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NCT Number: NCT02148159

Acupuncture for Unintentional Weight Loss and Anorexia With GI Cancer

Patients with cancer often experience appetite loss and weight loss unintentionally. Rapid weight loss negatively impact on physical functioning, quality of life, and overall survival. Patients will be randomly assigned into two groups. An intervention with acupuncture may slow down or stop the progression of cancer-related anorexia and weight loss.

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Key information

Conditions

Malignant Neoplasm of Gastrointestinal Tract Anorexia Body Weight Body Weight Changes Cachexia Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Thinness Weight Loss

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida Clinical Research Center (CRC)

Gainesville, Florida, 32610-0219, United States

About this study

The purpose of this research study is to investigate if acupuncture helps to improve appetite and slow down unintentional weight loss. The participants will be randomly divided into two groups and receive 8 sessions of acupuncture (two groups will receive different acupuncture points) for 8 weeks. During the study period, participants will be asked various questions about appetite, physical functioning, cancer-related symptoms and quality of life to understand changes related to body weight, as well as blood samples. The research team members will collect data regarding changes in appetite, body weight, body composition, and physical functioning.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21 year or older
  • medical diagnosis of gastrointestinal cancer (for example, gastric, biliary, or colorectal)
  • experienced weight loss of at least 5% over the last 6 months
  • ability to communicate in English
  • ability to follow the research protocol

Exclusion criteria

  • plan to have surgical procedures at the time of recruitment
  • receive radiation therapy alone or in addition to chemotherapy during the study period
  • undergo surgery during the study or in the months prior to the study
  • no plan to have chemotherapy after the surgery
  • any comorbidities that may affect the interpretation of study findings
  • open burn sites or infected wounds
  • esophageal cancer or pancreatic cancer
  • life expectancy of less than 6 months as assessed by attending physician

Treatment and study plan

Cachexia Acupuncture-A (Peace Classic Needles® )

Device

Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.

Other names: Acu-Market, Mechanism based acupuncture

General Acupuncture-B (Peace Classic Needles®)

Device

Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.

Other names: Acu-Market, General acupuncture

Primary outcomes

  1. Percentage weight change over 8 weeks between two arms

    Time frame: up to 8 weeks

    Weight will be measured each visit (pounds).

Secondary outcomes

  1. Appetite change between two arms

    Time frame: up to 8 weeks

    Three different short survey forms will be used to measure appetite change. Visual analogue scale (0 indicates no appetite and 10 is the best appetite). Simplified Nutritional Appetite Questionnaire score (min-max: 4-20 and the higher the better appetite) Patient Generated Subjective Global Assessment: 0-1, no intervention is needed. 9 or higher score indicates critical intervention.

  2. physical functioning

    Time frame: up to 8 weeks

    survey form (min-max: 0-100, increment by 10%- 100% indicates full functioning).

  3. body composition

    Time frame: up to 8 weeks

    Small, non-invasive device (bioelectrical impedance analysis) like a miniature version of EKG will measure changes in body composition (numeric scale).

Other outcomes

  1. Quality of life between two arms

    Time frame: up to 8 weeks

    Survey format includes the 27 items (5 points scale: 0 means 'not at all' and 4 means 'very much") .

  2. biomarkers

    Time frame: weeks 1, 4 and 8 (three measurements)

    Small amounts of blood will be drawn.

  3. symptom experience

    Time frame: up to 8 weeks

    Survey format: 13 areas related to the symptom experience and patient's concerns will be assessed (4 points scale; 0 means 'not at all' and 3 means 'very much').

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Impact of Mechanism Based Acupuncture Intervention to Improve Weight Loss in GI Cancer Patients With Cachexia

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 28, 2014
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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