Breast Cancer

Joint Pain

Five 700 mg Capsules three times a day to equal 15 capsules per day for 3 months

Blue Citrus

Five Placebo capsules three times a day to equal 15 capsules per day for 3 months

Placebo

Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer

Pilot, Single Center Randomized Controlled, Double-Blind, Cross Over, Intent to Treat Trial of Blue Citrus to Placebo in Those Breast Cancer Patients Receiving Aromatase Inhibitor Therapy

Nathalie Johnson

Principal Investigator

Legacy Health System

Treatment with 4.8 grams PectaSol-C Modified Citrus Pectin three times a day, away from meals for six months.

Prostatic Neoplasms

Oral administration of PectaSol-C MCP (4.8 grams in six capsules three times a day away from food).

PectaSol-C Modified Citrus Pectin (MCP)

Genitourinary Oncology Service, Institute of Oncology, Meir Medical Center, Tshernichovsky 59,

Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA

Phase III, Single-Center, Open Label, Trial Evaluating the Safety and Efficacy of PectaSol-C Modified Citrus Pectin on PSA Kinetics in Prostate Cancer in the Setting of Serial Increases in PSA

PSA doubling time increase will be used to show effectiveness of the Modified Citrus pectin (MCP).

Patient tolerability of MCP will be assessed by comparing the results of weekly self-assessment diaries with baseline assessments.

At baseline (0 month), and end of study (6 month): Blood draw for serum levels of galectin-3, C-reactive protein, and lipid panel.

EcoNugenics

Dietary Supplement: PectaSol-C Modified Citrus Pectin (MCP) Oral administration of PectaSol-C MCP (4.8 grams in six capsules three times a day away from food).

limonene

Arizona Cancer Center

Limonene Study in Women With Breast Cancer

Clinical Study of Limonene in Women With a Recent Diagnosis of Early Stage Breast Cancer Electing to Undergo Excision Surgery

Sherry Chow

Research Professor of Medicine

University of Arizona

National Cancer Institute (NCI)

Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment

Patients will self-administer the study placebo twice per day (morning, evening) for 6 months, for the efficacy assessment

Alopecia

The experimental group will receive CG428. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.

CG428

The placebo group will received placebo which excluded active ingredients. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.

Danbee Kang

EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors

EValuation of the Impact of a TOpical Lotion, CG428, on Permanent Chemotherapy Induced Hair and Scalp Disorders in Cancer SUrvivors: A randoMized, Single-center, Double-blind placEbo Controlled Trial (a Pilot Study)

Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM We will take a picture of 15X and 60X on the parietal (To around 2 cm) and then analysis using Folliscope program.

Respondents will be instructed to indicate on a 4-point Likert scale on each statement (1=Not at all, 2= A little, 3=Quite a bit, 4=Very much). Total scores will be calculated by summing responses for all items; higher scores means more distress due to CIA

Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject using Canon EOS 70D

Water on scalp: it will be measured using Corneometer (Courage-Khazakaelectronic GmbH, Germany). We will measure 3 times on same area

it will be measured using Sebumeter SM815 (Courage-Khazakaelectronic GmbH, Germany). We will measure 1 times on same area

Patient self-assessment: We will measure patient reported hair density and thickness, scalp condition, and density using visual analogue scale (VAS) ranging from 0 to 10

Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.
Global photographs: We will take a picture the patients' nail using Canon EOS 70D with Intelli-Flash system or similar system

We will assess patients' body image using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 and breast specific module

We will assess patients' depression using Hospital Anxiety and Depression Scale (HADS). It consists of 14 items in two domains (Depression and anxiety).

We will assess patients' anxiety using Hospital Anxiety and Depression Scale (HADS). It consists of 14 items in two domains (Depression and anxiety).

We will use self-reported questionnaire for satisfaction with the products as well as suggestions for improvement after completion of study with patients who received the CG428.

Outcomes will be collected using objective methods and patient reported outcomes:
Objectively quantified: Hair thickness and density: We will measure hair thickness and density using Folliscope 4.0, LeadM We will take a picture on the parietal (To around 2 cm) and then analysis using Folliscope program.
Global photographs: Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject

Effort for managing hair using a questionniare whcih developed by researcher

Juhee Cho

Cancer Education Center

Samsung Medical Center

Legacy Healthcare Services

Chemotherapy Effects

EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors (VOLUME)

A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2)

Evaluation of the Impact of a Topical Lotion, CG428, on Permanent Chemotherapy Induced Hair and Scalp Disorders in Cancer Survivors: An Open-label 6 Months Extension of VOLUME Study.

Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM

Respondents will be instructed to indicate on a 4-point Likert scale on each

Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.

European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 and breast specific module

We will ask how much to willing to pay for CG428

Information about what group they belonged to in previous studies

citrus/karcinóm prsníka

Trial of Blue Citrus Compared to Placebo in Patients Receiving Aromatase Inhibitor Therapy for Estrogen Receptor Positive Post-Menopausal Breast Cancer

Effect of Modified Citrus Pectin on PSA Kinetics in Biochemical Relapsed PC With Serial Increases in PSA

Limonene Study in Women With Breast Cancer

EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors

A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2)

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