDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of Life

Secondary outcomes (2)

  1. Toxicity

  2. Feasibility

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2006 (estimated)
  2. Study startOct 2005
  3. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
20 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00287482
Sponsor's protocol ID
WIH042005
Status last verified
Feb 2007
First submitted
3 Feb 2006
Last updated
12 Feb 2007
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Essiac in people with Ovarian Cancer and Breast Cancer, run by Women and Infants Hospital of Rhode Island at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Life. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00287482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2007.

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